If your organisation does not have a physical location in Europe, you are required, by the medical device regulation MDR 2017/745, to appoint an EU Authorised Representative (AR) or (EC REP) to represent your company to the European authorities. You must retain an AR for as long as you market your medical device in Europe. This legal obligation is effective for the marketing of all classes of medical devices, whether or not a notified body is required for CE marking. If you do not appoint a representative, your products destined for the EU market may be stopped at the border.

Who is the AR?

An AR is any natural or legal entity established within the European Union who has received and accepted a written mandate from a manufacturer located outside the EU, to act on the manufacturer’s behalf in relation to specified tasks with regard to the manufacturer’s legal obligations under the Regulations for particular device families. (A manufacturer may have more than one authorised representative!)

What is the written mandate?

The mandate is the agreement document signed by the authorised representative and the manufacturer declaring the specific tasks to be performed by the AR on behalf of the manufacturer. The Authorised Representative will assume and share appreciably more risk and liability than currently assigned under the medical device directive. The MDR stipulates a list of minimum requirements for mandate declaration and agreement.

What are an AR’s specific legal obligations according to the regulation?

As per Article 11 (3), the agreed mandate shall require, and the manufacturer shall enable, the authorised representative to perform the following minimum tasks in relation to the devices that it embodies:

  • The AR must verify that the EU declaration of conformity and technical documentation have been prepared and, when applicable, that an appropriate conformity assessment procedure has been performed by the manufacturer;

This task requires the AR is allowed access to the manufacturers DoC and TFs for the device family as specified and has the applicable expertise to determine compliance

  • The AR must keep available a copy of the technical documentation, the EU DoC and, if applicable, maintain a copy of the relevant certificate, including any amendments and supplements, issued according to Article 56 (Certificates of Conformity), at the disposal of competent authorities (CA) for the period of 10 years (15 years for implantables) after the last device has been placed on the market

The manufacturer must enable access for the AR to the current DoC, TF and certificates of conformity for the devices specified and all updates for up to 15 years, including the ability to produce the current version when requested by the CA.

  • The AR must register with EUDAMED prior to a conformity assessment requiring notified body involvement and verify that the manufacturer has complied with the EUDAMED registration obligations for UDI for all device classes
  • The AR, when requested, must provide the CA with all the information and documentation necessary to demonstrate the conformity of a device, in the official language determined by the Member State

The mandate should specify who is responsible for obtaining and updating the translated conformity documentation and how the AR will be allowed access

  • The AR is required to forward to the manufacturer any request by a competent authority for samples, or access to a device and verify that the competent authority receives the samples or is given access to the device;

The mandate should include methods of communication and timeliness of appropriate actions

  • The AR must cooperate with the competent authorities on any corrective or preventative action taken to eliminate or, mitigate the risks posed by the devices for which they are responsible

As the AR will be held jointly and separately liable for defective medical devices, one can assume that an AR will be monitoring a manufacturers compliance very thoroughly and insistent on complete cooperation with CAs

  • The AR must immediately inform the manufacturer about complaints from healthcare professionals, patients and users about suspected incidents related to a device for which they have been designated

The AR and manufacturer will need processes and systems for monitoring, capturing, analysing and exchanging complaints data

  • The AR is obligated to terminate the mandate if the manufacturer acts contrary to its legal obligations as per the Regulation.

The change of authorised representative requires an agreement that defines the arrangements between the manufacturer and both the outgoing and the new authorised representative (Article 12). Changing an AR may be costly as the AR details are included in the labelling.

Be mindful that Article 11(4) also specifies the tasks that a manufacturer cannot delegate via the mandate agreement to their AR. This includes requirements related to the device design, QMS system, clinical evaluation, writing technical documentation and labelling; as these are the individual responsibilities of the manufacturer.

Does having an Authorised Representative impact labelling?
The manufacturer must include the name and address of the AR on the product label, outer packaging and/or Instructions for Use. This information of the AR should be shown next to the official logo.

Are Authorised Representatives Audited?

The Competent Authority can audit an AR at any time, including unannounced, to determine if they understand their role, have direct access to the manufacturers documentation and have systems in place to ensure fulfilment of its role according to their mandate.

What about Brexit?

Following the UK’s departure from the European Union, anyone based outside the United Kingdom (EU or non-EU) will require a UK-based responsible person to act on behalf of the manufacturer to initiate or continue selling in the UK. This includes registering with the MHRA before the device is placed on the UK market. Furthermore, UK-based companies will require an EU-based AR, as illustrated above, to initiate or continue selling in the EU. 

Non-European Medical Device Manufacturers:

Your choice for authorised representative is critical for initiating and/or continuing the successful marketing of your devices within the European community.

  • Your AR will dictate and manage your relationship with the competent authorities.
  • Your appointed AR must be willing and capable to share and administer legal obligations under the Regulation to support your products.
  • Are you ready to begin communicating with and sharing your technical documentation as obligatory for the next 10 -15 years?

Kimyoung@instem.com

K Young

References:

Factsheet for ARs, importers and distributors https://ec.europa.eu/health/sites/health/files/md_newregulations/docs/importersdistributors_factsheet_en.pdf

MDR overview https://ec.europa.eu/health/md_newregulations/getting_ready/authorised_representatives_importers_distributors_en

Actor registration module: https://ec.europa.eu/health/md_eudamed/actors_registration_en

Actor roles: https://ec.europa.eu/health/sites/health/files/md_eudamed/docs/md_actor_roles_srn_en.pdf

UK Responsible person: https://www.legislation.gov.uk/ukdsi/2019/9780111179260/pdfs/ukdsi_9780111179260_en.pdf#page=39

Photo by Guillaume Périgois on Unsplash

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