Good day Anon,
That is a good question which I am not sure you will find a definitive answer for implant cards implementation themselves, but for UDI it is quite clear. If you read through Article 120 for the transition period there are a number of items which need to be performed after a few days from now, even if there is a valid MDD EC Certificate. Implant cards fall under Article 18 which is not explicitly stated or identified in Article 120. However, there are many articles which are "quality system" requirements, which might be expected to comply. The definitive answer you should get is from your Notified Body and/or local Competent Authority as there are current "expectations" for what activities must be implemented after May 2021 for implant cards and those which are relegated under the EU MDD certificate. In the meantime, you should transition as quickly as you can because the whole point of the EU MDR being published May 2017 was for companies to transition in that timeframe, not after May 2020, or now May 2021. So I do not think companies will get much sympathy from Notified Bodies who have not been working on these activities for the last 4 years ...
Also, regardless of content of implant cards as they may apply according to Article 18 or transition activities from Article 120, Class III devices according to Article 123 should have UDI fully implemented by 26 May 2021. It has been stated a few times in this forum, UDI is required by the dates of Article 123 whether EUDAMED is fully functional or not. The product identification and traceability for UDI must be implemented according to Article 123 - including all locations where UDI is required on the product labelling. And product labelling does include implant cards.
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Richard Vincins RAC
Vice President Global Regulatory Affairs
Oriel STAT A MATRIX - ENTERPRISE
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Original Message:
Sent: 18-May-2021 21:40
From: Anonymous Member
Subject: Patient Implant Card
This message was posted by a user wishing to remain anonymous
Hi All,
I just wanted to get an answer regarding the implementation of the EU MDR Implant Card. We are a class III/Implantable device manufacturer and currently have a CE certificate under the directive, which is valid until May 2024. We have an existing implant card that we've been using for years that lacks the information (UDI-DI, UDI barcode, etc) that is required in the EU MDR. Since we are still under the directive and not MDR compliant yet, do we need to comply with the EU MDR implant card requirement?
Your answers are greatly appreciated!
Thank you so much.