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EU publishes guidance on Authorised Representatives

  • Posted by: inetika
  • Category: GLOBAL NEWS

The European Commission’s Medical Device Coordination Group (MDCG) has published a new guidance on Authorised Representatives under the Medical Device Regulations (MDR, 2017/745 and IVDR, 2017/746), replacing the January 2012 MEDDEV 2.5/10 ‘Guideline for Authorised Representatives’ which applied to authorised representation under the Medical Device Directives (MDD and IVDD).

The new guidance is MDCG 2022-16 ‘Guidance on Authorised Representatives Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR)’, providing authorised representatives, manufacturers and other economic operators advice on relevant requirements under the Regulations.

The guidance clarifies that during the transition for legacy devices to MDR/IVDR compliance, the requirements for authorised representatives under the Directives continue to apply, although the MDR/IVDR requirements concerning market surveillance, post-market surveillance, vigilance and registration of economic operators and devices apply, and thus any MDD/IVDD authorised representative mandates should be updated to include these new aspects, per Article 11(3)(c)-(g).

Copies of the new guidance can be accessed from here.