European representation
EU Authorised Representative Support for Non-EU Manufacturers
An EU-established regulatory interface for manufacturers operating from outside the Union.
Article 11 MDR
A manufacturer not established in an EU Member State must designate a sole Authorised Representative for covered devices placed on the Union market.
Written mandate
The role is established through a written mandate accepted by the Authorised Representative and covering the regulatory tasks assigned under the MDR.
Representation and manufacturer responsibility are different
Manufacturer obligations remain with the manufacturer. The EU Authorised Representative performs the tasks defined by the Regulation and mandate.