New EU Medical Device Regulations (EUDR) & The Authorised Representative
Two new EU Regulations entered into force on 26th May 2017. Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in-vitro diagnostics (IVDR) replace the current three Directives, which have been in place since the early 1990s. There is a transition period for the implementation of the various elements of the new regulations, with MDR becoming fully operational in May 2020 the IVDR in May 2022.
Now is the time for those impacted by the changes to the medical devices regulatory landscape to prepare for implementation of the new regulations. In the current Directives, the legal responsibility for medical devices placed on the market lies firmly with the legal manufacturer of the device. The EUDR provides detail on the additional roles responsibilities of various Economic Operators in the medical device supply chain. This was examined in our recent article here. 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 EUDR compared to previously, and details may be found in Articles 11 and 12 of Regulation (EU) 2017/745.
What is an Authorised Representative?
The 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’s new? Authorised Representative Obligation 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 provision of information to CAs and manufacturers; CAPA; registration; complaint handling; establishment, maintenance, termination of mandate; person responsible for regulatory compliance.
In addition, the Regulation stipulates that the authorised representative is legally liable for defective devices in the event that a manufacturer established outside the Union has not complied with its general obligations
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 EUDR? Do you have the resources and systems in place to fulfil your obligations under the new Regulations?
If you would like to speak to us about Authorised Representative services or seek our advice then call us on 00353 52 61 76706, email us: email@example.com or complete the webform below and we will get back to you.