Questions and answers on obligations and related rules for the registration in EUDAMED of actors other than manufacturers, authorised representatives and importers. MDCG 2021-13 Rev.1

Il Medical Device Coordination Group (MDCG), il 12 Luglio 2021, ha pubblicato la revisione n.1 del documento MDCG 2021-13 “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” volto a rispondere a domande relative alla registrazione in EUDAMED di operatori diversi dai fabbricanti, mandatari ed importatori soggetti agli obblighi di cui all’articolo 31 del Regolamento (UE) 2017/745 sui dispositivi medici (MDR) e/o all’articolo 28 del Regolamento (UE) 2017/746 sui dispositivi medico-diagnostici in vitro (IVDR).

In questa revisione è stata aggiunta la domanda e risposta “Do importers who carry out the activities mentioned in Article 16 MDR/IVDR also need to register as manufacturers in EUDAMED?”