This guide addresses the following topics to help you sell your medical device on the European market:
- What is an authorised representative?
- Why do I need an authorised representative?
- What does an authorised representative do?
- How do I choose an authorised representative?
- Authorised representatives and the new Medical Device Regulation (MDR)
- CE marking medical devices after Brexit
What is an authorised representative?
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 authorised representative acts within the EU on behalf of the manufacturer. They ensure that the products being sold on the EU market comply with European Directives.
Why do I need an authorised representative?
Manufacturers of medical devices based outside of the EU must have an authorised representative 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 authorised representative do?
An authorised representative verifies that products sold on the EU market comply with specified European safety requirements. An AR 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:
- Draw up an authorised representative agreement
- Carry out a technical documentation review
- Carry out conformity assessments, when appropriate
- Register the medical device with the competent authority (when the medical device is a class I device)
- Draft a declaration of conformity
- Keep a file of the product’s technical documents for potential inspection by EU regulators
Since authorised representatives and manufacturers are jointly liable if the documentation is not according to European compliance standards, it is paramount that an AR has a thorough understanding of relevant directives, standards and more.
How do I choose an authorised representative?
Choosing an authorised representative is an extremely important part of the process. Since the AR will have access to all files and information concerning the product, manufacturers often do not want to appoint an importer or distributor as their authorised representative. Appointing a party that is not economically or commercially involved with the products (such as Certification Experts) is thus a favorable choice for manufacturers.
Authorised representatives and the new Medical Device Regulation (MDR)
The Medical Device Regulation (MDR) 2017/745 will be fully enforced as of May 26th, 2020. The responsibilities of both authorised representatives and manufacturers will change, because technical documents 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 authorised representative based in the UK
In both cases, the manufacturer will need to appoint a new authorised representative within the EU to continue selling products on the European market.
Do you have more questions about ARs for medical devices or changing policies due to the new MDR and/or Brexit? Certification Experts is ready to help.