Manufacturers not established in a Member State may place their medical device(s) on the EU market only if they have previously appointed a (single) Authorised Representative in accordance with Article 11 of the EU-Medical Devices Regulation (MDR).
The authorised representative may be any natural or legal person established in the EU. The manufacturer established outside the Union must mandate them in writing to perform certain tasks and duties on his behalf.
For manufacturers not established in the Union, the authorised person thus plays a crucial role in placing the medical devices on the EU market.
The authorised person can be held liable for defective products of the manufacturer if the general obligations of the manufacturer are not fulfilled. The authorised person is also subject to minimum qualification requirements, which are verified by the competent authorities. The manufacturer must indicate the name and address of the authorised representative on the label and accompanying documents. The abbreviated designation of the authorised representative shall be either “AR” for “Authorised Representative” or “EU-REP”for “European Representative”.
BEO BERLIN offers the EU-REP service after positive evaluation of the technical documentation for the relevant products. As soon as a service contract is concluded, a qualified BEO BERLIN employee will be registered as a European Authorised Representative in EUDAMED.
