Deadlines Needed For Urgent EU MDR Vigilance And Postmarket Surveillance Guidance Documents
Executive Summary
Some 46 guidance documents still need to be drafted by the European Commission’s Medical Device Coordination Group before the EU MDR comes into force and time is running out, especially for postmarket responsibilities.
You may also be interested in...
Vigilance And Postmarket Surveillance: Companies Must Avoid Getting Caught Out By May 2021 Deadline
There is no choice: manufacturers must start EU MDR compliance now, however incomplete implementation is. And some MDR clauses apply to all products as of May 2021, regardless of the grace period.
Notified Body Pain Points: The Challenges And Obstacles Industry Needs To Avoid
Where are the biggest challenges for notified bodies and manufacturers now there is some experience with the MDR, and can the sector manage the new regulatory requirements successfully?
Long-Awaited EU IVD Classification Guidance Just Published: Initial Reactions
The European Commission has finally published detailed guidance on the EU IVDR’s classification rules. The IVDR’s completely new classification regime means guidance is urgently needed.
Need a specific report? 1000+ reports available
Buy Reports
Register for our free email digests: