Notify Competent authorities per Article 83 point 4 for PMS related CAPAs

We are a manufacturer of Class IIa medical devices, based in The Netherlands. How do we inform CAs for CAPAs issued in the course of the post-market surveillance according to Article 83(4) of MDR? Our NB issued a major nonconformity because of this.

1. MDCG 2021-1 rev.1 does not mention this article either.
2. MDCG 2022-21 says that PSUR can be used for this purpose. And for Class-IIa we do not have to submit our PSUR. It will be kept upon request from CA and NB.
3. Dutch CA does not have any channel to submit PMS-related CAPAs on its website.

It would probably help to post the exact finding from the NB. They should be citing a requirement that you failed to meet.

yodon said:

It would probably help to post the exact finding from the NB. They should be citing a requirement that you failed to meet.

Click to expand...

Here it is :
EN-ISO 13485 clause 7.2.3 and MDR Article 83.4
There was a CAPA we issued. They mentioned the story of CAPA and added this sentence "Competent authorities and Notified Body were not informed on this case."

Ah, ok, thanks. That's making more sense now. Your CAPA arose from some postmarket surveillance activities that indicated the device was in some way deficient / insufficient, right?

Article 86 does say that you are to do a PSUR for Class IIa - and this may fall into the "when necessary" category (so as not to wait for the full 2-yr cycle). Why not go ahead and submit it?