European Commission complains to US FDA over criticism of EU system
This article was originally published in SRA
The European Commission has written to the US Food and Drug Administration objecting to the apparent suggestion by the agency’s devices centre head that the EU treats its patients as rodents in medical device experiments.
You may also be interested in...
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?
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.
Do you know how to avoid the pitfalls when it comes to clinical evidence under the MDR? Or whether evidence gathered outside the US counts? Amie Smirthwaite of Maetrics answers these and other pivotal questions in this third and final part of an interview series with Medtech Insight.