Your guide to European authorised representatives

What we do and how we can help you


Thinking of exporting to Europe? You’ve probably got your marketing, packaging and distribution planned. But have you considered the complex regulatory requirements facing non-European medical device manufacturers? Here are some guidelines to help you succeed in Europe.

What is a European authorised representative and why do I need one?

A European authorised representative serves as a legal entity designated by non European Union (EU) manufacturers to represent them in the EU and ensure their compliance with European directives.

As clarified in the medical devices directive amendment (93/42/EEC), it is required that alongside the CE mark all manufacturers must have an authorised representative. The authorised representative serves as a contact point with the EU member states competent authorities.

The authorised representative serves as a neutral party between the competent authorities and non EU manufacturers. They must ensure the manufacturer’s compliance with the conformity assessment procedure set out in the European directives which apply to the manufacture’s product. The authorised representative is responsible for resolving problems or questions regarding the manufacturer’s product. Therefore the manufacturer must place the authorised representative’s contact information on all products for future contact with competent authorities.

Role and responsibilities:

  • Observes manufacturer’s compliance with conformity assessment procedure set out in the European directives which apply to the product
  • Ensure law is met by having class I medical devices registered with competent authorities before going to market
  • Ensure their contact information is available to manufactures and placed on all products they are representing, thus acting as primary contact for EU authorities
  • Keep product’s technical file available at any time for EU member state authorities and maintain confidentiality with manufacturer’s sensitive product information, releasing only to appropriate authorities when called upon
  • Gives you authorisation to place our name and address on your device labels, packaging and instructions
  • Available to interact between you and EU competent authorities
  • Responsible for incident and field safety corrective action (FSCA) reporting to competent authorities, in cooperation with you and your distributors
  • Protects the confidentiality of your documentation. The European authorised representative can only show technical documentation to competent authorities as required by law
  • Represents you to the European Commission for consultation in case of withdrawal of a medical device by a member state(s)
  • Maintains reports concerning critical evaluation of all data collected during clinical evaluations for review by competent authorities
  • Notify EU authorities of all major incidents pertaining to products
  • Understand all EU regulations from each EU member state as well as four European Free Trade Association (EFTA) states, and provide notification of changes and amendments to directives that affect individual products

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