This guidance document is written for authorised representatives, manufacturers and other economic operators, and intends to provide guidance on relevant requirements under the 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.
Where a manufacturer of a device is not established in a Member State, the device may only be placed on the Union market if the manufacturer designates a sole authorised representative (Article 11(1) MDR and IVDR).
Includes important topics such as:
-Designation and Mandate
-Registration and Verification obligations
-Minimum tasks & responsibilities of the AR
-Liability
-Termination of the mandate
-Change of AR
-Person Responsible for regulatory Compliance (PRRC)
-Market Surveillance