European Authorized Representative for
Medical Device and IVD Companies
Overview
If your company has no physical presence in the EU, EU medical device law requires you to appoint an EU Authorized Representative (EU AR or EC REP) located in the EU to act as your liaison with national competent authorities.
Who needs an EU Authorized Representative?
Any manufacturer without an EU establishment that wants to place medical devices or in vitro diagnostics (IVDs) on the EU market must appoint and retain an EU AR for as long as devices are sold in the EU.
EU Authorized Representative key responsibilities
An EU AR acts as the manufacturer’s local contact for competent authorities and must:
- Support required device/IVD registrations.
- Be listed on product labeling, outer packaging and/or Instructions for Use (name and address next to the EC REP logo).
- Make a current Technical File/Declaration of Conformity available to authorities on request.
- Assist with incident reporting and Field Safety Corrective Actions (FSCAs), working with the manufacturer and distributors.
- Provide ad hoc regulatory consulting as agreed.
Tip: Appointing a distributor as EU AR is possible but not recommended; choose an independent regulatory-focused representative rather than a sales-minded distributor.
Why choose MDRA as your EU Authorized Representative?
MDRA offers a premium EU AR service with global regulatory partnership features:
- Review of Technical File and handling of required registrations and authority queries.
- Secure online access to regulatory documents, labeling, language requirements, guidance, etc.
- Broad experience registering thousands of devices for efficient processing.
- Regular EU regulatory updates for clients.
- Offices in Europe plus presence in the US and UK.
Liability under the MDR and IVDR
Under the MDR/IVDR, EU ARs assume greater liability and may be held jointly and severally liable for defective devices. Expect increased monitoring of your compliance by your AR.
Brexit effects
Post-Brexit: companies selling in the UK must appoint a UK Responsible Person (UKRP). UK-based firms selling in the EU likewise need an EU AR.
Consequences of not appointing an EU AR
A Notified Body will not issue a CE certificate without an EU AR. Failure to appoint an AR may prevent market entry or lead to shipments being stopped at the border.
Inspections and changing representatives
- Competent Authorities may inspect an EU AR to verify its access to client documentation and compliance processes.
- You may change EU ARs without invalidating existing approvals, but relabeling and managing product already in market will be required.
UK Responsible Person (UKRP)
Egypt Registration Holder (ERH)
