What is EU MDR?
No "Grandfathering" provisions: All currently approved products must be re-certified starting MAY 2020
Multiple changes but
re-registration may be most significant
EU MDR was in force 25 MAY 2017 and replaces the EU Medical device Directives (93/42/EEC and 90/385/EEC). Changes include:
- Changes in the scope of products covered
- More rigorous clinical evaluation
- Mandatory Unique Device Identification (UDI)
- No “grandfathering” provisions. All currently approved devices must be recertified
- Risk classified devices have changed
Could you submit your legacy product documentation today for a new 510(k)?
Let us work with your notified body to perform a gap assessment of your documentation. TUV recommends partnering with notified body early as the backlog of re-registrations will be significant
Test drive us. Hire us to perform a gap analysis on your legacy medical device. Does your documentation conform to your current requirements for new products? Is your document up to date with required standards including biocompatibility, IEC 60601 electrical testing, and ISO 14971 Risk Management?