An overview of the new European Regulation on medical devices (MDR).
After years of negotiations in the European Parliament, the European Union issued on May 25, 2017:
- Regulation (EU) 2017/745 on medical devices (MDR) with full application in May 2020 and
- Regulation (EU) 2017/746 on in-vitro diagnostic medical devices.
The main news of MDR in comparison with the previous Medical Device Directive (MDD)
The following table summarizes the main differences between MDR and the previous MDD; the first one is the new rules have the legal form of “regulation” and in contrast to “directive”, it enters directly into force in the EU Member States and does not have to be transferred into national law.
The following list summarizes the main differences between MDR and the previous MDD; the first one is the new rules have the legal form of “regulation” and in contrast to “directive”, it enters directly into force in the EU Member States and does not have to be transferred into national law.
- Definition of medical device: In MDR it has been broadened to include non-medical and cosmetic devices that were not regulated under MDD e.g. liposuction equipment
- Reclassification of devices: In MDR there is a tighter link of the classification of the device to the involved risk; many products including many apps were moved up to Class IIa, and some AI-based software to Class IIb
- Surveillance by Notified Bodies: MDR foresees greater scrutiny of Notified Bodies and more rigorous surveillance i.e. a stronger emphasis on vigilance reporting, Post Market Clinical Follow-up (PMCF) and Post Market Surveillance (PMS) collection data. Manufacturers have to involve notified bodies in the certification process with the only exception of class I medical devices and nonsterile class A in-vitro diagnostic medical devices, for which the manufacturer’s self-declaration is sufficient.
- Safety: MDR gives stronger emphasis on safety; as an example the Annex I - “General Safety and Performance Requirements” (GSPR) identifies new conditions that must be addressed.
- Clinical evidence: More rigorous clinical evidence is required for implantable devices and class III devices
- Unique Device Identification (UDI): MDR implements UDI and it will make easier to track versions of devices
- European database on medical devices (EUDAMED): The database foreseen by MDR will make stronger the market surveillance and easier the traceability; as well it will ensure that the public is adequately informed about new devices placed on the market
- Clear identification of responsibility: MDR asks for the identification of the “person responsible” for regulatory compliance within the company.