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.
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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