CECP, consultation according to Art 54 MDR

Raisin picker

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#1
Dear all,

Directive (EU) 2017/745 Article 54 requires a consultation procedure (Clinical Evaluation Consultation Procedure, CECP) for certain devices. More details are provided in Annex IX, 5.1.

I now have a device that qualifies for that procedure (no doubt here). The NB claims not to be able to provide the required documents to the expert panel, since the procedures on EU side are not yet established*. Since the CECP is required, the conformity assessment cannot be finalized. Has someone any experience with that procedure and can confirm or contradict that?

*since EUDAMED is not functional yet, a provisional arrangement (CircaBC) is going to be provided, but this is also not available at the moment. This is mentioned in MDCG 2021-1.
 
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Elsmar Forum Sponsor

Raisin picker

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#2
Dear all,

since noone wants to answer my question, I start talking to myself. It seems that the process to provide documents to the expert panel was just established a few days ago, basically directly after I asked here. So now it's just waiting for the answer of the panel, which should come in three weeks, or, if an expert opinion is provided, in 12 weeks (+ the time it takes the NB to adapt the CEAR to the opinion). Maybe just before my summer holiday in August.
 
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