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Medical Devices Essential Principles Checklist Manufacturers must demonstrate their medical device complies with the Essential Principles. Manufacturers must generate, collate, assess, and maintain scientific and clinical evidence that shows that their devices comply with the Essential Principles. The evidence must be relevant to the device's intended purpose and must be objective, sufficient, and robust. • The Essential Principles Checklist is a template that may help you: – identify the safety and performance requirements that apply to your device – document a rationale for any of the safety and performance requirements that aren't relevant – summarise the evidence you hold in support of each of the relevant safety and performance requirements • Completing the checklist could help you: – apply for an International conformity assessment certificate – comply with regulations as part of a post-market review or investigation – to determine if you have considered and addressed all the requirements with supporting evidence Instructions • Complete this checklist for each new medical device conformity assessment application • Provide an updated checklist if applicable, for change applications relating to your medical device. • The checklist must be applicable to the subject medical devices or may be completed for a family or group of devices. • Complete the checklist as outlined in the table instructions below

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Table instructions Applicable Not applicable Medical Devices / IVD Evidence of compliance Reference to IMDRF GUIDELINES (Essential Justification must be standard or other Include direct reference to Principles of Safety and Performance of Medical provided below procedure applied documents within the Devices and IVD Medical Devices) manufacturer’s quality system EP No.# Title of the Essential Principle EP.x The Essential Principle requirement is contained here. ☐ ☐ List here the standards / procedures This column is to contain direct No.# Tick this box if Tick this box if the applied with justification (include reference to documents within the the Essential Essential Principle number / title / version). These manufacturer’s quality system such Principle requirement is not include (but are not limited to): as: requirement is applicable to your • EN ISO international, local • study results applicable to device / family of standards • test reports the device / devices. Then • company procedures family of provide justification. • design outputs devices. • others identified by number / title / version Complete the two columns on the right. Medical Devices Essential Principles Checklist ANARME, IP Page 2 of 47

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Part 1: GENERAL PRINCIPLES Applicable Not applicable Medical Devices / IVD standard or Evidence of compliance other procedure applied Part 1. GENERAL PRINCIPLES Justification must be List here the standards / procedures Include direct reference to provided below documents within the applied with justification manufacturer’s quality system 1 Use of medical devices not to compromise health and ☐ ☐ List here the standards / procedures Include direct reference to documents safety Provide Justification applied with justification within the manufacturer’s quality A medical device is to be designed and produced in a way that system ensures that: (a) the device will not compromise the clinical condition or safety of a patient, or the safety and health of the user of any other person, when the device is used on a patient under the conditions and for the purposes for which the device was intended and, if applicable, by a user with appropriate technical knowledge, experience, education or training; and 1 (cont.) (b) any risks associated with the use of the device are: ☐ ☐ List here the standards / procedures Include direct reference to documents (i) acceptable risks when weighed against the Provide Justification applied with justification within the manufacturer’s quality intended benefit to the patient; and system (ii) compatible with a high level of protection of health and safety. 2 Design and construction of medical devices to conform ☐ ☐ List here the standards / procedures Include direct reference to documents with safety principles Provide Justification applied with justification within the manufacturer’s quality (1) The solutions adopted by the manufacturer for the design system and construction of a medical device must conform with safety principles, having regard to the generally acknowledged state of the art. 2 (cont.) (2) Without limiting subclause (1), in selecting appropriate ☐ ☐ List here the standards / procedures Include direct reference to documents solutions for the design and construction of a medical device so as Provide Justification applied with justification within the manufacturer’s quality to minimise any risks associated with the use of the device, system the manufacturer must: (a) first, identify hazards and associated risks arising from the use of the device for its intended purpose, and Medical Devices Essential Principles Checklist ANARME, IP Page 3 of 47

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foreseeable misuse of the device; and Applicable Not applicable Medical Devices / IVD standard or Evidence of compliance other procedure applied Part 1. GENERAL PRINCIPLES Justification must be List here the standards / procedures Include direct reference to provided below documents within the applied with justification manufacturer’s quality system 2(2) (b) second, eliminate, or reduce, these risks as far as possible ☐ ☐ List here the standards / procedures Include direct reference to documents (cont.) by adopting a policy of inherently safe design and Provide Justification applied with justification within the manufacturer’s quality construction; and system 2(2) (c) third, if appropriate, ensure that adequate protection ☐ ☐ List here the standards / procedures Include direct reference to documents (cont.) measures are taken, including alarms if necessary, in Provide Justification applied with justification within the manufacturer’s quality relation to any risks that cannot be eliminated; and system 2(2) (d) fourth, inform users of any residual risks that may arise ☐ ☐ List here the standards / procedures Include direct reference to documents (cont.) due to any shortcomings of the protection measures Provide Justification applied with justification within the manufacturer’s quality adopted. system 2 (cont.) (3) In paragraph 2 (d): ☐ ☐ List here the standards / procedures Include direct reference to documents residual risk, for a medical device, means the risk remaining Provide Justification applied with justification within the manufacturer’s quality after the measures described in paragraphs (2) (a), (b) and system (c) have been applied. 3 Medical devices to be suitable for intended purpose ☐ ☐ List here the standards / procedures Include direct reference to documents A medical device must: Provide Justification applied with justification within the manufacturer’s quality system (a) perform in the way intended by the manufacturer; and 3 (cont.) (b) be designed, produced and packaged in a way that ☐ ☐ List here the standards / procedures Include direct reference to documents ensures that it is suitable for one or more of the purposes Provide Justification applied with justification within the manufacturer’s quality mentioned in the definition of medical device system 4 Long-term safety ☐ ☐ List here the standards / procedures Include direct reference to documents A medical device must be designed and produced in a way that Provide Justification applied with justification within the manufacturer’s quality ensures that if: system (a) the device is used within the period, indicated by the manufacturer, in which the device can be safely used; and Medical Devices Essential Principles Checklist ANARME, IP Page 4 of 47

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4 (cont.) (b) the device is not subjected to stresses that are outside the ☐ ☐ List here the standards / procedures Include direct reference to documents stresses that can occur during normal conditions of use; and Provide Justification applied with justification within the manufacturer’s quality system Applicable Not applicable Medical Devices / IVD standard or Evidence of compliance other procedure applied Part 1. GENERAL PRINCIPLES Justification must be List here the standards / procedures Include direct reference to provided below documents within the applied with justification manufacturer’s quality system 4 (cont.) (c) the device is regularly maintained and calibrated in ☐ ☐ List here the standards / procedures Include direct reference to documents accordance with the manufacturer’s instructions; Provide Justification applied with justification within the manufacturer’s quality system 4 (cont.) the characteristics and performances mentioned in clauses 1, 2 and ☐ ☐ List here the standards / procedures Include direct reference to documents 3 are not adversely affected. Provide Justification applied with justification within the manufacturer’s quality system 5 Medical devices not to be adversely affected by transport ☐ ☐ List here the standards / procedures Include direct reference to documents or storage Provide Justification applied with justification within the manufacturer’s quality A medical device must be designed, produced and packed in a system way that ensures that the characteristics and performance of the device when it is being used for its intended purpose will not be adversely affected during transport and storage that is carried out taking account of the instructions and information provided by the manufacturer. 6 Benefits of medical devices to outweigh any undesirable ☐ ☐ List here the standards / procedures Include direct reference to documents effects Provide Justification applied with justification within the manufacturer’s quality The benefits to be gained from the use of a medical device for the system performance intended by the manufacturer must outweigh any undesirable effects arising from its use. Medical Devices Essential Principles Checklist ANARME, IP Page 5 of 47

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Part 2: PRINCIPLES ABOUT DESIGN AND CONSTRUCTION EP 7: Chemical, physical and biological properties Part 2. Applicable Not applicable Medical Devices / IVD Evidence of compliance Justification must be standard or other Include direct reference to PRINCIPLES ABOUT DESIGN AND CONSTRUCTION provided below procedure applied documents within the manufacturer’s quality system 7 Chemical, physical and biological properties 7.1 Choice of materials ☐ ☐ List here the standards / procedures Include direct reference to documents In ensuring that the requirements of Part 1 are met in relation to a Provide Justification applied with justification within the manufacturer’s quality medical device, particular attention must be given to: system (a) the chemical and physical properties of the materials used in the device; and 7.1 (b) the compatibility between the materials used and biological ☐ ☐ List here the standards / procedures Include direct reference to documents (cont.) tissues, cells, body fluids and specimens; Provide Justification applied with justification within the manufacturer’s quality system 7.1 having regard to the intended purpose of the device. ☐ ☐ List here the standards / procedures Include direct reference to documents (cont.) Provide Justification applied with justification within the manufacturer’s quality system 7.2 Minimisation of risks associated with contaminants and ☐ ☐ List here the standards / procedures Include direct reference to documents residues Provide Justification applied with justification within the manufacturer’s quality (1) A medical device must be designed, produced and packed in a system way that ensures that any risks associated with contaminants and residues that may affect a person who is involved in transporting, storing or using the device, or a patient, are minimised, having regard to the intended purpose of the device. 7.2 (2) In minimising risks, particular consideration must be given to the ☐ ☐ List here the standards / procedures Include direct reference to documents (cont.) likely duration and frequency of any tissue exposure associated Provide Justification applied with justification within the manufacturer’s quality with the transportation, storage or use of the system device. Medical Devices Essential Principles Checklist ANARME, IP Page 6 of 47

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Part 2. Applicable Not applicable Medical Devices / IVD Evidence of compliance Justification must be standard or other Include direct reference to PRINCIPLES ABOUT DESIGN AND CONSTRUCTION provided below procedure applied documents within the manufacturer’s quality system 7 Chemical, physical and biological properties 7.3 Ability to be used safely with materials, etc ☐ ☐ List here the standards / procedures Include direct reference to documents (1) A medical device must be designed and produced in a way that Provide Justification applied with justification within the manufacturer’s quality system ensures that the device can be used safely with any material, substance or gas with which the device may come into contact during normal use or use in routine procedures. 7.3 (2) If the device is intended to be used to administer medicine, it ☐ ☐ List here the standards / procedures Include direct reference to documents (cont.) must be designed and produced in a way that ensures that the Provide Justification applied with justification within the manufacturer’s quality device: system (a) is compatible with the provisions and restrictions applying to the medicine to be administered; and 7.3 (b) allows the medicine to perform as intended. ☐ ☐ List here the standards / procedures Include direct reference to documents (cont.) Provide Justification applied with justification within the manufacturer’s quality system 7.4 Verification of incorporated substance ☐ ☐ List here the standards / procedures Include direct reference to documents (1) If a medical device incorporates, or is intended to incorporate, as Provide Justification applied with justification within the manufacturer’s quality system an integral part, a substance that, if used separately, might be considered to be a medicine that is intended to act on a patient in a way that is ancillary to the device: (a) the safety and quality of the substance must be verified in accordance with the requirements for medicines; and 7.4 (b) the ancillary action of the substance must be verified having ☐ ☐ List here the standards / procedures Include direct reference to documents (cont.) regard to the intended purpose of the device. Provide Justification applied with justification within the manufacturer’s quality system 7.4 (2) For the purposes of this clause, any stable derivative of human ☐ ☐ List here the standards / procedures Include direct reference to documents (cont.) blood or human plasma is considered to be a Provide Justification applied with justification within the manufacturer’s quality medicine. system 7.5 Minimisation of risks associated with leaching substances ☐ ☐ List here the standards / procedures Include direct reference to documents A medical device must be designed and produced in a way that Provide Justification applied with justification within the manufacturer’s quality system Medical Devices Essential Principles Checklist ANARME, IP Page 7 of 47

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ensures that any risks associated with substances that may leach from the device are minimised. Part 2. Applicable Not applicable Medical Devices / IVD Evidence of compliance Justification must be standard or other Include direct reference to PRINCIPLES ABOUT DESIGN AND CONSTRUCTION provided below procedure applied documents within the manufacturer’s quality system 7 Chemical, physical and biological properties 7.6 Minimisation of risks associated with ingress or egress of ☐ ☐ List here the standards / procedures Include direct reference to documents substances Provide Justification applied with justification within the manufacturer’s quality A medical device must be designed and produced in a way that system ensures that any risks associated with unintentional ingress of substances into, or unintentional egress of substances out of, the device are minimised, having regard to the nature of the environment in which the device is intended to be used. 7.7 Minimisation of risks associated with nanomaterials ☐ ☐ List here the standards / procedures Include direct reference to documents (1) A medical device must be designed and produced in a way that Provide Justification applied with justification within the manufacturer’s quality system ensures that any risks associated with the size and the properties of particles which are, or can be, released into a patient’s or user’s body are minimised. 7.7 (2) In minimising risks, particular attention must be given to the use ☐ ☐ List here the standards / procedures Include direct reference to documents (cont.) of nanomaterials. Provide Justification applied with justification within the manufacturer’s quality system 7.7 (3) Subclause (1) does not apply to particles that come into contact ☐ ☐ List here the standards / procedures Include direct reference to documents (cont.) with intact skin only. Provide Justification applied with justification within the manufacturer’s quality system Medical Devices Essential Principles Checklist ANARME, IP Page 8 of 47

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EP 8: Infection and microbial contamination Part 2. Applicable Not applicable Medical Devices / IVD Evidence of compliance Justification must be standard or other Include direct reference to documents PRINCIPLES ABOUT DESIGN AND CONSTRUCTION provided below procedure applied within the manufacturer’s quality system 8. Infection and microbial contamination 8.1 Minimisation of risk of infection and contamination ☐ ☐ List here the standards / Include direct reference to documents (1) A medical device must be designed and produced in a way that Provide Justification procedures applied with within the manufacturer’s quality justification system ensures that the risk of infection to a patient, a user, or any other person, is eliminated or minimised. 8.1 (2) The device must be designed in a way that: ☐ ☐ List here the standards / Include direct reference to documents (cont.) (a) allows it to be easily handled; and Provide Justification procedures applied with within the manufacturer’s quality justification system 8.1 (b) if appropriate, minimises contamination of the device or ☐ ☐ List here the standards / Include direct reference to documents (cont.) specimen by the patient, user or other person; and Provide Justification procedures applied with within the manufacturer’s quality justification system 8.1 (c) if appropriate, minimises contamination of the patient, user ☐ ☐ List here the standards / Include direct reference to documents (cont.) or other person by the device or specimen. Provide Justification procedures applied with within the manufacturer’s quality justification system 8.2 Control of animal, microbial or recombinant tissues, ☐ ☐ List here the standards / Include direct reference to documents tissue derivatives, cells and other substances Provide Justification procedures applied with within the manufacturer’s quality (1) This clause applies in relation to a medical device that justification system contains: (a) tissues, tissue derivatives, cells or substances or animal origin that have been rendered non-viable; and 8.2 (b) tissues, tissue derivatives, cells or substances of microbial or ☐ ☐ List here the standards / Include direct reference to documents (cont.) recombinant origin. Provide Justification procedures applied with within the manufacturer’s quality justification system 8.2 (2) If the tissues, tissue derivatives, cells or substances originated from ☐ ☐ List here the standards / Include direct reference to documents (cont.) animals, the animals must have been subjected to appropriate Provide Justification procedures applied with within the manufacturer’s quality veterinary controls and supervision, having regard to the intended justification system Medical Devices Essential Principles Checklist ANARME, IP Page 9 of 47

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use of the tissues, tissue derivatives, cells or substances. Part 2. Applicable Not applicable Medical Devices / IVD Evidence of compliance Justification must be standard or other Include direct reference to documents PRINCIPLES ABOUT DESIGN AND CONSTRUCTION provided below procedure applied within the manufacturer’s quality system 8. Infection and microbial contamination 8.2 (3) If the medical device contains tissues, tissue derivatives, cells or ☐ ☐ List here the standards / Include direct reference to documents (cont.) substances of animal origin, a record must be kept of the country Provide Justification procedures applied with within the manufacturer’s quality of origin of each animal from which the tissues, tissue derivatives, justification system cells or substances originated. 8.2 (4) The processing, preservation, testing and handling of tissues, tissue ☐ ☐ List here the standards / Include direct reference to documents (cont.) derivatives, cells or substances of animal, microbial or recombinant Provide Justification procedures applied with within the manufacturer’s quality origin must be carried out in a way that ensures the highest justification system standards of safety for a patient, the user of the device, and any other person. 8.2 (5) In particular, the production process must implement validated ☐ ☐ List here the standards / Include direct reference to documents (cont.) methods of elimination, or inactivation, in relation to viruses and Provide Justification procedures applied with within the manufacturer’s quality other transmissible agents. justification system Note: This may not apply to certain IVD medical devices if the characteristics mentioned in subclause 8.2(5) are integral to the intended purpose of the IVD medical device. 8.3 Medical devices to be supplied in a sterile state ☐ ☐ List here the standards / Include direct reference to documents (1) This clause applies in relation to a medical device that is Provide Justification procedures applied with within the manufacturer’s quality justification system intended by the manufacturer to be supplied in a sterile state. 8.3 (2) The device must be designed, produced and packed in a way that ☐ ☐ List here the standards / Include direct reference to documents (cont.) ensures that the device is sterile when it is supplied, and will Provide Justification procedures applied with within the manufacturer’s quality remain sterile, if stored and transported in accordance with the justification system directions of the manufacturer, until the protective packaging is opened or damaged. 8.3 (3) The device must be produced and sterilised using an appropriate ☐ ☐ List here the standards / Include direct reference to documents (cont.) validated method. Provide Justification procedures applied with within the manufacturer’s quality justification system Medical Devices Essential Principles Checklist ANARME, IP Page 10 of 47

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8.3 (4) The device must be produced in appropriately controlled ☐ ☐ List here the standards / Include direct reference to documents (cont.) conditions. Provide Justification procedures applied with within the manufacturer’s quality justification system Part 2. Applicable Not applicable Medical Devices / IVD Evidence of compliance Justification must be standard or other Include direct reference to documents PRINCIPLES ABOUT DESIGN AND CONSTRUCTION provided below procedure applied within the manufacturer’s quality system 8. Infection and microbial contamination 8.4 Medical devices to be supplied in a non-sterile state ☐ ☐ List here the standards / Include direct reference to documents (1) A medical device that is intended by the manufacturer to be Provide Justification procedures applied with within the manufacturer’s quality justification system supplied in a non-sterile state must be packed in a way that ensures that the device maintains the level of cleanliness stipulated by the manufacturer. 8.4 (2) If the device is intended to be sterilised before it is used, the ☐ ☐ List here the standards / Include direct reference to documents (cont.) device must be packed in a way that: Provide Justification procedures applied with within the manufacturer’s quality justification system (a) ensures that the risk of microbial contamination is minimised; and 8.4(2) (b) is suitable, having regard to the method of sterilisation that ☐ ☐ List here the standards / Include direct reference to documents (cont.) the manufacturer indicates is to be used for the device. Provide Justification procedures applied with within the manufacturer’s quality justification system 8.4 (3) The device must be produced in appropriately controlled ☐ ☐ List here the standards / Include direct reference to documents (cont.) conditions. Provide Justification procedures applied with within the manufacturer’s quality justification system 8.5 Distinction between medical devices supplied in sterile ☐ ☐ List here the standards / Include direct reference to documents and non-sterile state Provide Justification procedures applied with within the manufacturer’s quality If a medical device is supplied in both a sterile state and a justification system non-sterile state, the information provided with the device must clearly indicate whether the device is in a sterile state or a non-sterile state. Medical Devices Essential Principles Checklist ANARME, IP Page 11 of 47

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EP 9: Construction and environmental properties Part 2. Applicable Not applicable Medical Devices / IVD Evidence of compliance Justification must be standard or other Include direct reference to documents PRINCIPLES ABOUT DESIGN AND CONSTRUCTION provided below procedure applied within the manufacturer’s quality system 9 Construction and environmental properties 9.1 Medical devices intended to be used in combination with ☐ ☐ List here the standards / Include direct reference to documents other devices or equipment Provide Justification procedures applied with within the manufacturer’s quality A medical device that is intended by the manufacturer to be used in justification system combination with another medical device or other equipment (including a connection system) must be designed and produced in a way that ensures that: (a) the medical device, and any other device or equipment with which it is used, operate in a safe way; and 9.1 (b) the intended performance of the device, and any other device ☐ ☐ List here the standards / Include direct reference to documents (cont.) or equipment with which it is used, is not impaired. Provide Justification procedures applied with within the manufacturer’s quality justification system 9.2 Minimisation of risks associated with use of medical ☐ ☐ List here the standards / Include direct reference to documents devices Provide Justification procedures applied with within the manufacturer’s quality A medical device must be designed and produced in a way that justification system ensures that, as far as practicable, the following risks are removed or minimised: (a) the risk of injury arising from the physical features of the device; 9.2 (b) any risks associated with reasonably foreseeable ☐ ☐ List here the standards / Include direct reference to documents (cont.) environmental conditions Provide Justification procedures applied with within the manufacturer’s quality justification system 9.2 (c) the risk of reciprocal interference involving other devices ☐ ☐ List here the standards / Include direct reference to documents (cont.) that are normally used in an investigation or treatment of the Provide Justification procedures applied with within the manufacturer’s quality kind for which the device is intended to be used; justification system 9.2 (d) any risks arising if maintenance or calibration of the device ☐ ☐ List here the standards / Include direct reference to documents (cont.) is not possible; Provide Justification procedures applied with within the manufacturer’s quality justification system 9.2 (e) any risks associated with the ageing of materials used in the ☐ ☐ List here the standards / Include direct reference to documents (cont.) device; procedures applied with within the manufacturer’s quality Medical Devices Essential Principles Checklist ANARME, IP Page 12 of 47

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Provide Justification justification system Part 2. Applicable Not applicable Medical Devices / IVD Evidence of compliance Justification must be standard or other Include direct reference to documents PRINCIPLES ABOUT DESIGN AND CONSTRUCTION provided below procedure applied within the manufacturer’s quality system 9 Construction and environmental properties 9.2 (f) any risks associated with the loss of accuracy of any ☐ ☐ List here the standards / Include direct reference to documents (cont.) measuring or control mechanism of the device; Provide Justification procedures applied with within the manufacturer’s quality justification system 9.2 (g) the risk of fire or explosion occurring during normal use of ☐ ☐ List here the standards / Include direct reference to documents (cont.) the device, and in the event of a single fault condition, Provide Justification procedures applied with within the manufacturer’s quality especially if the device is intended to be exposed to justification system flammable substances or substances that can cause combustion; 9.2 (h) the risks associated with disposal of any waste substances. ☐ ☐ List here the standards / Include direct reference to documents (cont.) Provide Justification procedures applied with within the manufacturer’s quality justification system Medical Devices Essential Principles Checklist ANARME, IP Page 13 of 47

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EP 10: Medical devices with a measuring function Applicable Not applicable Medical Devices / IVD Evidence of compliance Part 2. Justification must be standard or other Include direct reference to documents PRINCIPLES ABOUT DESIGN AND CONSTRUCTION provided below procedure applied within the manufacturer’s quality system 10 Medical devices with a measuring function 10 (1) A medical device that has a measuring function must be ☐ ☐ List here the standards / Include direct reference to documents designed and produced in a way that ensures that the device Provide Justification procedures applied with within the manufacturer’s quality provides accurate, precise and stable measurements within the justification system limits indicated by the manufacturer and having regard to the intended purpose of the device. 10 (2) The measurement, monitoring and display scale of the device must ☐ ☐ List here the standards / Include direct reference to documents (cont.) be designed and produced in accordance with ergonomic Provide Justification procedures applied with within the manufacturer’s quality principles, having regard to the intended purpose of the device justification system 10 (3) The measurements made by the device must be expressed: ☐ ☐ List here the standards / Include direct reference to documents (cont.) (a) in International legal units of measurement or be compared to Provide Justification procedures applied with within the manufacturer’s quality justification system at least one point of reference indicated in International legal units of measurement; or 10 (b) if the device measures a physical quantity for which no ☐ ☐ List here the standards / Include direct reference to documents (cont.) International legal unit of measurement has been Provide Justification procedures applied with within the manufacturer’s quality prescribed. justification system Medical Devices Essential Principles Checklist ANARME, IP Page 14 of 47

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EP 11: Protection against radiation Part 2. Applicable Not applicable Medical Devices / IVD Evidence of compliance Justification must be standard or other Include direct reference to documents PRINCIPLES ABOUT DESIGN AND CONSTRUCTION provided below procedure applied within the manufacturer’s quality system 11 Protection against radiation 11.1 Minimisation of exposure to radiation ☐ ☐ List here the standards / Include direct reference to documents A medical device must be designed and produced in a way that Provide Justification procedures applied with within the manufacturer’s quality ensures that the exposure of a patient, the user, or any other justification system person, to radiation is minimised, having regard to the levels of radiation required to enable the device to perform its therapeutic and diagnostic functions and the intended purpose of the device. 11.2 Medical devices intended to emit radiation ☐ ☐ List here the standards / Include direct reference to documents (1) This clause applies in relation to a medical device that is Provide Justification procedures applied with within the manufacturer’s quality justification system intended by a manufacturer to emit hazardous levels of visible or invisible radiation because the emission is necessary for a specific medical purpose, the benefit of which is considered to outweigh the risks inherent in the emission. 11.2 (2) The device must be designed and produced in a way that ☐ ☐ List here the standards / Include direct reference to documents (cont.) ensures that the user can control the level of the emission. Provide Justification procedures applied with within the manufacturer’s quality justification system 11.2 (3) The device must be designed and produced in a way that ensures ☐ ☐ List here the standards / Include direct reference to documents (cont.) the reproducibility and tolerance of relevant variable parameters. Provide Justification procedures applied with within the manufacturer’s quality justification system 11.2 (4) If practicable, the device must be fitted with a visual indicator or ☐ ☐ List here the standards / Include direct reference to documents (cont.) an audible warning, or both, that operates if potentially Provide Justification procedures applied with within the manufacturer’s quality hazardous levels of radiation are emitted. justification system 11.3 Minimisation of exposure to unintended radiation ☐ ☐ List here the standards / Include direct reference to documents A medical device must be designed and produced in a way that Provide Justification procedures applied with within the manufacturer’s quality ensures that the exposure of a patient, the user, or any other justification system Medical Devices Essential Principles Checklist ANARME, IP Page 15 of 47

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person, to the emission of unintended, stray or scattered radiation is minimised. Part 2. Applicable Not applicable Medical Devices / IVD Evidence of compliance Justification must be standard or other Include direct reference to documents PRINCIPLES ABOUT DESIGN AND CONSTRUCTION provided below procedure applied within the manufacturer’s quality system 11 Protection against radiation 11.4 Operating instructions ☐ ☐ List here the standards / Include direct reference to documents The operating instructions for a medical device that emits radiation Provide Justification procedures applied with within the manufacturer’s quality must include detailed information about the following matters: justification system (a) the nature of the radiation emitted; 11.4 (b) the means by which patients and users can be protected from ☐ ☐ List here the standards / Include direct reference to documents (cont.) the radiation; Provide Justification procedures applied with within the manufacturer’s quality justification system 11.4 (c) ways to avoid misusing the device ☐ ☐ List here the standards / Include direct reference to documents (cont.) Provide Justification procedures applied with within the manufacturer’s quality justification system 11.4 (d) ways to eliminate any risks inherent in the installation of ☐ ☐ List here the standards / Include direct reference to documents (cont.) the device. Provide Justification procedures applied with within the manufacturer’s quality justification system 11.5 Medical devices intended to emit ionising radiation – ☐ ☐ List here the standards / Include direct reference to documents additional requirements Provide Justification procedures applied with within the manufacturer’s quality (1) This clause applies, in addition to clauses 11.1 to 11.4, in relation to justification system a medical device that is intended by the manufacturer to emit ionising radiation. 11.5 (2) The device must be designed and produced in a way that ensures ☐ ☐ List here the standards / Include direct reference to documents (cont.) that, if practicable, the quantity, geometry and energy distribution Provide Justification procedures applied with within the manufacturer’s quality (or quality) of radiation emitted can be controlled and varied, justification system having regard to the intended purpose of the device. Medical Devices Essential Principles Checklist ANARME, IP Page 16 of 47

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11.5 (3) If the device is intended to be used for diagnostic radiology, ☐ ☐ List here the standards / Include direct reference to documents (cont.) the device must be designed and produced in a way that Provide Justification procedures applied with within the manufacturer’s quality ensures that, when used in relation to a patient for a purpose justification system intended by the manufacturer; (a) the device achieves an appropriate image or output quality for that purpose; and Part 2. Applicable Not applicable Medical Devices / IVD Evidence of compliance Justification must be standard or other Include direct reference to documents PRINCIPLES ABOUT DESIGN AND CONSTRUCTION provided below procedure applied within the manufacturer’s quality system 11 Protection against radiation 11.5(3) (b) the exposure of the patient, or the user, to radiation is ☐ ☐ List here the standards / Include direct reference to documents (cont.) minimised. Provide Justification procedures applied with within the manufacturer’s quality justification system 11.5 (4) if the device is intended to be used for therapeutic radiology, the ☐ ☐ List here the standards / Include direct reference to documents (cont.) device must be designed and produced in a way that ensures Provide Justification procedures applied with within the manufacturer’s quality that the delivered dose of radiation, the type and energy of the justification system radiation beam, and, if appropriate, the energy distribution of the radiation beam, can be reliably controlled and monitored. EP 12: Medical devices connected to or equipped with an energy source Part 2. Applicable Not applicable Medical Devices / IVD Evidence of compliance Justification must be standard or other Include direct reference to PRINCIPLES ABOUT DESIGN AND CONSTRUCTION provided below procedure applied documents within the manufacturer’s quality system 12 Medical devices connected to or equipped with an energy source 12 Programmed or programmable medical device or software that ☐ ☐ List here the standards / Include direct reference to documents is a medical device procedures applied with within the manufacturer’s quality Medical Devices Essential Principles Checklist ANARME, IP Page 17 of 47

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(1) A programmed or programmable medical device, or Provide Justification justification system software that is a medical device, that is intended to make use of either or both of data and information must be designed and produced in a way that ensures that: (a) the safety, performance, reliability, accuracy, precision, useability, security and repeatability of the device are appropriate for the intended purpose of the device; and 12.1(1) (b) any consequent risks, or impairment of performance, ☐ ☐ List here the standards / Include direct reference to documents (cont.) associated with one or more fault conditions is Provide Justification procedures applied with within the manufacturer’s quality eliminated or appropriately reduced; and justification system Part 2. Applicable Not applicable Medical Devices / IVD Evidence of compliance Justification must be standard or other Include direct reference to PRINCIPLES ABOUT DESIGN AND CONSTRUCTION provided below procedure applied documents within the manufacturer’s quality system 12 Medical devices connected to or equipped with an energy source 12.1(1) (c) the device is resilient with respect to interactions that ☐ ☐ List here the standards / Include direct reference to documents (cont.) could occur during the use of the device and that Provide Justification procedures applied with within the manufacturer’s quality could result in unsafe performance of the device; and justification system 12.1(1) (d) if relevant to the safety of a patient, or the safety and ☐ ☐ List here the standards / Include direct reference to documents (cont.) health of the user or any other person, the device Provide Justification procedures applied with within the manufacturer’s quality provides suitable warnings in a timely manner: justification system (i) following the disruption to services upon which the device is dependent for the device’s operation; and 12.1(1)(d) (ii) following the performance of the device being ☐ ☐ List here the standards / Include direct reference to documents (cont.) adversely affected; and Provide Justification procedures applied with within the manufacturer’s quality justification system 12.1(1) (e) if relevant to the safety of a patient, or the safety and ☐ ☐ List here the standards / Include direct reference to documents (cont.) health of the user or any other person, the device Provide Justification procedures applied with within the manufacturer’s quality provides a means by which the user can verify correct justification system Medical Devices Essential Principles Checklist ANARME, IP Page 18 of 47

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operation of the device; and 12.1(1) (f) if relevant to the safety of a patient, or the safety and ☐ ☐ List here the standards / Include direct reference to documents (cont.) health of the user or any other person, the integrity Provide Justification procedures applied with within the manufacturer’s quality and quality of the data or information is maintained; justification system and 12.1(1) (g) if relevant, the privacy of the data or information is ☐ ☐ List here the standards / Include direct reference to documents (cont.) maintained. Provide Justification procedures applied with within the manufacturer’s quality justification system 12.1 (cont.) (2) A programmed or programmable medical device, or software ☐ ☐ List here the standards / Include direct reference to documents that is a medical device, must be developed, produced and Provide Justification procedures applied with within the manufacturer’s quality maintained having regard to the generally acknowledged state justification system of the art (including for design, development life cycle, development environment, version control, quality and risk management, security, verification and validation, change and configuration management and problem resolution). Part 2. Applicable Not applicable Medical Devices / IVD Evidence of compliance Justification must be standard or other Include direct reference to PRINCIPLES ABOUT DESIGN AND CONSTRUCTION provided below procedure applied documents within the manufacturer’s quality system 12 Medical devices connected to or equipped with an energy source 12.1 (cont.) (3) A programmed or programmable medical device, or software ☐ ☐ List here the standards / Include direct reference to documents that is a medical device, that is intended to be used in Provide Justification procedures applied with within the manufacturer’s quality combination with computing platforms must be designed and justification system developed taking into account the capability, resources and configuration of the platforms and the external factors (including information technology environments) related to the use of the platforms 12.1 (cont.) (4) The manufacturer of a programmed or programmable medical ☐ ☐ List here the standards / Include direct reference to documents device, or software that is a medical device, must provide Provide Justification procedures applied with within the manufacturer’s quality instructions or information with the device that sets out justification system Medical Devices Essential Principles Checklist ANARME, IP Page 19 of 47

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requirements (including requirements about hardware, software, information technology environments and security measures) necessary to operate the device as intended. 12.1 (cont.) (5) A programmed or programmable medical device, or ☐ ☐ List here the standards / Include direct reference to documents software that is a medical device, must be designed, Provide Justification procedures applied with within the manufacturer’s quality produced and maintained with regard to best practice in justification system relation to software, security and engineering to provide cybersecurity of the device, including where appropriate the following: (a) protection against unauthorised access, unauthorised influence or unauthorised manipulation; 12.1(5) (b) minimisation of risks associated with known ☐ ☐ List here the standards / Include direct reference to documents (cont.) cybersecurity vulnerabilities (including either or both of Provide Justification procedures applied with within the manufacturer’s quality remediation of known vulnerabilities and application of justification system compensating controls); 12.1(5) (c) facilitation of the application of updates, patches, ☐ ☐ List here the standards / Include direct reference to documents (cont.) compensating controls and other improvements; Provide Justification procedures applied with within the manufacturer’s quality justification system Part 2. Applicable Not applicable Medical Devices / IVD Evidence of compliance Justification must be standard or other Include direct reference to PRINCIPLES ABOUT DESIGN AND CONSTRUCTION provided below procedure applied documents within the manufacturer’s quality system 12 Medical devices connected to or equipped with an energy source 12.1(5) (d) disclosure of known vulnerabilities in the device or its ☐ ☐ List here the standards / Include direct reference to documents (cont.) components and associated mitigations; Provide Justification procedures applied with within the manufacturer’s quality justification system 12.1(5) (e) making available sufficient information for a user to ☐ ☐ List here the standards / Include direct reference to documents (cont.) make decisions with respect to the safety of applying, or Provide Justification procedures applied with within the manufacturer’s quality not applying, updates, patches, compensating justification system controls and other improvements. Medical Devices Essential Principles Checklist ANARME, IP Page 20 of 47

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12.1 (cont.) (6) The manufacturer of a programmed or programmable ☐ ☐ List here the standards / Include direct reference to documents medical device, or software that is a medical device, having Provide Justification procedures applied with within the manufacturer’s quality regard to the intended purpose of the device, the generally justification system acknowledged state of the art and best practice, must ensure that the data that influences the performance of the device is: (a) representative; and 12.1(6) (b) of sufficient quality; and ☐ ☐ List here the standards / Include direct reference to documents (cont.) Provide Justification procedures applied with within the manufacturer’s quality justification system 12.1(6) (c) maintained to ensure integrity; and ☐ ☐ List here the standards / Include direct reference to documents (cont.) Provide Justification procedures applied with within the manufacturer’s quality justification system 12.1(6) (d) managed to reduce bias. ☐ ☐ List here the standards / Include direct reference to documents (cont.) Provide Justification procedures applied with within the manufacturer’s quality justification system 12.2 Safety dependent on internal power supply ☐ ☐ List here the standards / Include direct reference to documents (1) This clause applies in relation to a medical device if the Provide Justification procedures applied with within the manufacturer’s quality justification system safety of a patient on whom the device is to be used will depend on an internal power supply for the device. 12.2 (cont.) (2) The device must be fitted with a means of determining the ☐ ☐ List here the standards / Include direct reference to documents state of the power supply. Provide Justification procedures applied with within the manufacturer’s quality justification system Part 2. Applicable Not applicable Medical Devices / IVD Evidence of compliance Justification must be standard or other Include direct reference to PRINCIPLES ABOUT DESIGN AND CONSTRUCTION provided below procedure applied documents within the manufacturer’s quality system 12 Medical devices connected to or equipped with an energy source 12.3 Safety dependent on external power supply ☐ ☐ List here the standards / Include direct reference to documents (1) This clause applies in relation to a medical device if the Provide Justification procedures applied with within the manufacturer’s quality justification system Medical Devices Essential Principles Checklist ANARME, IP Page 21 of 47

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safety of a patient on whom the device is to be used will depend on an external power supply for the device. 12.3 (cont.) (2) The device must be fitted with an alarm system that ☐ ☐ List here the standards / Include direct reference to documents indicates whether a power failure has occurred. Provide Justification procedures applied with within the manufacturer’s quality justification system 12.4 Medical devices intended to monitor clinical ☐ ☐ List here the standards / Include direct reference to documents parameters Provide Justification procedures applied with within the manufacturer’s quality A medical device that is intended by the manufacturer to be justification system used to monitor one or more clinical parameters of a patient must be fitted with an appropriate alarm system to warn the user if a situation has developed that could lead to the death of the patient or a severe deterioration in the state of the patient’s health. 12.5 Minimisation of risk of electromagnetic fields ☐ ☐ List here the standards / Include direct reference to documents A medical device must be designed and produced in a way that Provide Justification procedures applied with within the manufacturer’s quality ensures that the risk of an electromagnetic field being created that justification system could impair the operation of other devices or equipment being used in the vicinity of the medical device is minimised. 12.6 Protection against electrical risks ☐ ☐ List here the standards / Include direct reference to documents A medical device must be designed and produced in a way that Provide Justification procedures applied with within the manufacturer’s quality ensures that, as far as possible, when the device is installed justification system correctly, and the device is being used for an intended purpose under normal conditions of use and in the event of a single fault condition, patients, users, and any other persons, are protected against the risk of accidental electric shock. Part 2. Applicable Not applicable Medical Devices / IVD Evidence of compliance Justification must be standard or other Include direct reference to PRINCIPLES ABOUT DESIGN AND CONSTRUCTION provided below procedure applied documents within the manufacturer’s quality system 12 Medical devices connected to or equipped with an energy source Medical Devices Essential Principles Checklist ANARME, IP Page 22 of 47

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12.7 Protection against mechanical risks ☐ ☐ List here the standards / Include direct reference to documents A medical device must be designed and produced in a way that Provide Justification procedures applied with within the manufacturer’s quality ensures that a patient, the users and any other person, is justification system protected against any mechanical risks associated with the use of the device. 12.8 Protection against risks associated with vibration ☐ ☐ List here the standards / Include direct reference to documents (1) A medical device must be designed and produced in a way that Provide Justification procedures applied with within the manufacturer’s quality justification system ensures that any risks associated with vibrations generated by the device are minimised. 12.8 (cont.) (2) If vibrations are not part of the intended performance of the ☐ ☐ List here the standards / Include direct reference to documents device, particular attention must be given to relevant technical Provide Justification procedures applied with within the manufacturer’s quality progress, and the available means, for limiting vibrations, justification system particularly at source. 12.9 Protection against risks associated with noise ☐ ☐ List here the standards / Include direct reference to documents (1) A medical device must be designed and produced in a way that Provide Justification procedures applied with within the manufacturer’s quality justification system ensures that any risks associated with noise emitted by the device are minimised. 12.9 (cont.) (2) If noise is not part of the intended performance of the ☐ ☐ List here the standards / Include direct reference to documents device, particular attention must be given to relevant Provide Justification procedures applied with within the manufacturer’s quality technical progress, and the available means, for reducing the justification system emission of noise, particularly at source. 12.10 Protection against risks associated with terminals and ☐ ☐ List here the standards / Include direct reference to documents connectors Provide Justification procedures applied with within the manufacturer’s quality A medical device that is intended by the manufacturer to be justification system connected to an electric, gas, hydraulic, pneumatic or other energy supply must be designed and produced in a way that ensures that any risks to the user associated with the handling of a terminal or connector on the device, in relation to the energy supply, are minimised. Part 2. Applicable Not applicable Medical Devices / IVD Evidence of compliance Justification must be standard or other Include direct reference to PRINCIPLES ABOUT DESIGN AND CONSTRUCTION Medical Devices Essential Principles Checklist ANARME, IP Page 23 of 47

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12 Medical devices connected to or equipped provided below procedure applied documents within the manufacturer’s quality system with an energy source 12.11 Protection against risks associated with heat ☐ ☐ List here the standards / Include direct reference to documents A medical device must be designed and produced in a way that Provide Justification procedures applied with within the manufacturer’s quality ensures that, during normal use, any accessible part of the justification system device (other than any part intended by the manufacturer to supply heat or reach a given temperature), and any area surrounding an accessible part of the device, does not reach a potentially dangerous temperature. 12.12 Protection against risks associated with administration ☐ ☐ List here the standards / Include direct reference to documents of energy or substances Provide Justification procedures applied with within the manufacturer’s quality (1) This clause applies in relation to a medical device that is justification system intended by the manufacturer to be used to administer energy or a substance to a patient. 12.12 (2) The device must be designed and produced in a way that ☐ ☐ List here the standards / Include direct reference to documents (cont.) ensures that: Provide Justification procedures applied with within the manufacturer’s quality justification system (a) the delivered rate and amount of energy, or of the substance, can be set and maintained accurately to ensure the safety of the patient and the user; and 12.12(2) (b) as far as possible, the accidental release of ☐ ☐ List here the standards / Include direct reference to documents (cont.) dangerous levels of energy or of the substance is Provide Justification procedures applied with within the manufacturer’s quality prevented. justification system 12.12 (3) The device must be fitted with a means of indicating or, if ☐ ☐ List here the standards / Include direct reference to documents (cont.) appropriate, preventing inadequacies in the rate and Provide Justification procedures applied with within the manufacturer’s quality amount of energy, or of the substance, administered that justification system might cause danger to the patient, the user or any other person. 12.12 (4) The functions of each control and indicator on the device ☐ ☐ List here the standards / Include direct reference to documents (cont.) must be clearly specified on the device. Provide Justification procedures applied with within the manufacturer’s quality justification system Medical Devices Essential Principles Checklist ANARME, IP Page 24 of 47

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Part 2. Applicable Not applicable Medical Devices / IVD Evidence of compliance Justification must be standard or other Include direct reference to PRINCIPLES ABOUT DESIGN AND CONSTRUCTION provided below procedure applied documents within the manufacturer’s quality system 12 Medical devices connected to or equipped with an energy source 12.12 (5) If the instructions for the operation of the device, or the ☐ ☐ List here the standards / Include direct reference to documents (cont.) operating or adjustment parameters for the device, are Provide Justification procedures applied with within the manufacturer’s quality displayed by means of a visual system incorporated into the justification system device, the instructions or parameters must be able to be understood by the user and, if appropriate, the patient. 12.13 Active implantable medical devices ☐ ☐ List here the standards / Include direct reference to documents (1) An active implantable medical device must incorporate, Provide Justification procedures applied with within the manufacturer’s quality justification system display, emit or exhibit a code or unique characteristic that can be used to identify: (a) the type of device; and 12.13(1) (b) the manufacturer of the device; and ☐ ☐ List here the standards / Include direct reference to documents (cont.) Provide Justification procedures applied with within the manufacturer’s quality justification system 12.13(1) (c) the year of manufacture of the device. ☐ ☐ List here the standards / Include direct reference to documents (cont.) Provide Justification procedures applied with within the manufacturer’s quality justification system 12.13 (2) The code or unique characteristic must be able to be read ☐ ☐ List here the standards / Include direct reference to documents (cont.) without the need for surgery to the person in whom the Provide Justification procedures applied with within the manufacturer’s quality device is implanted. justification system Medical Devices Essential Principles Checklist ANARME, IP Page 25 of 47

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EP 13: Information to be provided with medical devices Part 2. Applicable Not applicable Medical Devices / IVD Evidence of compliance Justification must be standard or other Include direct reference to documents PRINCIPLES ABOUT DESIGN AND CONSTRUCTION provided below procedure applied within the manufacturer’s quality system 13 Information to be provided with medical devices 13.1 Information to be provided with medical devices— ☐ ☐ List here the standards / Include direct reference to documents general Provide Justification procedures applied with within the manufacturer’s quality (1) The following information must be provided with a medical justification system device: (a) information identifying the device; 13.1(1) (b) information identifying the manufacturer of the device; ☐ ☐ List here the standards / Include direct reference to documents (cont.) Provide Justification procedures applied with within the manufacturer’s quality justification system 13.1(1) (c) information explaining how to use the device safely ☐ ☐ List here the standards / Include direct reference to documents (cont.) having regard to the training and knowledge of potential users Provide Justification procedures applied with within the manufacturer’s quality justification system of the device. 13.1 (2) In particular ☐ ☐ List here the standards / Include direct reference to documents (cont.) (a) the information required by clause 13.3 must be Provide Justification procedures applied with within the manufacturer’s quality justification system provided with a medical device; and (b) if instructions for use of the device are required under subclause 13.4, the information mentioned in subclause 13.4(3) must be provided in those instructions. 13.1 (3) The information: ☐ ☐ List here the standards / Include direct reference to documents (cont.) (a) must be provided in English; and Provide Justification procedures applied with within the manufacturer’s quality justification system (b) may also be provided in any other language. 13.1 (4) The format, content and location of the information must be ☐ ☐ List here the standards / Include direct reference to documents (cont.) appropriate for the device and its intended purpose. Provide Justification procedures applied with within the manufacturer’s quality justification system 13.1 (5) Any number, letter, symbol, or letter or number in a symbol, ☐ ☐ List here the standards / Include direct reference to documents (cont.) Medical Devices Essential Principles Checklist ANARME, IP Page 26 of 47

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used in the information must be legible and at least Provide Justification procedures applied with within the manufacturer’s quality 1 millimetre high. justification system Part 2. Applicable Not applicable Medical Devices / IVD Evidence of compliance Justification must be standard or other Include direct reference to documents PRINCIPLES ABOUT DESIGN AND CONSTRUCTION provided below procedure applied within the manufacturer’s quality system 13 Information to be provided with medical devices 13.1 (6) If a symbol or identification colour that is not included in a ☐ ☐ List here the standards / Include direct reference to documents (cont.) medical device standard is used in the information provided with Provide Justification procedures applied with within the manufacturer’s quality the device, or in the instructions for use of the device, the justification system meaning of the symbol or identification colour must be explained in the information provided with the device or the instructions for use of the device. 13.2 Information to be provided with medical devices— ☐ ☐ List here the standards / Include direct reference to documents location Provide Justification procedures applied with within the manufacturer’s quality (1) Unless it is impracticable or inappropriate to do so, the justification system information required to be provided with a medical device must be provided on the device itself. 13.2 (2) If it is not practicable to comply with subclause (1) in ☐ ☐ List here the standards / Include direct reference to documents (cont.) relation to the provision of the information, the information Provide Justification procedures applied with within the manufacturer’s quality must be provided: justification system (a) on the packaging used for the device; or 13.2(2) (b) in the case of devices that are packaged together ☐ ☐ List here the standards / Include direct reference to documents (cont.) because individual packaging of the devices for supply is Provide Justification procedures applied with within the manufacturer’s quality not practicable—on the outer packaging used for the justification system devices. 13.2 (3) If it is not practicable to comply with subclause (1) or (2) in ☐ ☐ List here the standards / Include direct reference to documents (cont.) relation to the provision of the information Provide Justification procedures applied with within the manufacturer’s quality justification system 13.2(3) (a) for a medical device that is not software—the ☐ ☐ List here the standards / Include direct reference to documents (cont.) information must be provided on a leaflet supplied with Provide Justification procedures applied with within the manufacturer’s quality the device; or justification system Medical Devices Essential Principles Checklist ANARME, IP Page 27 of 47

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13.2(3) (b) for a medical device that is software—the information ☐ ☐ List here the standards / Include direct reference to documents (cont.) must be provided on a leaflet supplied with the device or Provide Justification procedures applied with within the manufacturer’s quality the information must be provided electronically. justification system Part 2. Applicable Not applicable Medical Devices / IVD Evidence of compliance Justification must be standard or other Include direct reference to documents PRINCIPLES ABOUT DESIGN AND CONSTRUCTION provided below procedure applied within the manufacturer’s quality system 13 Information to be provided with medical devices 13.2 (4) If it is not practicable to comply with subclause (1) or (2) in ☐ ☐ List here the standards / Include direct reference to documents (cont.) relation to the provision of the information required under Provide Justification procedures applied with within the manufacturer’s quality clause 13.4, the information must be provided in a printed justification system document or using other appropriate media. 13.3 Information to be provided with medical devices— ☐ ☐ List here the standards / Include direct reference to documents particular requirements Provide Justification procedures applied with within the manufacturer’s quality The information mentioned in the following table must be justification system provided with a medical device. 13.3 Item Information to be provided (cont.) 13.3 1 The manufacturer’s name, or trading name, and address ☐ ☐ List here the standards / Include direct reference to documents (cont.) Provide Justification procedures applied with within the manufacturer’s quality justification system 13.3 2 The intended purpose of the device, the intended user of ☐ ☐ List here the standards / Include direct reference to documents (cont.) the device, and the kind of patient on whom the device Provide Justification procedures applied with within the manufacturer’s quality is intended to be used (if this information is not justification system obvious) 13.3 3 Sufficient information to enable a user to identify the ☐ ☐ List here the standards / Include direct reference to documents (cont.) device, or if relevant, the contents of packaging Provide Justification procedures applied with within the manufacturer’s quality justification system 13.3 4 Any particular handling or storage requirements applying ☐ ☐ List here the standards / Include direct reference to documents (cont.) to the device Provide Justification procedures applied with within the manufacturer’s quality justification system Medical Devices Essential Principles Checklist ANARME, IP Page 28 of 47

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13.3 5 Any warnings, restrictions, or precautions that should ☐ ☐ List here the standards / Include direct reference to documents (cont.) be taken, in relation to use of the device Provide Justification procedures applied with within the manufacturer’s quality justification system 13.3 6 Any special operating instructions for the use of the ☐ ☐ List here the standards / Include direct reference to documents (cont.) device Provide Justification procedures applied with within the manufacturer’s quality justification system 13.3 7 If applicable, an indication that the device is intended for a ☐ ☐ List here the standards / Include direct reference to documents (cont.) single use only Provide Justification procedures applied with within the manufacturer’s quality justification system Part 2. Applicable Not applicable Medical Devices / IVD Evidence of compliance Justification must be standard or other Include direct reference to documents PRINCIPLES ABOUT DESIGN AND CONSTRUCTION provided below procedure applied within the manufacturer’s quality system 13 Information to be provided with medical devices 13.3 8 If applicable, an indication that the device has been ☐ ☐ List here the standards / Include direct reference to documents (cont.) custom-made for a particular individual or health Provide Justification procedures applied with within the manufacturer’s quality professional and is intended for use only by that justification system individual or health professional 13.3 9 If applicable, an indication that: ☐ ☐ List here the standards / Include direct reference to documents (cont.) (a) if the device is a medical device other than an Provide Justification procedures applied with within the manufacturer’s quality justification system IVD medical device—the device is intended for pre- market clinical investigation; or 13.3 Item (b) if the device is an IVD medical device—the ☐ ☐ List here the standards / Include direct reference to documents 9 (cont.) device is intended for performance evaluation only Provide Justification procedures applied with within the manufacturer’s quality justification system 13.3 10 For a sterile device, the word ‘STERILE’ and ☐ ☐ List here the standards / Include direct reference to documents (cont.) information about the method that was used to sterilise Provide Justification procedures applied with within the manufacturer’s quality the device justification system 13.3 11 The batch code, lot number or serial number of the device ☐ ☐ List here the standards / Include direct reference to documents (cont.) Provide Justification procedures applied with within the manufacturer’s quality justification system 13.3 12 If applicable, a statement of the date (expressed in a way ☐ ☐ List here the standards / Include direct reference to documents (cont.) that clearly identifies the month and year) up to when the Provide Justification procedures applied with within the manufacturer’s quality Medical Devices Essential Principles Checklist ANARME, IP Page 29 of 47

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device can be safely used justification system 13.3 13 If the information provided with the device does not ☐ ☐ List here the standards / Include direct reference to documents (cont.) include the information mentioned in item 12—a Provide Justification procedures applied with within the manufacturer’s quality statement of the date of manufacture of the device (this justification system may be included in the batch code, lot number or serial number of the device, provided the date is clearly identifiable) 13.3 14 If applicable, the words ‘for export only’ ☐ ☐ List here the standards / Include direct reference to documents (cont.) Provide Justification procedures applied with within the manufacturer’s quality justification system Part 2. Applicable Not applicable Medical Devices / IVD Evidence of compliance Justification must be standard or other Include direct reference to documents PRINCIPLES ABOUT DESIGN AND CONSTRUCTION provided below procedure applied within the manufacturer’s quality system 13 Information to be provided with medical devices 13.4 Instructions for use ☐ ☐ List here the standards / Include direct reference to documents (1) Instructions for the use of a medical device must be provided Provide Justification procedures applied with within the manufacturer’s quality justification system with the device. 13.4 (2) However, instructions for the use of a medical device need not ☐ ☐ List here the standards / Include direct reference to documents (cont.) be provided with the device, or may be abbreviated, if: Provide Justification procedures applied with within the manufacturer’s quality justification system (a) the device is a Class I medical device, a Class IIa medical device or a Class 1 IVD medical device; and 13.4(2) (b) the device can be used safely for its intended purpose ☐ ☐ List here the standards / Include direct reference to documents (cont.) without instructions. Provide Justification procedures applied with within the manufacturer’s quality justification system 13.4 (3) Instructions for the use of a medical device must include ☐ ☐ List here the standards / Include direct reference to documents (cont.) information mentioned in the following table that is Provide Justification procedures applied with within the manufacturer’s quality applicable to the device. justification system 13.4 Item Information to be provided (cont.) 13.4 1 The manufacturer’s name, or trading name, and address ☐ ☐ List here the standards / Include direct reference to documents (cont.) Provide Justification procedures applied with within the manufacturer’s quality justification system Medical Devices Essential Principles Checklist ANARME, IP Page 30 of 47

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13.4 2 The intended purpose of the device, the intended user ☐ ☐ List here the standards / Include direct reference to documents (cont.) of the device, and the kind of patient on whom the Provide Justification procedures applied with within the manufacturer’s quality device is intended to be used justification system Medical Devices Essential Principles Checklist ANARME, IP Page 31 of 47

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Part 2. Applicable Not applicable Medical Devices / IVD Evidence of compliance Justification must be standard or other Include direct reference to documents PRINCIPLES ABOUT DESIGN AND CONSTRUCTION provided below procedure applied within the manufacturer’s quality system 13 Information to be provided with medical devices 13.4 3 Information about any risk arising because of other ☐ ☐ List here the standards / Include direct reference to documents (cont.) equipment likely to be present when the device is Provide Justification procedures applied with within the manufacturer’s quality being used for its intended purpose (for example, justification system electrical interference from electro-surgical devices or magnetic field interference from magnetic resonance imaging devices) 13.4 4 Information about the intended performance of the ☐ ☐ List here the standards / Include direct reference to documents (cont.) device and any undesirable side effects caused by use of Provide Justification procedures applied with within the manufacturer’s quality the device justification system 13.4 5 Any contra-indications, warnings, restrictions, or ☐ ☐ List here the standards / Include direct reference to documents (cont.) precautions that may apply in relation to use of the device Provide Justification procedures applied with within the manufacturer’s quality justification system 13.4 6 Sufficient information to enable a user to identify the ☐ ☐ List here the standards / Include direct reference to documents (cont.) device, or if relevant, the contents of packaging Provide Justification procedures applied with within the manufacturer’s quality justification system 13.4 7 Any particular handling or storage requirements applying ☐ ☐ List here the standards / Include direct reference to documents (cont.) to the device Provide Justification procedures applied with within the manufacturer’s quality justification system 13.4 8 If applicable, an indication that the device is intended ☐ ☐ List here the standards / Include direct reference to documents (cont.) for a single use only Provide Justification procedures applied with within the manufacturer’s quality justification system 13.4 9 If applicable, an indication that the device has been ☐ ☐ List here the standards / Include direct reference to documents (cont.) custom-made for a particular individual or health Provide Justification procedures applied with within the manufacturer’s quality professional and is intended for use only by that justification system individual or health professional 13.4 10 If applicable, an indication that: ☐ ☐ List here the standards / Include direct reference to documents (cont.) (a) if the device is a medical device other than an Provide Justification procedures applied with within the manufacturer’s quality justification system IVD medical device—the device is intended for pre-market clinical investigation; or 13.4 item (b) if the device is an IVD medical device—the device ☐ ☐ List here the standards / Include direct reference to documents 10 (cont.) Medical Devices Essential Principles Checklist ANARME, IP Page 32 of 47

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is intended for performance evaluation only Provide Justification procedures applied with within the manufacturer’s quality justification system Part 2. Applicable Not applicable Medical Devices / IVD Evidence of compliance Justification must be standard or other Include direct reference to documents PRINCIPLES ABOUT DESIGN AND CONSTRUCTION provided below procedure applied within the manufacturer’s quality system 13 Information to be provided with medical devices 13.4 11 For a sterile device, the word ‘STERILE’ and ☐ ☐ List here the standards / Include direct reference to documents (cont.) information about the method that was used to sterilise Provide Justification procedures applied with within the manufacturer’s quality the device justification system 13.4 12 For a device that is intended by the manufacturer to be ☐ ☐ List here the standards / Include direct reference to documents (cont.) supplied in a sterile state: Provide Justification procedures applied with within the manufacturer’s quality (a) an indication that the device is sterile; and justification system 13.4 Item (b) information about what to do if sterile ☐ ☐ List here the standards / Include direct reference to documents 12 (cont.) packaging is damaged; and Provide Justification procedures applied with within the manufacturer’s quality justification system 13.4 item (c) if appropriate, instructions for re-sterilisation of the ☐ ☐ List here the standards / Include direct reference to documents 12 (cont.) device Provide Justification procedures applied with within the manufacturer’s quality justification system 13.4 13 For a medical device that is intended by the ☐ ☐ List here the standards / Include direct reference to documents (cont.) manufacturer to be sterilised before use— instructions Provide Justification procedures applied with within the manufacturer’s quality for cleaning and sterilising the device which, if followed, justification system will ensure that the device continues to comply with the applicable provisions of the Essential Principles 13.4 14 Any special operating instructions for the use of the ☐ ☐ List here the standards / Include direct reference to documents (cont.) device Provide Justification procedures applied with within the manufacturer’s quality justification system 13.4 15 Information to enable the user to verify whether the ☐ ☐ List here the standards / Include direct reference to documents (cont.) device is properly installed and whether it can be Provide Justification procedures applied with within the manufacturer’s quality operated safely and correctly, including details of justification system calibration (if any) needed to ensure that the device operates properly and safely during its intended life 13.4 16 Information about the nature and frequency of regular ☐ ☐ List here the standards / Include direct reference to documents (cont.) and preventative maintenance of the device, including Provide Justification procedures applied with within the manufacturer’s quality information about the replacement of consumable justification system Medical Devices Essential Principles Checklist ANARME, IP Page 33 of 47

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components of the device during its intended life Part 2. Applicable Not applicable Medical Devices / IVD Evidence of compliance Justification must be standard or other Include direct reference to documents PRINCIPLES ABOUT DESIGN AND CONSTRUCTION provided below procedure applied within the manufacturer’s quality system 13 Information to be provided with medical devices 13.4 17 Information about any treatment or handling needed ☐ ☐ List here the standards / Include direct reference to documents (cont.) before the device can be used Provide Justification procedures applied with within the manufacturer’s quality justification system 13.4 18 For a device that is intended by the manufacturer to be ☐ ☐ List here the standards / Include direct reference to documents (cont.) installed with, or connected to, another medical device Provide Justification procedures applied with within the manufacturer’s quality or other equipment so that the device can operate as justification system required for its intended purpose— sufficient information about the device to enable the user to identify the appropriate other medical device or equipment that will ensure a safe combination 13.4 19 For an implantable medical device—information about ☐ ☐ List here the standards / Include direct reference to documents (cont.) any risks associated with its implantation Provide Justification procedures applied with within the manufacturer’s quality justification system 13.4 20 For a reusable device: ☐ ☐ List here the standards / Include direct reference to documents (cont.) (a) information about the appropriate processes to Provide Justification procedures applied with within the manufacturer’s quality justification system allow reuse of the device (including information about cleaning, disinfection, packaging and, if appropriate, re-sterilisation of the device); and 13.4 item (b) an indication of the number of times the device ☐ ☐ List here the standards / Include direct reference to documents 20 (cont.) may be safely reused Provide Justification procedures applied with within the manufacturer’s quality justification system 13.4 21 For a medical device that is intended by the ☐ ☐ List here the standards / Include direct reference to documents (cont.) manufacturer to emit radiation for medical purposes— Provide Justification procedures applied with within the manufacturer’s quality details of the nature, type, intensity and distribution of justification system the radiation emitted 13.4 22 Information about precautions that should be taken by ☐ ☐ List here the standards / Include direct reference to documents (cont.) a patient and the user if the performance of the device Provide Justification procedures applied with within the manufacturer’s quality changes justification system Medical Devices Essential Principles Checklist ANARME, IP Page 34 of 47

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Part 2. Applicable Not applicable Medical Devices / IVD Evidence of compliance Justification must be standard or other Include direct reference to documents PRINCIPLES ABOUT DESIGN AND CONSTRUCTION provided below procedure applied within the manufacturer’s quality system 13 Information to be provided with medical devices 13.4 23 Information about precautions that should be taken by ☐ ☐ List here the standards / Include direct reference to documents (cont.) a patient and the user if it is reasonably foreseeable Provide Justification procedures applied with within the manufacturer’s quality that use of the device will result in the patient or user justification system being exposed to adverse environmental conditions 13.4 24 Adequate information about any medicinal product ☐ ☐ List here the standards / Include direct reference to documents (cont.) that the device is designed to administer, including any Provide Justification procedures applied with within the manufacturer’s quality limitations on the substances that may be administered justification system using the device 13.4 25 Information about any medicine (including any stable ☐ ☐ List here the standards / Include direct reference to documents (cont.) derivative of human blood or blood plasma) that is Provide Justification procedures applied with within the manufacturer’s quality incorporated, or is intended to be incorporated, into justification system the device as an integral part of the device 13.4 25A For a medical device, other than an IVD medical device, ☐ ☐ List here the standards / Include direct reference to documents (cont.) information about any tissues, tissue derivatives, cells or Provide Justification procedures applied with within the manufacturer’s quality substances of animal origin that have been rendered justification system non-viable, or tissues, cells or substances of microbial or recombinant origin that are included in the device 13.4 26 Information about precautions that should be taken by ☐ ☐ List here the standards / Include direct reference to documents (cont.) a patient and the user if there are special or unusual Provide Justification procedures applied with within the manufacturer’s quality risks associated with the disposal of the device justification system 13.4 27 Information about the degree of accuracy claimed if the ☐ ☐ List here the standards / Include direct reference to documents (cont.) device has a measuring function Provide Justification procedures applied with within the manufacturer’s quality justification system 13.4 28 Information about any particular facilities required for ☐ ☐ List here the standards / Include direct reference to documents (cont.) use of the device or any particular training or Provide Justification procedures applied with within the manufacturer’s quality qualifications required by the user of the device justification system Part 2. Applicable Not applicable Medical Devices / IVD Evidence of compliance Medical Devices Essential Principles Checklist ANARME, IP Page 35 of 47

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PRINCIPLES ABOUT DESIGN AND CONSTRUCTION Justification must be standard or other Include direct reference to documents provided below within the manufacturer’s quality procedure applied system 13 Information to be provided with medical devices 13.4 29 For an IVD medical device, information (including, to ☐ ☐ List here the standards / Include direct reference to documents (cont.) the extent practicable, drawings and diagrams) about Provide Justification procedures applied with within the manufacturer’s quality the following: justification system (a) the scientific principle (the ‘test principle’) on which the performance of the IVD medical device relies; 13.4 item (b) specimen type, collection, handling and ☐ ☐ List here the standards / Include direct reference to documents 29 (cont.) preparation; Provide Justification procedures applied with within the manufacturer’s quality justification system 13.4 item (c) reagent description and any limitations (for ☐ ☐ List here the standards / Include direct reference to documents 29 (cont.) example, use with a dedicated instrument Provide Justification procedures applied with within the manufacturer’s quality only); justification system 13.4 item (d) assay procedure including calculations and ☐ ☐ List here the standards / Include direct reference to documents 29 (cont.) interpretation of results; Provide Justification procedures applied with within the manufacturer’s quality justification system 13.4 item (e) interfering substances and their effect on the ☐ ☐ List here the standards / Include direct reference to documents 29 (cont.) performance of the assay; Provide Justification procedures applied with within the manufacturer’s quality justification system 13.4 item (f) analytical performance characteristics, such as ☐ ☐ List here the standards / Include direct reference to documents 29 (cont.) sensitivity, specificity, accuracy and Provide Justification procedures applied with within the manufacturer’s quality precision; justification system 13.4 item (g) clinical performance characteristics, such as ☐ ☐ List here the standards / Include direct reference to documents 29 (cont.) sensitivity and specificity; Provide Justification procedures applied with within the manufacturer’s quality justification system 13.4 item (h) reference intervals, if appropriate; ☐ ☐ List here the standards / Include direct reference to documents 29 (cont.) Provide Justification procedures applied with within the manufacturer’s quality justification system 13.4 item (i) any precautions to be taken in relation to ☐ ☐ List here the standards / Include direct reference to documents 29 (cont.) substances or materials that present a risk of Provide Justification procedures applied with within the manufacturer’s quality infection justification system Medical Devices Essential Principles Checklist ANARME, IP Page 36 of 47

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Part 2. Applicable Not applicable Medical Devices / IVD Evidence of compliance Justification must be standard or other Include direct reference to documents PRINCIPLES ABOUT DESIGN AND CONSTRUCTION provided below procedure applied within the manufacturer’s quality system 13 Information to be provided with medical devices 13.4 30 For an adaptable medical device, instructions for ☐ ☐ List here the standards / Include direct reference to documents (cont.) assembling or adapting the device which, if followed, Provide Justification procedures applied with within the manufacturer’s quality will ensure that the device continues to comply with justification system the applicable provisions of the Essential Principles 13.4 31 For a medical device production system, instructions for ☐ ☐ List here the standards / Include direct reference to documents (cont.) the process to be followed in producing the medical Provide Justification procedures applied with within the manufacturer’s quality device the system is intended to produce which, if justification system followed, will ensure that the device so produced will comply with the applicable provisions of the Essential Principles EP 13A: Patient information about implantable medical devices or active implantable medical devices to be made available Part 2. Applicable Not applicable Medical Devices / IVD Evidence of compliance Justification must be standard or other Include direct reference to documents PRINCIPLES ABOUT DESIGN AND CONSTRUCTION provided below procedure applied within the manufacturer’s quality system 13A Patient information about implantable medical devices or active implantable medical devices to be made available 13A.1 Scope of clauses 13A.2 to 13A.4 ☐ ☐ List here the standards / Include direct reference to documents (1) Clauses 13A.2 to 13A.4 apply to a medical device that is: Provide Justification procedures applied with within the manufacturer’s quality justification system (a) an implantable medical device or an active implantable medical device; and 13A.1(1) (b) not a suture, staple, dental filling, dental brace, tooth crown, ☐ ☐ List here the standards / Include direct reference to documents (cont.) screw, wedge, plate, wire, pin, clip, connector or similar article; Provide Justification procedures applied with within the manufacturer’s quality justification system Medical Devices Essential Principles Checklist ANARME, IP Page 37 of 47

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and Part 2. Applicable Not applicable Medical Devices / IVD Evidence of compliance Justification must be standard or other Include direct reference to documents PRINCIPLES ABOUT DESIGN AND CONSTRUCTION provided below procedure applied within the manufacturer’s quality system 13A Patient information about implantable medical devices or active implantable medical devices to be made available 13A.1(1) (c) (ba) not intended by the manufacturer to be for ☐ ☐ List here the standards / Include direct reference to documents (cont.) export only; and Provide Justification procedures applied with within the manufacturer’s quality justification system 13A.1(1) (d) not a medical device to which subclause (2) applies. ☐ ☐ List here the standards / Include direct reference to documents (cont.) Provide Justification procedures applied with within the manufacturer’s quality justification system 13A.1 (2) This subclause applies to a medical device if: ☐ ☐ List here the standards / Include direct reference to documents (cont.) (a) the medical device is intended by the manufacturer to be Provide Justification procedures applied with within the manufacturer’s quality justification system wholly, or mostly, absorbed by a patient’s body within 6 months of being implanted; and 13A.1(2) (b) the medical device is: ☐ ☐ List here the standards / Include direct reference to documents (cont.) (i) for use as a filler; or Provide Justification procedures applied with within the manufacturer’s quality justification system 13A.1(2) (ii) for haemostasis; or ☐ ☐ List here the standards / Include direct reference to documents (cont.) Provide Justification procedures applied with within the manufacturer’s quality justification system 13A.1(2) (iii) for tissue approximation; or ☐ ☐ List here the standards / Include direct reference to documents (cont.) Provide Justification procedures applied with within the manufacturer’s quality justification system 13A.1(2) (iv) for the fixation of other medical devices within ☐ ☐ List here the standards / Include direct reference to documents (cont.) tissue; or Provide Justification procedures applied with within the manufacturer’s quality justification system 13A.1(2) (v) a similar medical device to a medical device ☐ ☐ List here the standards / Include direct reference to documents (cont.) covered by subparagraph (i), (ii), (iii) or (iv). Provide Justification procedures applied with within the manufacturer’s quality justification system Medical Devices Essential Principles Checklist ANARME, IP Page 38 of 47

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Part 2. Applicable Not applicable Medical Devices / IVD Evidence of compliance Justification must be standard or other Include direct reference to documents PRINCIPLES ABOUT DESIGN AND CONSTRUCTION provided below procedure applied within the manufacturer’s quality system 13A Patient information about implantable medical devices or active implantable medical devices to be made available 13A.2 Patient implant cards etc. for implantable devices ☐ ☐ List here the standards / Include direct reference to documents (1) Either: Provide Justification procedures applied with within the manufacturer’s quality justification system (a) a card (a patient implant card) that includes the information covered by subclause (2) and that satisfies clause 13A.4 must be made available for provision to the patient concerned; or 13A.2(1) (b) information covered by subclause (2) that is in electronic ☐ ☐ List here the standards / Include direct reference to documents (cont.) form and that satisfies clause 13A.4 must be made Provide Justification procedures applied with within the manufacturer’s quality available in a way that is readily accessible by the patient justification system concerned. 13A.2 (2) The information covered by this subclause is the information in ☐ ☐ List here the standards / Include direct reference to documents (cont.) the following table. Provide Justification procedures applied with within the manufacturer’s quality justification system 13A.2(2) (cont.) Item Information to be provided 13A.2(2) 1 (a) the name of the device; and ☐ ☐ List here the standards / Include direct reference to documents (cont.) Provide Justification procedures applied with within the manufacturer’s quality justification system 13A.2(2) (cont.) (b) the model of the device; and ☐ ☐ List here the standards / Include direct reference to documents Item 1 (cont.) Provide Justification procedures applied with within the manufacturer’s quality justification system 13A.2(2) (cont.) (c) the batch code, lot number or serial number of the ☐ ☐ List here the standards / Include direct reference to documents item 1 (cont.) device Provide Justification procedures applied with within the manufacturer’s quality justification system 13A.2 2 The manufacturer’s name, address and website ☐ ☐ List here the standards / Include direct reference to documents (cont.) Medical Devices Essential Principles Checklist ANARME, IP Page 39 of 47

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Provide Justification procedures applied with within the manufacturer’s quality justification system Part 2. Applicable Not applicable Medical Devices / IVD Evidence of compliance Justification must be standard or other Include direct reference to documents PRINCIPLES ABOUT DESIGN AND CONSTRUCTION provided below procedure applied within the manufacturer’s quality system 13A Patient information about implantable medical devices or active implantable medical devices to be made available 13A.3 Patient information leaflets etc. for implantable devices ☐ ☐ List here the standards / Include direct reference to documents (1) Either: Provide Justification procedures applied with within the manufacturer’s quality justification system (a) a leaflet (a patient information leaflet) that includes the information covered by subclauses (2) and (3) and that satisfies subclause (4) and clause 13A.4 must be made available for provision to the patient concerned; or 13A.3(1) (b) information covered by subclauses (2) and (3) that is in ☐ ☐ List here the standards / Include direct reference to documents (cont.) electronic form and that satisfies subclause (4) and clause Provide Justification procedures applied with within the manufacturer’s quality 13A.4 must be made available in a way that is readily justification system accessible by the patient concerned. 13A.3 (2) The information covered by this subclause is the following ☐ ☐ List here the standards / Include direct reference to documents (cont.) information: Provide Justification procedures applied with within the manufacturer’s quality justification system (a) information identifying the device, or the kind of device; 13A.3(2) (b) the intended purpose of the device; ☐ ☐ List here the standards / Include direct reference to documents (cont.) Provide Justification procedures applied with within the manufacturer’s quality justification system 13A.3(2) (c) information explaining how to use the device safely; ☐ ☐ List here the standards / Include direct reference to documents (cont.) Provide Justification procedures applied with within the manufacturer’s quality justification system 13A.3(2) (d) other information about the device that the manufacturer ☐ ☐ List here the standards / Include direct reference to documents (cont.) considers would be useful for patients. Provide Justification procedures applied with within the manufacturer’s quality justification system Medical Devices Essential Principles Checklist ANARME, IP Page 40 of 47

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13A.3 (3) The information covered by this subclause is the information in ☐ ☐ List here the standards / Include direct reference to documents (cont.) the following table. Provide Justification procedures applied with within the manufacturer’s quality justification system 13A.3(3) (cont.) Item Information to be provided 13A.3(3) 1 (a) the name of the device; and ☐ ☐ List here the standards / Include direct reference to documents (cont.) Provide Justification procedures applied with within the manufacturer’s quality justification system Part 2. Applicable Not applicable Medical Devices / IVD Evidence of compliance Justification must be standard or other Include direct reference to documents PRINCIPLES ABOUT DESIGN AND CONSTRUCTION provided below procedure applied within the manufacturer’s quality system 13A Patient information about implantable medical devices or active implantable medical devices to be made available 13A.3(3) (cont.) (b) the model of the device ☐ ☐ List here the standards / Include direct reference to documents (cont.) Provide Justification procedures applied with within the manufacturer’s quality justification system 13A.3(3) 2 (a) the intended purpose of the device; and ☐ ☐ List here the standards / Include direct reference to documents (cont.) Provide Justification procedures applied with within the manufacturer’s quality justification system 13A.3(3) (cont.) (b) the kind of patient on whom the device is ☐ ☐ List here the standards / Include direct reference to documents (cont.) intended to be used Provide Justification procedures applied with within the manufacturer’s quality justification system 13A.3(3) 3 Any special operating instructions for the use of the ☐ ☐ List here the standards / Include direct reference to documents (cont.) device Provide Justification procedures applied with within the manufacturer’s quality justification system 13A.3(3) 4 (a) the intended performance of the device; and ☐ ☐ List here the standards / Include direct reference to documents (cont.) Provide Justification procedures applied with within the manufacturer’s quality justification system 13A.3(3) (cont.) (b) any undesirable side effects that could be caused ☐ ☐ List here the standards / Include direct reference to documents (cont.) by use of the device Provide Justification procedures applied with within the manufacturer’s quality justification system Medical Devices Essential Principles Checklist ANARME, IP Page 41 of 47

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13A.3(3) 5 Any residual risks that could arise due to any ☐ ☐ List here the standards / Include direct reference to documents (cont.) shortcomings of the protection measures adopted as Provide Justification procedures applied with within the manufacturer’s quality mentioned in subclause 2(2) justification system 13A.3(3) 6 (a) warnings about risks that could arise from the ☐ ☐ List here the standards / Include direct reference to documents (cont.) interaction of the device with other equipment; Provide Justification procedures applied with within the manufacturer’s quality and justification system Medical Devices Essential Principles Checklist ANARME, IP Page 42 of 47

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Part 2. Applicable Not applicable Medical Devices / IVD Evidence of compliance Justification must be standard or other Include direct reference to documents PRINCIPLES ABOUT DESIGN AND CONSTRUCTION provided below procedure applied within the manufacturer’s quality system 13A Patient information about implantable medical devices or active implantable medical devices to be made available 13A.3(3) (cont.) (b) precautions and other measures that, because of ☐ ☐ List here the standards / Include direct reference to documents (cont.) those risks, should be taken by the patient or a Provide Justification procedures applied with within the manufacturer’s quality health professional justification system (c) Example 1: The risk of electrical interference from electro-surgical devices. (d) Example 2: The risk of magnetic field interference from magnetic resonance imaging devices. 13A.3(3) 7 (a) the nature and frequency of regular or ☐ ☐ List here the standards / Include direct reference to documents (cont.) preventative examination, monitoring or Provide Justification procedures applied with within the manufacturer’s quality maintenance of the device that should be justification system undertaken; and 13A.3(3) (cont.) (b) symptoms that could indicate that the device is ☐ ☐ List here the standards / Include direct reference to documents (cont.) malfunctioning; and Provide Justification procedures applied with within the manufacturer’s quality justification system 13A.3(3) (cont.) (c) precautions and other measures that should be ☐ ☐ List here the standards / Include direct reference to documents (cont.) taken by the patient if the performance of the Provide Justification procedures applied with within the manufacturer’s quality device changes or the patient experiences any of justification system the symptoms mentioned in paragraph (b); and 13A.3(3) (cont.) (d) the expected device lifetime; and ☐ ☐ List here the standards / Include direct reference to documents (cont.) Provide Justification procedures applied with within the manufacturer’s quality justification system 13A.3(3) (cont.) (e) anything that could shorten or lengthen the device ☐ ☐ List here the standards / Include direct reference to documents (cont.) lifetime; and Provide Justification procedures applied with within the manufacturer’s quality justification system 13A.3(3) (cont.) (f) precautions and other measures that should be ☐ ☐ List here the standards / Include direct reference to documents (cont.) procedures applied with within the manufacturer’s quality Medical Devices Essential Principles Checklist ANARME, IP Page 43 of 47

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taken at, or near, the end of the expected device Provide Justification justification system lifetime; and Part 2. Applicable Not applicable Medical Devices / IVD Evidence of compliance Justification must be standard or other Include direct reference to documents PRINCIPLES ABOUT DESIGN AND CONSTRUCTION provided below procedure applied within the manufacturer’s quality system 13A Patient information about implantable medical devices or active implantable medical devices to be made available 13A.3(3) (cont.) (g) other circumstances in which the patient should ☐ ☐ List here the standards / Include direct reference to documents (cont.) contact a health professional in relation to the Provide Justification procedures applied with within the manufacturer’s quality operation of the device justification system 13A.3(3) 8 (a) the materials and substances included in the ☐ ☐ List here the standards / Include direct reference to documents (cont.) device; and Provide Justification procedures applied with within the manufacturer’s quality justification system 13A.3(3) (cont.) (b) any manufacturing residuals that could pose a risk ☐ ☐ List here the standards / Include direct reference to documents (cont.) to the patient Provide Justification procedures applied with within the manufacturer’s quality justification system 13A.3(3) 9 (a) (a) a notice that any serious incident that occurs ☐ ☐ List here the standards / Include direct reference to documents (cont.) in relation to the device should be reported to Provide Justification procedures applied with within the manufacturer’s quality the manufacturer and to the ANARME, IP; and justification system 13A.3 (4) The information covered by subclauses (2) and (3) must be written ☐ ☐ List here the standards / Include direct reference to documents (cont.) in a way that is readily understood by patients. Provide Justification procedures applied with within the manufacturer’s quality justification system 13A.4 General requirements for information to be made ☐ ☐ List here the standards / Include direct reference to documents available for patients Provide Justification procedures applied with within the manufacturer’s quality (1) The information covered by subclause 13A.2(2) or 13A.3(2) or (3): justification system (a) must be included in English; and (b) may also be included in any other language. Note: The information may also include diagrams or drawings. Medical Devices Essential Principles Checklist ANARME, IP Page 44 of 47

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Part 2. Applicable Not applicable Medical Devices / IVD Evidence of compliance Justification must be standard or other Include direct reference to documents PRINCIPLES ABOUT DESIGN AND CONSTRUCTION provided below procedure applied within the manufacturer’s quality system 13A Patient information about implantable medical devices or active implantable medical devices to be made available 13A.4 (2) Any number, letter or symbol, or letter or number in a symbol, ☐ ☐ List here the standards / Include direct reference to documents (cont) that is part of the information covered by subclause 13A.2(2) or Provide Justification procedures applied with within the manufacturer’s quality 13A.3(2) or (3) must be: justification system (a) legible; and 13A.4(2) (b) if the number, letter or symbol, or letter or number in a ☐ ☐ List here the standards / Include direct reference to documents (cont) symbol, is included in a patient implant card or patient Provide Justification procedures applied with within the manufacturer’s quality information leaflet—at least 1 millimetre high. justification system EP 13B: Software—version numbers and build numbers Part 2. Applicable Not applicable Medical Devices / IVD Evidence of compliance Justification must be standard or other Include direct reference to PRINCIPLES ABOUT DESIGN AND CONSTRUCTION provided below procedure applied documents within the manufacturer’s quality system 13B Software—version numbers and build numbers 13B (1) For a medical device that is software, or that incorporates software, ☐ ☐ List here the standards / Include direct reference to documents the current version number and current build number of the Provide Justification procedures applied with within the manufacturer’s quality software must be accessible by, and identifiable to, users of the justification system device. 13B (2) The current version number and current build number of the ☐ ☐ List here the standards / Include direct reference to documents (cont.) software: Provide Justification procedures applied with within the manufacturer’s quality justification system (a) must be in English; and (b) may also be in any other language. Medical Devices Essential Principles Checklist ANARME, IP Page 45 of 47

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EP 14: Clinical evidence Part 2. Applicable Not applicable Medical Devices / IVD Evidence of compliance Justification must be standard or other Include direct reference to PRINCIPLES ABOUT DESIGN AND CONSTRUCTION provided below procedure applied documents within the manufacturer’s quality system 14 Clinical evidence 14 Every medical device requires clinical evidence, appropriate for the ☐ ☐ List here the standards / Include direct reference to documents use and classification of the device, demonstrating that the device Provide Justification procedures applied with within the manufacturer’s quality complies with the applicable provisions of the Essential Principles. justification system EP 15: Principles applying to IVD medical devices only Applicable Not applicable Medical Devices / IVD Evidence of compliance Part 2. PRINCIPLES ABOUT DESIGN AND Justification must be standard or other Include direct reference to CONSTRUCTION provided below procedure applied documents within the manufacturer’s quality system 15 Principles applying to IVD medical devices only 15 (1) An IVD medical device must be designed and manufactured in a ☐ ☐ List here the standards / Include direct reference to documents way in which the analytical and clinical characteristics support Provide Justification procedures applied with within the manufacturer’s quality the intended use, based on appropriate scientific and technical justification system methods. 15 (2) An IVD medical device must be designed in a way that ☐ ☐ List here the standards / Include direct reference to documents (cont.) addresses accuracy, precision, sensitivity, specificity, stability, Provide Justification procedures applied with within the manufacturer’s quality control of known relevant interference and measurement of justification system uncertainty, as appropriate. 15 (3) If performance of an IVD medical device depends in whole or ☐ ☐ List here the standards / Include direct reference to documents (cont.) part on the use of calibrators or control materials, the Provide Justification procedures applied with within the manufacturer’s quality traceability of values assigned to the calibrators or control justification system Medical Devices Essential Principles Checklist ANARME, IP Page 46 of 47

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material must be assured through a quality management system. Applicable Not applicable Medical Devices / IVD Evidence of compliance Part 2. PRINCIPLES ABOUT DESIGN AND Justification must be standard or other Include direct reference to CONSTRUCTION provided below procedure applied documents within the manufacturer’s quality system 15 Principles applying to IVD medical devices only 15 (4) An IVD medical device must, to the extent reasonably ☐ ☐ List here the standards / Include direct reference to documents (cont.) practicable, include provision for the user to verify, at the time Provide Justification procedures applied with within the manufacturer’s quality of use, that the device will perform as intended by the justification system manufacturer. 15 (5) An IVD medical device for self-testing must be designed and ☐ ☐ List here the standards / Include direct reference to documents (cont.) manufactured so that it performs appropriately for its intended Provide Justification procedures applied with within the manufacturer’s quality purpose, taking into account the skills and the means available justification system to users and the influence resulting from variation that can reasonably be anticipated in the user’s technique and environment. 15 (6) The information and instructions provided by the ☐ ☐ List here the standards / Include direct reference to documents (cont.) manufacturer of an IVD medical device for self-testing must Provide Justification procedures applied with within the manufacturer’s quality be easy for the user to understand and apply. justification system 15 (7) An IVD medical device for self-testing must be designed and ☐ ☐ List here the standards / Include direct reference to documents (cont.) manufactured in a way that reduces, to the extent practicable, the Provide Justification procedures applied with within the manufacturer’s quality risk of error in the use of the device, the handling of the justification system sample and the interpretation of results. Medical Devices Essential Principles Checklist ANARME, IP Page 47 of 47

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