EU Representative
EU Authorised Representative (AR) is defined under MDR (EU) 2017/745 Art. 11 as a natural or legal person established in the EEA who has been formally designated in writing by a manufacturer outside the EEA to carry out certain tasks on their behalf in relation to MDR obligations.
AR obligations under MDR Art. 11:
- Register in EUDAMED and obtain SRN
- Keep technical documentation and EU Declaration of Conformity available and provide to authorities
- Coordinate all incident reports and FSCA with authorities
- Ensure the conformity assessment has been carried out
- Cooperate with market surveillance authorities
- AR name and address must appear on the product or packaging
Liability: the AR is jointly and severally liable with the manufacturer for non-conforming products.
Distinction:
- AR: represents the manufacturer to authorities
- Importer: independent economic operator who purchases and imports
Frequently asked questions
When does a manufacturer need an EU Authorised Representative?
Whenever a manufacturer is not established in the EEA and wishes to place medical devices on the EEA market. Without an AR, a non-EU manufacturer may not sell their product in the EEA.
Can the EU Authorised Representative affix the CE mark?
No. CE marking is affixed by the manufacturer or on their behalf. The AR coordinates but does not declare CE conformity - that remains the manufacturer's responsibility.
What happens if an EU Authorised Representative withdraws their mandate?
If the AR terminates the contract, the manufacturer must immediately designate a new one to continue operating in the EEA. Without a valid AR, no products may be sold in the EU.