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MDCG updates Q&A guidance on Eudamed registration of non-economic operator actors

  • Posted by: inetika
  • Category: GLOBAL NEWS

MDCG 2021-13 rev.1, ‘Questions and answers on obligations and related rules for the registration in EUDAMED of actors other than manufacturers, authorised representatives and importers subject to the obligations of Article 31 MDR and Article 28 IVDR’, has now been published by the Medical Device Coordination Group (MDCG), adding a further question to the document.

The new question relates to: ‘Do importers who carry out the activities mentioned in Article 16 MDR/IVDR also need to register as manufacturers in EUDAMED?’, to which the answer is ‘Yes’ if the importer carries out activities under MDR/IVDR Article 16(1), but ‘No’ if he carries out activities under MDR/IVDR Article 16(2).

The guidance provides answers in relation to actors including manufacturers of:

  • only custom made devices;
  • only legacy devices;
  • only ‘old’ devices;
  • system and procedure pack producers
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