According to the EU MDR (European Union Medical Device Regulations), medical device manufacturers must, in some circumstances, appoint a European Authorised Representative in order to obtain CE certification for their products so they can be sold in Europe.
What is a European Authorised Representative, though?
According to the definition in EU regulations, an Authorised Person must be a “natural or legal person” in the EU. The main role of an Authorised Representative is to represent the manufacturer in dealings with EU regulators.
If you are a European-based medical device manufacturer, you will deal directly with regulators. There is no need for a middle entity.
The role of a European Authorised Representative only applies if you are a manufacturer outside the EU and want to sell your medical device products in Europe.
Note there is also no requirement to appoint a European Representative if the manufacturer is in the European Economic Area (Norway, Liechtenstein, and Iceland) or the European Free Trade Association (Switzerland).
Outside of these locations and the EU, a European Authorised Representative is a regulatory requirement.
The Roles and Responsibilities of European Authorised Representatives
European Authorised Representatives have a number of responsibilities under EU regulations when they agree a mandate with a medical device manufacturer. Those roles and responsibilities include:
- Help obtain CE certification
- Review the manufacturer’s Technical File and verify the Declaration of Conformity
- Retain an up-to-date copy of the manufacturer’s CE Declaration of Conformity or Technical File so it can be inspected on request
- Conduct ongoing reviews of the manufacturer’s compliance with EU medical device regulations
- Communicate to the manufacturer about any incident reports from users and product complaints
- Help with Field Safety Corrective Action. This involves action taken by a medical device manufacturer to recall products being sold in Europe. Recalls can be for medical or technical reasons.
In addition to the above, the name and contact details of the European Authorised Representative must be included on the labels of products sold in Europe. This includes the outer packaging, product labels, and instructions for use.
Has the Role of Authorised Representative Changed Under the New EU MDR?
The role of European Authorised Representative pre-dates the EU’s current regulations, but the new EU MDR places greater responsibilities on Authorised Representatives. These greater responsibilities increase the level of risk as European Authorised Representatives are now jointly liable for medical device products that are defective.
The impact of this change in the rules is that European Authorised Representatives are now more likely to closely monitor manufacturer compliance than they would have previously.
The new EU MDR also places a requirement on European Authorised Representatives to terminate their agreement with a manufacturer if the manufacturer doesn’t remain in compliance with EU regulations.
These new requirements have the potential to increase costs for manufacturers as European Authorised Representatives take into account the enhanced levels of business risk involved.
Do You Need Medical Device Regulatory Assistance?
If you have a query about getting a medical device product approved for use in the EU, or if you need guidance on FDA regulations, get in touch with us at Arrotek.