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Partial U-turn on Eudamed delay

  • Posted by: inetika
  • Category: GLOBAL NEWS

As indicated in an earlier news item, while the EU ENVI Committee approved the second corrigenda for the MDR and IVDR, at the EPSCO Council meeting on 9 December, it is reported that the European Commission accepted a concession from the member states to ‘voluntarily’ introduce one Eudamed module by May 2020.

The module concerned is the one for registration of economic operators, which includes manufacturers, authorised representatives, importers and distributors, together with the issuing of Single Registration Numbers (SRNs).

There was initial confusion about the word ‘voluntary’ in respect of registration with this module, but this has now been clarified to mean that economic operators have the option to voluntarily register until six months after the Commission has announced that Eudamed is fully functional, at which time it will become mandatory.

Whether this will be the first of several modules to be introduced on a voluntary basis, as they become functional, remains to be seen.