On 31 October 2022, the Medical Device Coordination Group (MDCG) published a guidance document concerning the EU Medical Device Regulation (MDR)(1) and the EU In Vitro Diagnostic Medical Device Regulation (IVDR).(2)

The MDCG document is addressed to authorised representatives, manufacturers and other economic operators and is intended to provide guidance on the relevant requirements of the MDR and the IVDR regarding the authorised representative – in particular, those of article 11 of the MDR and the IVDR.

The 10-page document provides specific guidance on the topics of:

  • designation and mandate;
  • registration and verification obligations;
  • minimum duties and scope of responsibilities of the authorised representative;
  • liability;
  • termination of mandate;
  • change of authorised representative;
  • interaction between the authorised representative and the person responsible for regulatory compliance;
  • market surveillance; and
  • transitional provisions.

Due to the prominent role of the authorised representative for manufacturers established outside the European Union, the explanations regarding the new regulations on liability as well as the responsible person according to article 15 of the MDR and the IVDR should, in particular, be carefully observed.

For further information on this topic please contact Eline van Nimwegen or Magdalena Kotyrba-Hagenmaier at Eversheds Sutherland LLP by telephone (+49 89 54565 0) or email ([email protected] or [email protected]). The Eversheds Sutherland LLP website can be accessed at www.eversheds-sutherland.com.

Endnotes

(1) Regulation (EU) 2017/745.

(2) Regulation (EU) 2017/746.