First, note that the MDCG's interpretation is that the governing EU MDR legislation for legacy devices [Article 120(3)], "...
is not explicit in requiring..." that legacy devices be subject to the EU MDR's UDI requirements, and that it, "...
Lacks any explicit reference to UDI obligations for legacy devices...". Therefore, I would interpret that interpretation to mean that EU MDR UDIs aren't required for Article 120(3) legacy devices.
Note also that device registration (including UDI registration) in EUDAMED is not yet required due to the provisions of EU MDR Article 123(3)(d).
But in the event that you nonetheless desire to voluntarily apply EU MDR UDI provisions to your Article 120(3) legacy devices, and also to voluntarily register the legacy devices in EUDAMED during the current voluntary registration phase, then I'd say the best way to approach your question is to follow the EU MDR's usual UDI provisions even though, per the MDCG, they don't legislatively apply to your legacy device scenario.
Specifically, those generally require that the UDI information be registered in EUDAMED even before the UDI is on the labels. This is based on the EU MDR's Article 27(3) and Article 29 provisions stating that the UDI information needs to be in EUDAMED before the device is placed on the market, yet while also allowing devices to, until the end of the UDI labeling transitional periods [see Article 123(3)(f)], be placed on the market without a UDI on the label (noting that the UDI labeling transitional window has already closed for implantable and class III devices).
But again, remember that the MDCG has interpreted that the EU MDR's UDI requirements don't apply to legacy devices, and remember also that EUDAMED device/UDI registration is only voluntary at this time.
Finally, be sure to review your contract with your Notified Body if any is involved, as that may impose additional governing requirements on your scenario.
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Kevin Randall, ASQ CQA, RAC (Europe, Canada, U.S.)
Principal Consultant
Ridgway, CO
United States
© Copyright 2022 by ComplianceAcuity, Inc. All rights reserved.
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Original Message:
Sent: 06-Dec-2022 08:17
From: Anonymous Member
Subject: EUDAMED database
This message was posted by a user wishing to remain anonymous
Hello,
we plan to enter our legacy devices in the EUDAMED database. Do you know if we can enter the UDI-DI in the database even if we do not have the UDI on the label?
Thank you