What You Need To Know About the EU MDR & 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 and the IVDR in May 2022.

NOTE: You will see that some of our comprehensive MDR content that we have created refers to the May 2020 date of application.  The date of MDR application has moved to May 26th, 2021.  Articles that were written prior to the delay referenced the earlier date.  However, articles that you might read that reference the earlier date should be read taking the new date of May 2021 into consideration.  Read more here.

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 EU MDR provides detail on the responsibilities of the additional role of various Economic Operators in the medical device supply chain. This was examined in our recent article here.

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’s 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.

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

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?

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: info@acornregulatory.com or complete the form below and we will get back to you.

Further Reading

The issue of economic operators and the impact that MDR will have on them is a hot topic for discussion.  Orla Keane from our expert medical device team has written about the impact of MDR on economic operators here.

The 5 Responsibilities of the Person Responsible for Regulatory Compliance (PRRC) under MDR

As part of our series of articles looking at some of the changes on the way for medical device regulation under MDR, we are looking at the role of the Person Responsible for Regulatory Compliance (PRRC).

The role of QP is a familiar one for those working in the Pharma sector, but this is the first time in European medical devices legislation that a person is required to be appointed by a manufacturer to take specific responsibility for regulatory compliance of devices.  Read more here.

Note: (This page was updated in April 2020 to reflect the changes to the MDR implementation date)

About the Author
Orla Keane
Medical Devices Manager
An engineer by background, she has 15 years experience in medical devices. Prior to joining Acorn Regulatory, she spent over 12 years at the HPRA in various roles within the medical devices team. She was responsible for a team within post market surveillance and vigilance across various general and active implantable medical device product families. Orla also served as co-Chair of the Compliance and Enforcement working group in Brussels for many years. She has previous industry experience at an orthopaedic implant manufacturer. Orla currently assists Acorn Regulatory clients in a variety of areas including regulatory strategy, EU authorised representative support and preparation for MDR, particularly on the topic of post market surveillance. You can read medical device and related articles written by Orla Keane by clicking the link below.
Other articles by Orla Keane