The Role of the EU AR
In this second article in our series, we look in more detail at the role of Authorised Representative required for manufacturers based outside of Europe. It was established in the Directives to act as a contact point within Europe who could act on behalf of the manufacturer. The scope of the role of Authorised Representative has been expanded under EU MDR compared to previously, and details may be found in Articles 11 and 12 of Regulation (EU) 2017/745.What Is An EU Authorised Representative?
The EU authorised representative is defined as: ‘any natural or legal person established within the Union who has received and accepted a written mandate from a manufacturer, located outside the Union, to act on the manufacturer’s behalf in relation to specified tasks with regard to the latter’s obligations’ under the Regulation. The existing MEDEV on authorised representatives has essentially been incorporated into the regulation and there is also an article that describes the process to change an authorised representative.
What Are The EU Authorised Representative Obligations under 2017/745?
The manufacturer must be based outside of the EU and there is a new requirement for there to be a written mandate to define the designation of authorised representative and for this to be signed and accepted by both manufacturer and authorised representative. The authorised representative must:- verify the declaration of conformity, conformity assessment, technical documentation, registration requirements and manufacturer obligations.
- keep available a copy of the declaration of conformity, technical documentation and certificates.
- establish systems for the provision of information to CAs and manufacturers; CAPA; registration; complaint handling; establishment, maintenance, termination of mandate; person responsible for regulatory compliance.
We Can Help
Companies need to ask themselves the following questions:- Are you a manufacturer based outside of Europe?
- Do you have an Authorised Representative appointed in Europe?
- Are you a manufacturer with a UK based Authorised Representative looking to make a change in preparation for Brexit?
- Are you aware of your responsibilities under EU MDR?
- Do you have the resources and systems in place to fulfill your obligations under the new Regulations?