In which cases do you need to assign the EU Authorised Representative for Medical Devices?
Read further to know more about this subject.
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Certification Company – Your reliable EU Authorised Representative
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.
An EU Authorised Representative (or EU Responsible Person) is a natural or legal person who acts on behalf of the manufacturer in relation to the CE legislation:
- keeps all technical documentation available for inspection,
- takes care of any incident reporting,
- ensures compliance with constant regulatory updates and so on.
Do you buy products outside the EU to resell it afterwards in the EU? Then you will be seen as an importer with all the related obligations. So, an appointing of the EU Authorised Representative may be beneficial to the importer as well (eventhough he is located in the EU) to have less liabilities to the European Commission, Authorities and Notified Bodies.
EU Authorised Representative Responsibilities and Services
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.
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