MDR Clinical Evaluation & investigation (SUMMARY of changes)

[mgloria]

Recently I have been reading the new MDR and assisted several webinars. This is my summary of changes. Hope it helps y'all!

I would be grateful for your feedback and also if after reading you can think of:

-any important implications for industry I have not listed
-the answer to any of the 3 questions (at the end, in red)

this would help me a lot too
.

 

[FoGia]

Thanks for the interesting document!

An important one imo overall is the increased visibility to the public of the clinical evaluation and results of clinical investigations through the summary of safety and clinical performance for implantables and cladd III devices(art. 32).

 

[paulag]

Hi mgloria,

As far as I know, a new revision of the clinical evaluation meddev (2.7.1 Rev 5...) is expected for clarification of EU MDR requirements - that might answer your red questions