Authorised representative for medical devices: a comprehensive guide

This guide addresses the following topics to help you sell your medical device on the European market with an EC Rep:

• What is an European Authorised Representative for Medical Devices?
• Why do I need an European Authorised Representative for Medical Devices?
• What does an EC Rep do?
• How do I choose an EC Rep?
• EC Rep and the new Medical Device Regulation (MDR)
• Medical CE mark for devices after Brexit

What is an EU Authorised Representative for Medical Devices?

A European Authorised Representative (also known as an AR or EC REP) is a legal entity that acts as a liaison between a manufacturer based outside of the EU and a competent national authority (Ministry of Health) within the EU. The EU Authorised Representative for medical devices acts within the EU on behalf of the manufacturer. They ensure that the products being sold on the EU market comply with European Directives and/or Regulations.

Why do I need an Authorised Representative for a Medical Device?

Manufacturers of medical devices based outside of the EU must have an EC Rep (EU Authorised Representative for Medical Devices) to sell their products within the European Union. This applies to manufacturers of all medical devices (classified in four main categories according to the the EU MDR 2017/745):

• Class I
• Class IIa
• Class IIb
• Class III

What does an Ec Rep do?

An EC Rep (Medical Device Authorised Representative) verifies that medical devices sold on the EU market comply with specified European safety requirements. An EC Rep does not certify the products, but they review the documentation provided by the manufacturer and evaluate the certification procedures and safety of the products. They can carry out the following steps on behalf of the manufacturer as an AR for a medical device:

• Draw up the official EC Rep Mandate (agreement)
• Carry out a Technical Documentation review
• Carry out conformity assessments, when appropriate
• Confirm the medical device EUDAMED
• Draft a Declaration of Conformity
• Keep a file of the product’s Technical Documentation for potential inspection by EU regulators

Since EC Rep’s and manufacturers are jointly liable if the documentation is not according to European compliance standards, it is paramount that an EC Rep has a thorough understanding of relevant directives, regulations, standards and more.

How do I choose an EC Rep?

Choosing an EC Rep (Authorised Representative) is an extremely important part of the process. Since the EC Rep will have access to all files and information concerning the product, manufacturers often do not want to appoint an importer or distributor as their EC Rep. Appointing a party that is not economically or commercially involved with the products thus a favorable choice for manufacturers. Ensure regulatory success with AR Experts, part of Certification Experts, serving as your trusted EC REP.

EC Rep and the new Medical Device Regulation (MDR)

The Medical Device Regulation (MDR) 2017/745 is enforced as of May 26th, 2020. The responsibilities of the Authorised Representative for the Medical Device Regulation and manufacturers will change, because Technical Documentation will need to fulfill the requirements of the new regulation. Read more about how to get your file ready for the new Medical Device Regulation here.

CE marking medical devices after Brexit

The UK is no longer a part of the EU. The following manufacturers will need to make adjustments to continue selling their medical devices within the EU:

• Medical device manufacturers based in the UK
• Medical device manufacturers with an EC Rep based in the UK

In both cases, the manufacturer will need to appoint a new EC Rep/AR for medical devices within the EU to continue selling products on the European market. Whereas EU manufacturers or those with an EC Rep in the EU intending to market their medical devices in the UK must designate a UK Responsible Person (UKRP).

Do you have more questions about EC Rep’s for medical device compliance or changing policies due to the new MDR and/or Brexit? Certification Experts is ready to help, please do not hesitate to contact us.