07.11.2022
To the attention of authorised representatives, manufacturers, economic operators and all stakeholders
Please be informed that on 31 October 2022, the European Commission published the MDCG 2022-16 Guidance: Guidance on Authorised Representatives Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR)
This guidance document is written for authorised representatives, manufacturers and other economic operators, and intends to provide guidance on relevant requirements under the two Regulations.
Where clarification is already covered by other MDCG guidances, this guidance on authorised representatives includes a reference.
The requirement to have an authorised representative is not applicable to devices intended for clinical investigation (MDR) or performance study (IVDR).
To this end, Article 62(2) MDR and Article 58(4) IVDR state that ‘where the sponsor of a clinical investigation or performance study is not established in the Union, that sponsor shall ensure that a natural or legal person is established in the Union as its legal representative’
As the legal representative is not defined as the authorised representative, these requirements are not further included in this guidance.
The announcement of the European Commission is available online at: https://health.ec.europa.eu/latest-updates/mdcg-2022-16-guidance-authorised-representatives-regulation-eu-2017745-and-regulation-eu-2017746-2022-10-31_en
download document …