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About SRN request by Notified Bodies

2019-07-10 _ About SRN request by Notified Bodies

Dear Partners,

You may already have been confronted and still might be confronted to a question asked by your Notified Bodies about mentioning SRN (Single Registration Number) on their application forms, could the SRN required be yours - as Manufacturers- , or ours - as your EAR.

It had started with Class 3 devices application forms and since been enlarged to all other products.

But of course, SRN are not available right now, as they will only be obtained from EUDAMED (after NCAs approval to SRN request, furthermore !)

So we are pleased to inform you that it is no longer an issue : it is now admitted that a mere "TBD" (To Be Done) mention will be enough for this requirement - at least as long as EUDAMED hadn’t gone live.

With our best regards,

MME Team

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