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?
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How TÜV SÜD Issues First Certificate Under EU’s IVD Regulation And Says Technical Documentation Is Key
Notified body TÜV SÜD has issued the first certificate under the EU’s IVD Regulation. The notified body has fundamental advice for manufacturers wanting to ensure their IVDs are compliant in time.
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.