EU centralised device committee contender specifies notified body action needed
This article was originally published in RAJ Devices
The Central Management Committee, an organisation made up of competent authority representatives from every EU member state, believes that the European Commission and the member states need more specific and mandatory designation criteria for notified bodies – especially in the fields of competency, qualification and impartiality1.
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.