Hello Anon,
Unfortunately the European Commission is breaking their own rules again just like they did with the MEDDEV documents.
MDCG documents are guidance documents but some of them now have requirements in them including 2019-8 and 2021-11. I absolutely love how they write in the regulation 'device model' then in 2019-8 they write 'device type' with a footnote 2. Then in footnote 2 they wrote: 'oops ! we messed up on the nomenclature in the regulation because now that we are implementing things ... this is what it really means !' Bahhh - well enough about that point ...
To address your point, no the MDCG are guidance documents not delegating acts. But just like the MEDDEV guidance, you should read these and apply appropriately. The issue you raised about plates and screws within your own product offerings you need to conduct a risk-based approach to how you handle implant cards. The list in Article 18 subpoint 3 is fairly broad. Obviously this may not be applicable in all cases because some plates and screws are used in systems or more crucial clinical applications. If you decide not to complete an Implant Card for your device, you better have a really good rationale documented in your benefit-risk profile, your technical documentation, and risk management file otherwise you will be challenged by a regulatory authority.
Yes, it is confusing. Good job EU.
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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 21-Jun-2021 13:02
From: Anonymous Member
Subject: Implant Cards: Article 18.3 versus MDCG 2021-11
This message was posted by a user wishing to remain anonymous
Article 18.3 of the EU-MDR exempts "plates" and "screws" from requiring an Implant Card.
MDCG 2021-11 (Guidance on Implant Card – 'Device types', May 2021) includes "Cranio-facial reconstruction Implant" in its non-exhaustive list of implantable medical 'device types'.
There are several types of Cranio-facial reconstruction implants on the market. Plates and screws are types of cranio-facial reconstruction implants.
Therefore, are cranio-facial plates and screws exempt from the Implant Card requirement per Article 18.3? If so, it seems that other types of cranio-facial reconstruction implants not listed in Article 18.3 would require an Implant card.
Or, does MDCG 2021-11 qualify as a delegated act in accordance with Article 115 to amend the list of implants in Article 18.3? In this case, does the list in MDCG 2021-11 take precedence over the list in Article 18.3?
This is all very confusing!