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MDCG publishes guidance on legacy device registration

  • Posted by: inetika
  • Category: GLOBAL NEWS

The European Commission’s Medical Device Co-ordination Group (MDCG) (MDCG) has published two papers on registration of legacy devices on the Eudamed database:

The first of these highlights an inconsistency in the MDR text, stating that “On the one hand, Article 123(3)(d) lists the full Article 29 as being applicable from the application dates or, if Eudamed is not functional on time, six months after the date of publication of the notice referred to in Article 34(3). On the other hand, Article 123(3)(e) grants an additional 18-month transitional period for obligations contained in Article 29(4).” The paper clarifies that “the obligation for registration in Eudamed of device data elements listed in both part A, Section 2, and Part B of Annex VI, shall be applicable as from the timelines indicated in Article 123(3)(e) (meaning from 18 months after the general application date or, if Eudamed is not fully functional on time, from 24 months after the date of publication of the notice referred to in Article 34(3)).” Therefore, data elements have to be registered by November 2021 or May 2022 in the event of Eudamed not being functional.

The second document deals with registration of devices which can continue to be placed on the market under Medical Device Directive certificates after the relevant MDR application dates; so-called “legacy devices”. The MDR does not explicitly require that these legacy devices are subject to relevant UDI obligations. The MDR device registration requirements) make the Basic UDI-DI and UDI-DI the access keys for device-related information in the future Eudamed, which is reflected in the database design.

Therefore, any registration of a device is normally possible in Eudamed only if a proper Basic UDI-DI and UDI-DI are assigned to the device and registered in the database together with the other devicerelated data. In light of this the MDCG deems it appropriate to adapt the Eudamed design to allow the registration of legacy devices in the absence of a (Basic) UDI-DI. This is intended to prevent any technical constraint to the applicability of Art 120(3) for legacy device registration. A comprehensive description of the technical implications is provided in the Annex of the paper.

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