Is the new EU medical device legislation worth the wait?
Understanding the new legislation
Divergence in the interpretation and application of EU rules, advances in technology and a need to respond to incidents such as the PIP breast implant scandal, has prompted the European Commission to introduce new rules for the regulation of medical devices. Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in-vitro diagnostics (IVDR), introduced on 26 May 2017, supersede three earlier Medical Device Directives (MDD) dating back to the 1990s. MDR will be fully applicable from 26 May 2020 while IVDR will be fully applicable from 26 May 2022.
The new Regulations require:
- Re-certification of existing products and compliance with the General Safety and Performance Requirements;
- Updates to technical documentation, clinical data and labelling;
- Implementation of Unique Device Identification (UDI) to track devices;
- Classification of IVDs, which now require notified body review.
There is a staggered transitional period with some aspects, such as the notified body requirements, already legally binding since 26 November 2017 while others are not fully applicable until 2022.
Like the new EU Clinical Trials legislation, MDR and IVDR take the form of Regulations which means they are directly applicable and do not need to be transposed into national law. This should minimise differences of interpretation and improve consistency in the medical device industry across the EU.