NEW EUROPEAN REGULATION ON MEDICAL DEVICES
Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
The 5th of April 2017, a new European Regulation 2017/745 on medical devices was adopted by the European Parliament and the Council.
According to the first recital of the European Regulation 2017/745, the main objective is based on the idea that a “fundamental revision of those Directives is needed to establish a robust, transparent, predictable and sustainable regulatory framework for medical devices which ensures a high level of safety and health whilst supporting innovation”.
This Regulation aims in particular at:
- Integrating some products that have an “aesthetic” function and not a medical one (e.g. fancy contact lenses, body implants or UV and infrared device) within the scope of EU Regulation 2017/745 in order to impose stricter controls on the evaluation of conformity due to their similarities with medical provisions and potential risks for patients’ health (Annex XVI – European Regulation 2017/745 – List of groups of products without an intended medical purpose referred to in article 1, paragraph 2).
- Simplifying the procedure of registration of medical devices at a European level for medical devices’ producers or other concerned people (importers, representatives, economic operators…) (CHAPTER III of the European Regulation 2017/745 – Identification and traceability of devices…).
- Putting in place a regular control of the high risks related to some devices with the creation of an independents experts’ panel gathered in the Medical Device Coordination Group (MDCG) – (CHAPTER VIII of the European Regulation 2017/745 – Medical Device Coordination Group).
- Strengthening the European database for medical devices (Eudamed) by expanding the application scope of information available to the general public (the “unique device identifier” (UDI); overviews on the safety and clinical performance; vigilance data including market surveillance; requests for conformity assessment of a device by the notified bodies (CHAPTER III of the European Regulation 2017/745 – … Summary of safety and clinical performance and European database on medical devices).
- Strengthening the cooperation between the Member States’ notified bodies with the entry into force of the MDCG and the control of the notified bodies’ activities and the nomination of an authority in each Member state responsible for the notified bodies (CHAPTER IV of the European Regulation 2017/745 – Notified bodies).
In order to allow the manufacturers and the notified bodies to adapt themselves to these new provisions, a transition period of three years has been planned from May 2017. The new provisions will be applicable from 26 May 2020. The manufacturers, other concerned stakeholders (importers, etc) and the Member States’ competent authorities will have that date to adapt their medical devices (and other products that fall within the scope of the Regulation) in order to conform to the new requirements.