First guidance documents supporting IVDR and MDR released by the European Commission
Posted on 02.05.2018
- Draft guidance on Basic UDI-DI provides a clarification on the notion of Basic UDI-DI, its use in relevant documentation and the factors triggering UDI-DI changes.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.
- 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).
- 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.
- 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.