Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 onin vitro diagnostic medical devices
This new legislation will apply after a transitional period: new rules about medical devices will apply on 26 May 2020 and the ones regarding in vitro medical devices on the spring of the year 2022.
CE marking of medical devices
The CE mark of medical devices is a logo that is placed on medical devices to show it is conform wth the requirements of Regulation (EU) 2017/745and with the other harmonisation standards of the EU concerning CE marking.
CE marking means that the product can freely be marketed in EEA (the EU 28 member states plus Iceland, Norway and Liechtenstein).
CE marked medical devices are subject to inspection by the competent authorities of the relevant member state.
Medical Devices legislation
Contact lens: class IIa medical devices
Stent : class III medical device
Scanner: class IIb medical device
Breast implants: class III medical devices
What is a medical device?
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 devices as referred to in Article 1(4) of Regulation (EU) 2017/745and of those referred to in the first paragraph.
Medical devices classification scheme in EU
Medical devices are assigned to one of four classes based on the the risk associated with the use of the device:
classe I - Low risk. Examples : compresses, wheelchairs, reusable scalpels;
classe III - High risk. Examples : breasts implant, active coronary stent, hip prosthesis.
European Union legislation on Medical Devices
EU Medical devices (MDD) and active implantable medical devices (AIMDs) legislation follows the "New approach" principle. The new approach is part of the dispositions put in place by the European Union Council to harmonise the legislation of member states and facilitate the functionning of the internal market. This approach has been completed by a more global approach which established the conformance evaluation procedures to which the "New Approach" directives must refer to.
Medical devices are currently regulated by the following 3 directives:
Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices (AIMDD)
Council Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 onin vitro diagnostic medical devices (IVDMD)
New Medical Devices European Regulations
The new rules on medical devices and in-vitro diagnostic medical devices will apply from May 2020 for medical devices and 2022 for in vitro medical devices. The new Regulations will Improve quality, safety and reliability of medical devices as well as market surveillance and traceability and provide more transparency for producers, manufacturers, importers and consumers.
Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices (Medical Device Regulation, MDR)
Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices (In vitro Medical Device Regulation, IVDR).
Key aspects of the new Medical devices regulation (MDR) and of the in-vitro diagnostic medical device regulation (IVDR)
A broader definition of medical device extending it to products without an intended medical purpose (listed en annexe XVI). Probiotics are excluded.
The reinforcement of the requirements to become a notified body and processes for oversight of notified bodies by authorities. The establishment of "super" notified bodies which will be responsible for high-risk implantable devices. Notified bodies are designated at EU level. National authorities monitor the performance of notified bodies based in their territory.
A sector regulation at European level is established with national authorities working closely together in a coordination group and in conjunction with the European Commission.
The reinforcement of the rules on clinical studies of medical devices and its assessment.
New obligations for economic operators (companies must retain at least one responsible person for regulatory compliance; establishment of caution obligations for importers and distributors).
Enhanced vigilance and market surveillance with the establishment of a centralized European database for the storage of information on medical devices, including technical data, clinical trial results and adverse event reports (EUDAMED) and the obligation to manufacturers, under the control of a notified body, to prepare Periodic Safety Update Reports (PSUR).
Improved transparency (including the publication of clinical trial data and safety summaries) and traceability (new device traceability system based on Unique Device Identifier (UDI)).
Some practices such the manufacture of medical devices by healthcare institutions and the reprocessing of single-use devices are subject to a stricter and more harmonized regime.
High-risk devices are going to be subject to stricter pre-market control.
Implementation of an "implant card" containing information about implanted medical devices for a patient.
Introduction of a new risk classification system for in vitro diagnostic medical devices (four different classes, from class A (low risk) to class D (high risk)).