MDCG 2021-15 : Application form to be submitted by a conformity assessment body when applying for designation as notified body under the medical devices regulation (MDR) – July 2021 MDCG 2021-16 : Application form to be submitted by a conformity assessment body when applying for designation as notified body under the in vitro diagnostic devices regulation (IVDR) – July 2021

3 Sep 2021 | All the News, MDCG

Theme Designation as notified body Target Audience Conformity assessment bodies Products concerned MD & IVD Documents mentioned MDR (EU) 2017/745 IVDR (EU) 2017/746 These MDCG guides (15 & 16) correspond to the forms to be completed by conformity assessment...

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 – June 2021

9 Jul 2021 | MDCG

Theme EUDAMED Target Audience Actors other than manufacturers, authorised representatives, and importers Products concerned MD and IVD Documents mentioned MDR (EU) 2017/745 IVDR (EU) 2017/746 MDCG 2019-5 MDCG 2021-3   This document provides information on the...