EU MDR: The European Union Medical Device Regulation of 2017
Regulation (EU) 2017/745
Key points addressed in the new EU MDR regulations
The new revisions to the Regulations present very important refinements that modernise the current system. Below are some of the key points presented in the new EU MDR.
- Stricter ex-ante control for high-risk devices
- Reinforcement of the criteria for designation and processes for oversight of Notified Bodies
- Inclusion of certain aesthetic devices
- New risk classification system for in vitro diagnostic medical devices
- Improved transparency
- Introduction of an “implant card”
- Reinforcement of the rules on clinical evidence
- Strengthening of post-market surveillance
- Improved coordination mechanisms
What's new in the new EU MDR?
The new EU Medical Device Regulation (EU MDR) is not radically different from the current Medical Device Directive (MDD). Those who want to continue supplying medical devices beyond 2020, will need to comply with the new EU MDR. Very little of the new EU MDR requirements are completely new. Much of the changes to the regulations are simply brining the old up to date.
- Post Market Surveillance (PMS); Notified Bodies will play a bigger role in supervising the manufacturer’s PMS system. Additionally, the new EU MDR introduces a new requirement to produce a PMS Report or, depending on the device class, a Periodic Safety Update Report (PSUR). Although this is already established practice under EN ISO 14971.
- Unique Device Identification (UDI) – while UDI will be new for Europe, UDI has been an established requirement in the United States for some time already.
- Economic operators; it was clearly an omission that the MDD didn’t include requirements for importers and distributors. The new EU MDR corrects this omission but really only brings European importers and distributors into line with already established practices for importers and distributors of medical devices in other geographies.
- The requirement that at least one person in the organization be formally assigned responsibility for ensuring the regulatory compliance of the enterprise (again not really new for those organizations which already have a Quality or Regulatory Compliance or Safety Manager).
- The extension of the scope of the medical device regulations to products without an intended medical purpose but which are analogous to devices with a medical purpose. This is aimed at medical device like products typically intended for cosmetic purposes. Colored non-corrective contact lenses being the most frequently quoted example.