Hello Anon,
Ahh the joys of the united Union of European countries. It would be really fantastic the national Competent Authorities spend their energy supporting and working on EUDAMED rather than creating additional barriers for the "single" market. There are indeed additional registration requirements many countries have depending on type of device, though generally relegated to Class I. For Greece, you might check here https://www.eof.gr/web/guest/proceduremedical for some forms and evidence used for registration requirements provided to EOO (NOM). There also might be a fee, so check that as well. In my experience, typically you can provide the Declaration of Conformity (DoC) which many accept and some national authorities require certain information there as well, so double-check. I will have a party when EUDAMED is fully functional and being used as it should :).
Note: There are a couple resources out there which provide some information on which countries need additional registration above and beyond only having a CE Mark.
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Richard Vincins ASQ-CQA, MTOPRA, RAC
Principal Strategy Consultant
NAMSA
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Original Message:
Sent: 08-May-2024 13:38
From: Anonymous Member
Subject: Certificate of registration for Class I devices under EU MDR
This message was posted by a user wishing to remain anonymous
Hi there, I'm wondering if anyone knows what's meant by a 'Certificate of Registration' for Class I devices under EU MDR? I have a Class I device registered with the Swedish CA and am aiming to register with the few individual member states who require additional registration. The Greek CA have requested a Certificate of Registration however I'm not sure what's meant by this as there was no certificate issued by the CA. Our EAR has offered to provide a custom-made EAR Certificate of Registration for an additional cost but the way I understand it is that this isn't a requirement to place the device on the market. The Greek CA have indicated that the Certificate of Registration is something that we (or our EAR) should have provided to the Swedish CA. Any ideas? Thank you in advance.