Gap Analysis MDR req/MEDDEV 2.7.1 rev 4

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FoGia

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#2
Welcome to the Cove!


What do you mean exactly? The MDR doesn't cover the same material as the MEDDEV.
No update of the current MEDDEV 2.7/1 is expected, the MDR will likely issue the same guidance but under the MDR banner, the content will remain the same.
 

TheMightyWife

Involved In Discussions
#3
Hi all. please I'm looking for a completed gap analysis between the MDR vs the current MEDDEV 2.7.1. Thanks in advance.
You can find latest MEDDEV and MDCG documents on Europa website (I can't post links, I'm not 'advanced enough' on this forum :D).
MEDDEV apply to directives, MDCG to regulations (as far as I'm aware).
Clinical Evaluation documents are not updated as yet.
All guidance really is in MDR, Article 61 and Part A of Annex XIV

Hope it helps.
 

Marcelo

Inactive Registered Visitor
#4
MEDDEV apply to directives, MDCG to regulations (as far as I'm aware).
In fact, MEDDEVs will need to be revised to apply to the regulations to. MDCG documents are more related to the structural part of the regulations (the same as NBOG documents).

please I'm looking for a completed gap analysis between the MDR vs the current MEDDEV 2.7.1.
I've never seen "complete" gap analysis done in one document, but I've did it in practice to change documents of my clients. It's not that much additional requirements, so in principle it's fairly easy to do it in your own.
 
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