Authorised representative

The authorised representative has the legal responsibility for defective devices on an equal basis with the manufacturer, if the defects are due to the manufacturer not having fulfilled its obligations.

This can entail, inter alia, liability to pay compensation to users and patients who have been injured, penalties and punishments.

The authorised representative is therefore a role of responsibility which entails extensive obligations.

Point of contact for authorities and users

The authorised representative must be a point of contact for authorities and users within the EU/EEA for the devices in question, which means being able to answer on the manufacturer’s behalf. The authorised representative’s address must be stated on labelling and instructions for use.

Division of responsibility

It is not the authorised representative which is responsible for placing devices on the Union market; this is the responsibility of the importer. However, in practice, it is clear that many authorised representatives also assume the role of importer, and therefore play a double role.

The manufacturer must:

• draw up a written mandate which regulates responsibility which must be accepted in writing by the authorised representative
• give the authorised representative every opportunity to perform the tasks that it must perform in order to fulfil its responsibilities
• take responsibility for areas that the authorised representative is unable to control, such as device design, quality management system, preparation of documentation and conformity assessment.

The authorised representative must:

• ensure that the manufacturer fulfils its obligations
• register its data in EUDAMED
• retain a copy of the declaration of conformity, technical documentation and any certificates from the notified body for at least ten years after the last placing on the market
• immediately forward all reports on incidents and complaints concerning the devices to the manufacturer, including after a change of authorised representative
• present information and documentation upon request to the competent authority
• ensure that the competent authority has access to samples or devices upon request
• co-operate with competent authorities in order to eliminate risks associated with devices
• co-operate with the manufacturer and incoming authorised representative in the event of a change in authorised representative.

If the manufacturer does not fulfil its responsibility

The authorised representative must terminate the agreement if the manufacturer has failed to fulfil its obligations, and immediately notify the competent authority of the termination of the mandate, as well as the reasons for this. Where appropriate, the notified body must also be notified.