Can we still use MEDDEV 2.4/1 rev. 9 when classifying a medical device product under MDR?

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twanmul

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#2
You're not able to for a few reasons, the first being that the MEDDEV are "GUIDELINES RELATING TO THE APPLICATION OF THE COUNCIL DIRECTIVE 93/42/EEC ON MEDICAL DEVICES." The second being that Article 122 of the MDR outlines the repealing of the applicable council directives.
The MDR and any associated guidelines should be used for classification under the MDR.
 

Watchcat

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#4
Well, that's what's in writing.

Practically speaking, there are not many guidelines associated with the MDR yet, so my expectation is that the NBs will continue to accept conformance (or something like it) to the MEDDEVs for awhile, as long as the information in the MEDDEV doesn't conflict with that in the MDR, and no MDR-specific guidance is available.

I know at least one of the MDR-designated NBs has advised clients to stick with MEDDEV 2.7.1 Rev 4 (CERs) for the time being. There is eventually going to be a Rev 5, but with all the additional emphasis on clinical data in the MDR, it's going to be a long time coming, I think. There is of course information in the MDR itself about CERs, but not enough to really guide the writing of one, I don't think.

But I would definitely not ignore the MDR and just follow a MEDDEV. I think that would be a big mistake.
 
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