2.38. Medical device means
2.38 Medical device means (a) any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings, for one or more 6 / 15 GN-00:2026-1(E) of the specific medical purpose(s) of : 2.38.1 diagnosis, prevention, monitoring, treatment or alleviation of disease; or 2.38.2 diagnosis, monitoring, treatment, alleviation of or compensation for an injury; or 2.38.3 investigation, replacement, modification, or support of the anatomy or of a physiological process; or 2.38.4 supporting or sustaining life; or 2.38.5 control of conception; or 2.38.6 disinfection of medical devices; or 2.38.7 providing information by means of in vitro examination of specimens derived from the human body; and does not achieve its primary intended action by pharmacological, immunological, or metabolic means, in or on the human body, but which may be assisted in its intended function by such means; or (b) any items listed in Appendix 1. 2.39 According to the characteristics and nature, medical device can be classified into at least the following different types: 2.39.1 Active device intended for diagnosis means an active medical device, whether used alone or in combination with other medical devices, to supply information for detecting, diagnosing, monitoring or to support in treating physiological conditions, states of health, illnesses or congenital deformities. 2.39.2 Active implantable medical device means any active medical device, together with any accessories for its proper functioning, which is intended to be totally or partially introduced, surgically or medically, into the human body or by medical intervention into a natural orifice, and which is intended to remain after the procedure. 2.39.3 Active medical device means a device whose operation depends on a source of electrical energy or any source of power other than that directly generated by the human body or gravity and which acts by converting this energy. Medical devices intended to transmit energy, substances or other elements between an active medical device and the patient, without any significant change, is not considered to be active medical devices. 7 / 15 GN-00:2026-1(E) 2.39.4 Active therapeutic device means an active medical device, whether used alone or in combination with other medical devices, to support, modify, replace or restore biological functions or structures with a view to treatment or alleviation of an illness, injury or handicap. 2.39.5 Implantable medical device means any device, including those that are partially or wholly absorbed which is intended- (i) to be totally introduced into the human body; or (ii) to replace an epithelial surface or the surface of the eye, by surgical intervention which is intended to remain in place after the procedure. Any device intended to be partially introduced into the human body through surgical intervention and intended to remain in place after the procedure for at least 30 days is also considered an implantable device. 2.39.6 Invasive device means a device, which, in whole or in part, penetrates inside the body, either through a body orifice or through the surface of the body. 2.39.7 Surgically invasive device means an invasive device which penetrates inside the body through the surface of the body, with the aid or in the context of a surgical operation. 2.40 Near patient (testing) means testing performed outside a laboratory environment by a healthcare professional not necessarily a laboratory professional, generally near to, or at the side of, the patient. 2.41 Patient-matched medical device see Personalised medical device. 2.42 Performance evaluation means review of the performance of a medical device based upon data already available, scientific literature and, where appropriate, laboratory, animal or clinical investigations. 2.43 Personalised medical device means a generic term to describe any of the types of medical devices that are intended for a particular individual, which could be either a custom-made, patient-matched, or adaptable medical device. 2.43.1 Custom-made medical device means a medical device that meets the following requirements: 8 / 15 GN-00:2026-1(E) (a) It is intended for the sole use of a particular individual (which could be a patient or healthcare professional); (b) It is specifically manufactured in accordance with a written request of a healthcare professional, which gives, under their responsibility, specific design characteristics; even though the design may be developed in consultation with a manufacturer; (c) It is intended to address the specific anatomo-physiological features or pathological condition of the individual for whom it is intended; and (d) It is typically intended for a case where an individual’s specific needs cannot be met, or cannot be met at the appropriate level of performance, or by an alternative device available on the market. 2.43.2 Patient-matched medical device means a medical device that meets the following requirements: (a) It is matched to a patient’s anatomy within a specified design envelope using techniques such as scaling of the device based on anatomic references, or by using the full anatomic features from patient imaging; (b) It is typically produced in a batch through a process that is capable of being validated and reproduced; and (c) It is designed and produced under the responsibility of a manufacturer even though the design may be developed in consultation with healthcare professional.
