Definition of a Medical Device in Europe
The definition of Medical Device (MD) is given in the European Regulation (EU) 2017/745 (MDR : Medical Devices Regulation) which defines the regulatory framework to ensure the safety and performance of products and a favorable benefit/risk ratio.
This article makes the point on which devices are covered by the regulation and which are not.
Definition of Medical Device in regulation (EU) 2017/745
The definition is given in Article 2 of the Regulation (EU) 2017/745 :
A Medical Device is 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.
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 medical devices.
Notions of “prediction and prognosis of a disease”
These terms are not defined in the regulations, let’s look at the CNRTL:
Prediction: The observation of a set of data that allows to envision a future situation and to take action to address it in a practical way.
Prognosis: A conjectural judgment of what should happen.
An addition tailored for increasingly intelligent software, which, like IBM’s Watson, tends to offer Artificial Intelligence in support of healthcare professionals.
Medical device accessories are also subject to MDR
The situation of accessories is clarified in Chapter I, Article 1:
This Regulation lays down rules concerning the placing on the market, making available on the market or putting into service of medical devices for human use and accessories for such devices in the Union.
Thus, a medical device accessory is subject to the Medical Devices Regulation, the manufacturer will have to follow the CE marking process defined for Medical Devices.
Note the definition of accessory :
An accessory for a medical device is any article which, whilst not being itself a medical device, is intended by its manufacturer to be used together with one or several particular medical device(s) to specifically enable the medical device(s) to be used in accordance with its/their intended purpose(s) or to specifically and directly assist the medical functionality of the medical device(s) in terms of its/their intended purpose(s).
Annex XVI: nonmedical products
This is a special case: the Annex XVI provides a list of product groups that have nonmedical purpose, but are nevertheless covered by the Regulation.
These are essentially aesthetic devices whose technologies and uses are close to Medical Devices.
The list of groups, examples of classification and an analysis of the requirements applicable to these products are offered in the article on the impact of Annex XVI for nonmedical devices.
Case of devices with a dual attribute
Medical Device incorporating a medicinal product
- If the action of the medicinal product is ancillary to that of the device: the device is subject to the Medical Devices Regulation.
- If the action of the medicinal product is principal and not ancillary to that of the device: the device is subject to the Medicinal Product Regulation, but the safety and performance requirements of the Medical Devices Regulation (Annex I) are applicable to the medical device part.
Medical Device incorporating a substance of human origin
Two cases defined for Medical Devices incorporating tissues or cells of human origin or their derivatives, depending on the action of its substances:
- The action is ancillary to that of the device: the Medical Devices regulation applies + human tissue and cell directive.
- The action is principal: Annex I of the Medical Devices Regulation + Advanced Therapy Medicinal Products Regulation or Human Tissues and Cells Directive.
Medical Device intended for the administration of a medicinal product
- The Medical Device does not incorporate the medicinal product: device governed by the Medical Devices regulation.
- Medical Device and medicinal product are integrated into the same product: Medicinal Products Regulation + annex I of the Medical Devices regulation.
Devices with medical & nonmedical purposes
These devices are logically concerned by the Medical Devices regulation and by the other applicable regulations:
Devices with both a medical and a non-medical intended purpose should fulfil both the requirements applicable to devices with, and to devices without, an intended medical purpose.
Medical Device incorporating an IVD (In Vitro Diagnostic device)
No suspense, the IVD part of the device is subject to the MD-IVD regulation :
Any device which, when placed on the market or put into service, incorporates as an integral part an in vitro diagnostic medical device as defined in point 2 of Article 2 of Regulation (EU) 2017/746, shall be governed by this Regulation. The requirements of Regulation (EU) 2017/746 shall apply to the in vitro diagnostic medical device part of the device.
Medical Devices that are also machines
The machines are covered by the Directive 2006/42/EC concerning (to put it simply) devices incorporating an energy source and moving parts.
Where there is a particular hazard the Annex I of the Machinery Directive (the essential health and safety requirements relating to design and construction) must be complied with in addition to the requirements of the regulation. They are considered more suitable for making the product safe to use.
Devices outside the scope of the European regulation for medical devices
These products are subject to other regulations, but at least part of the Regulation (Annex I) may be applicable.
A list of products not covered by the Regulation is given in I.1.2 and in II.4 :
- Medicinal products,
- Medical Devices manufactured and used exclusively in healthcare facilities, the device must not be manufactured on an industrial scale, there must be no equivalent MD already on the market,
- Human blood, blood products, plasma, blood cells, organs, tissues, … of human origin
- Organs, tissues, cells, … of animal origin,
- Products that contain or consist of viable biological materials or organisms,
- Cosmetics products,
- Food products.