First guidance documents supporting IVDR and MDR released by the European Commission

Posted on 02.05.2018

The first guidance documents endorsed by the Medical Device Coordination Group (MDCG) and supporting the upcoming IVD Regulation and MD Regulation are now published at the Commission website:

  1. Draft guidance on Basic UDI-DI provides a clarification on the notion of Basic UDI-DI, its use in relevant documentation and the factors triggering UDI-DI changes.

Basic UDI-DI has a relevant regulatory role since it is the main access key of information in Eudamed: it connects all associated device identifiers (UDI-DIs) with the information in the various modules of Eudamed. The Basic UDI-DI should also be indicated on regulatory documents however it does not appear on the product label.

 

  1. Another MDCG approved document provides a description of expected requirements and criteria of the future nomenclature. The mapping document does not specify which nomenclatures are considered.

 

DG GROW established a way to publish relevant documents which reflect the views of various working groups (participated by Member State experts and by industry representatives as observers).

  1. DG GROW UDI task force released its concept on a possible architecture of the UDI database. This document divides the UDI core data elements listed in Annex VI of both MDR and IVDR into three groups: attributes whose change would trigger a new Basic UDI-DI, a new UDI-DI or a new packaging UDI-DI.
  2. A third document which also reflects the views of the DG GROW UDI task force includes the definitions, descriptions and formats of the UDI core elements listed in Annex VI Part B of MDR and IVDR.

 

More relevant guidance documents are expected to appear at DG GROW’s dedicated website throughout the implementation phase.

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