Guidance for Application Form for Notification of Medical Devices Made Available on the Local Market February 2026 Medical Devices, Pharmaceutical Collaboration & Entrepreneurship Directorate
1. Introduction
The application form for medical device notification is being presented by the Malta Medicines Authority (MMA) to increase transparency and traceability of medical devices being made available on the local market. This will allow the National Competent Authority to identify and track medical devices across the Maltese islands if the need arises. Any further clarification on this guidance document may be obtained from MMA, by sending an email to mdforms.medicinesauthority@gov.mt.
2. Scope
The purpose of this guidance document is to provide comprehensive instructions to the applicant on how to notify the making available of a medical device on the local market with the National Competent Authority. This guidance is intended to offer a robust approach towards the proficiency and control of how the applicant must accurately complete and submit the application form.
3. Terms, Definitions and Abbreviations
Authorised Representative Any natural or legal person established within the Union who has received and accepted a written mandate from a manufacturer, located outside the Union, to act on the manufacturer's behalf in relation to specified tasks with regard to the latter's obligations under the Regulations. [Regulation (EU) 2017/745 & (EU) 2017/746] Basic UDI-DI The primary identifier of a device model. It is the DI assigned at the level of the device unit of use. It is the main key for records in the UDI database and is referenced in relevant certificates and EU declarations of conformity. [Regulation (EU) 2017/745 & (EU) 2017/746] Distributor Any natural or legal person in the supply chain, other than the manufacturer or the importer, that makes a device available on the market, up until the point of putting into service. [Regulation (EU) 2017/745 & (EU) 2017/746] European Database on Medical Devices (EUDAMED) EUDAMED is the European databank for medical devices. It is a secure, web-based portal which enables the exchange of information between National Competent Authorities and the European Commission. Security Marking: Public Importer Any natural or legal person established within the Union that places a device from a third country on the Union market. The importer shall place on the Union market only devices that are in conformity with Article 13 of the Regulations (EU) 2017/745 & (EU) 2017/746. [Regulation (EU) 2017/745 & (EU) 2017/746] In vitro diagnostic medical device (IVD) Any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, piece of equipment, software or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information on one or more of the following: a) concerning a physiological or pathological process or state; b) concerning congenital physical or mental impairments; c) concerning the predisposition to a medical condition or a disease; d) to determine the safety and compatibility with potential recipients; e) to predict treatment response or reactions; f) to define or monitoring therapeutic measures. Specimen receptacles shall also be deemed to be in vitro diagnostic medical devices. [Regulation (EU) 2017/746] Manufacturer A natural or legal person who manufactures or fully refurbishes a device or has a device designed, manufactured or fully refurbished, and markets that device under its name or trademark. [Regulation (EU) 2017/745 & (EU) 2017/746] Medical Device Any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes: • diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease, • diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability, • investigation, replacement or modification of the anatomy or of a physiological or pathological process or state, • providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations, and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means. Security Marking: Public The following products shall also be deemed to be medical devices: • devices for the control or support of conception; • products specifically intended for the cleaning, disinfection or sterilisation of devices as referred to in Article 1(4) and of those referred to in the first paragraph of this point. [Regulation (EU) 2017/745] Medical Device Registered Person (MDRP) A person appointed by an economic operator, with a place of business in Malta, who is responsible for ensuring regulatory compliance of medical devices placed on the Maltese market. This person must be registered with the Malta Medicines Authority. [S.L. 458.59] Person Responsible for Regulatory Compliance A person with regulatory expertise who is appointed by a manufacturer or authorised representative to ensure regulatory compliance of medical devices with EU Regulations, at least ensuring that: (a) the conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released; (b) the technical documentation and the EU declaration of conformity are drawn up and kept up to date; (c) the post-market surveillance obligations; (d) the reporting obligations; (e) in the case of investigational devices, as per Regulations. [Regulation (EU) 2017/745 Article 15 & Regulation (EU) 2017/746 Article 15] Single Registration Number (SRN) Generated by EUDAMED and issued by the Competent Authority after validating the registrations request. [Regulation (EU) 2017/745 Article 31(2) & Regulation (EU) 2017/746 Article 28(2)] Source Country Supplier The supplier’s name and address from where the applicant (Economic Operator) acquired the devices Unique Device Identification (UDI) A series of numeric or alphanumeric characters that is created through internationally accepted device identification and coding standards and that allows unambiguous identification of specific devices on the market. [Regulation (EU) 2017/745 & (EU) 2017/746] Security Marking: Public UDI-DI A unique numeric or alphanumeric code specific to a model of device and that is also used as the ‘access key’ to information stored in a UDI database. [Regulation (EU) 2017/745 & (EU) 2017/746] Variant Devices bearing the same Basic UDI-DI will be considered as variants. In cases where the Basic UDI-DI is not available, variants refer to groups of devices with the same intended purpose and the same manufacturing process but may vary in their characteristics. Such characteristics include, but are not limited to, size, colour and version. Example 1: Wrist support with splint, wrist support without splint, hand and wrist support without splint of the same brand are not considered variants, but separate devices and therefore requiring individual fee. Example 2: Syringes of same brand, different volume (mL) sizes, require one notification fee. Example 3: Catheters of same brand, different gauges, require one notification fee. Abbreviations: DoC: Declaration of Conformity EUDAMED: European Database on Medical Devices GDPR: General Data Protection Regulation IVD: In vitro diagnostic medical device MDRP: Medical Device Registered Person MMA: Malta Medicines Authority PRRC: Person Responsible for Regulatory Compliance UDI: Unique Device Identification UDI-DI: Unique Device Identification - Device Identifier SRN: Single Registration Number Security Marking: Public
4. Specific Guidance
4. Specific Guidance
4.1. Applicants applying through the Medical Device Notification Form
The application form for notification of medical devices made available on the local market, may be submitted by economic operators with a registered place of business in Malta and economic operators with a registered place of business out of Malta but with no local supplier in Malta. Economic operators with a registered place of business in Malta submitting the application must be registered with the Malta Medicines Authority. The applicant may create a new notification or make amendments in details of a previously notified medical device.
4.2. General Details related to Applying
Application Form Title The application form related to this guidance document is MT-MDF05 - Application Form for Notification of Medical Devices Made Available on the Local Market, which may be accessed from the MMA website https://medicinesauthority.gov.mt/medicaldevices. Application Format The application is in a fillable word format which must be filled in electronically using the grey-shaded areas. Handwritten application forms will not be accepted. The completed application and supporting documentation must be submitted to the Authority via email to mdforms.medicinesauthority@gov.mt. Acknowledgement Once the application form has been successfully received and reviewed, an acknowledgment will be sent to the applicant’s electronic address. Official Languages The official languages in Malta are Maltese and English. The application form and all supporting documentation must be completed in either Maltese or English.
4.3. Filling in the Application Form
All sections must be completed. The Registration Form is divided as follows: • Section A: Application Introduction • Section B: Manufacturer Contact Details • Section C: Authorised Representative Contact Details • Section D: Device Notification Sheet • Section E: Details of Payment • Data Protection Consent Statement • Additional Documentation • Self-Declaration for Medical Device Notification/s • Malta Medicines Authority Declaration for Form Submission Security Marking: Public Section A: Application Introduction This section is divided into four parts: Date of Application and applicant details The individual completing the application shall provide the following information: Date of the application, applicant’s name, surname, email address and contact number. Notification Type The applicant shall tick whether this is a first-time notification of a medical device or a previously notified device requiring an amendment. If the application aims to amend a previously notified medical device, the applicant must tick, as appropriate, either amendment or revocation of the current details. Applicant Type The applicant shall tick whether the economic operator is with a registered Place of Business in Malta or the economic operator is with a registered Place of Business out of Malta but with no local supplier in Malta. Applicant Organisation Details The applicant organisation type, organisation name, organisation address, the organisation registration number and Single Registration Number (SRN) must be inputted in the fields provided. The organisation registration number is given to organisations that have already registered with the MMA. For further information on organisation registration kindly refer to guidance document GL-MDF02 ‘Guidance for Application for Organisation Registration in relation to Medical Devices’ and application MT-MDF02 ‘Application Form for Organisation Registration in relation to Medical Devices’ which may be accessed from the MMA website https://medicinesauthority.gov.mt/medicaldevices. Section B: Manufacturer Contact Details The manufacturer contact details shall correspond with the details on the Declaration of Conformity (DoC) of the medical device being notified. It is the responsibility of the applicant to update the MMA of any changes in these contact details. SRN refers to, if applicable, the Single Registration Number generated by EUDAMED. Section C: Authorised Representative Contact Details This section must be completed if the manufacturer is not located in an EU Member State. In such a case, both contact details of the authorised representative, and the manufacturer they represent need to be filled in. It is the responsibility of the applicant to update the MMA of any changes in these contact details. SRN refers to, if applicable, the Single Registration Number generated by EUDAMED. Security Marking: Public Section D: Device Notification Sheet The applicant must list all devices being made available on the local market, including variants. Refer to definition of variant in this Guidance. The device notification sheet has the following headings: Source Country Supplier: The supplier’s name and address from where the applicant (Economic Operator) acquired the devices must be completed. It is the responsibility of the applicant to update the MMA of any changes in these details. MMA Reference Number, Product Brand Name, Generic Name, Catalogue Number, Device Type, Class and, where applicable, Basic UDI-DI and UDI-DI. MMA Reference Number: The unique number given by the MMA per medical device upon initial registration. This number must be quoted for revision and revocation applications only. Product Brand Name: Mandatory, the product brand name of the medical device as written on the DoC. Generic Name: Mandatory, the generic name of the medical device as written on the DoC. Catalogue Number: Mandatory, the catalogue number of the medical device as written on the DoC. Device Type: Mandatory, the type of the medical device as written on the DoC. Class: Mandatory, the Class of the medical device as written on the DoC. Basic UDI-DI: Where applicable, the Basic UDI-DI of the medical device as written on the DoC. UDI-DI: Where applicable, the UDI-DI of the medical device as written on the DoC. Section E: Details of Payment Reference should be made to the GL-MDF07 Guidance on fees in relation to Medical Devices available on the MMA website https://medicinesauthority.gov.mt/medicaldevices. The fee quoted is per Basic UDI-DI device. The relevant proof of payment document must be attached. Security Marking: Public Timeframe Upon submission of all the relevant documentation and proof of payment: • Standard Service: Processing of up to 30 working days from receipt of the application form at Malta Medicines Authority. • Fast Track Service: Processing of up to 10 working days from receipt of the application form at Malta Medicines Authority. Should the MMA require any further information or clarification, this will be communicated to the applicant. A stop-clock will be initiated, and the clock will be restarted upon receipt of responses. If further queries arise or responses are not satisfactory, the applicant is informed, and clock stops/starts accordingly with the cycle repeating itself. The applicant may withdraw the application at any stage of its processing, by sending an email to mdforms.medicinesauthority@gov.mt. It should be noted that in such cases, payments will not be reimbursed or credited. Device notification is renewable on an annual basis. The procedure for annual fees relevant to product notification (MT-MDF05) is described in GL-MDF07 Guidance on Fees in relation to Medical Devices. Proof of Payment This document will be verified by the Finance & Corporate Services Unit at the MMA, confirming receipt of funds. Data Protection Consent Statement Applicant shall confirm consent, by ticking the box in this section, to the processing of personal data by the MMA and understands that this data shall be processed in accordance with the General Data Protection Regulation (GDPR). Self-Declaration for Medical Device Notification/s The regulatory affairs person of the economic operator shall complete and sign the self- declaration that the medical devices being notified are in compliance with the applicable EU and national legislations. The regulatory affairs person refers to the MDRP or PRRC, as applicable, while in case the economic operator has a registered Place of Business in Malta while for economic operators with a registered Place of Business out of Malta but with no local supplier in Malta, the regulatory affairs person refers to the PRRC or a person responsible for regulatory affairs for other economic operator types, as applicable. Malta Medicines Authority Declaration for Form Submission Applicant shall sign the MMA declaration that all the information submitted within this request form is correct and complete.
4.4. Documents Required
The documents to be submitted with this application form are: • Device notification sheet • Declaration of Conformity (DoC) • Proof of payment (softcopy) Security Marking: Public Any additional documents relevant to the function of the organisation/medical device must be made available to the MMA, upon request. For an application to be considered, all sections must be filled in completely and accurately as per this guidance document. Sections not applicable to your organisation must be filled in with N/A. If, during application review, the Authority does not receive feedback from the applicant within 90 working days from the last communication from the Authority, the application will be automatically refused. It is the applicant's responsibility to ensure that all required feedback and documentation are provided within the specified timeframes.
5. References
Cap 458 Act no VII of 2020, An Act to amend the Medicines Act https://legislation.mt/eli/act/2020/7/eng S.L. 458.59 Medical Devices and In-Vitro Diagnostic Medical Devices Provision On The Maltese Market Regulations https://legislation.mt/eli/sl/458.59/eng EU legislations: https://health.ec.europa.eu/medical-devices-sector/new-regulations_en Signatures on file List of Appendices N/A Security Marking: Public