Authorised representatives (EU REPs)
EU REP obligations are defined in MDR Article 11 and IVDR Article 11. Definitions appear in MDR Article 2(32) and IVDR Article 2(29).
This site provides general information only and does not constitute legal or regulatory advice. Always consult the official regulation text and, where appropriate, a qualified regulatory professional.
What is an authorised representative?
An authorised representative (commonly called an EU REP) is any natural or legal person established within the EU who has received and accepted a written mandate from a non-EU manufacturer to act on the manufacturer's behalf in relation to specified tasks.
The EU REP acts as the legal point of contact within the EU for the manufacturer. Competent authorities and users can address the EU REP in place of the manufacturer for all regulatory matters covered by the mandate.
When is an EU REP required?
An EU REP is mandatory whenever a manufacturer that is not established in the EU (including manufacturers established in Switzerland post-2021, UK post-Brexit, or any other non-EU country) wishes to place a device on the EU market.
There is no exception to this requirement. A non-EU manufacturer who places a device on the EU market without designating an EU REP is committing a regulatory violation, and competent authorities can prevent market access.
UK-established manufacturers who previously relied on their UK establishment to access the EU market now require an EU REP. The UK-EU MRA for medical devices does not restore automatic mutual recognition — a formal EU REP is required.
What the EU REP must do
The mandate between the manufacturer and the EU REP must specify, at minimum, that the EU REP will:
- Register in EUDAMED and receive a Single Registration Number (SRN)
- Verify that the EU Declaration of Conformity and Technical Documentation have been drawn up and, where applicable, that an appropriate conformity assessment procedure has been carried out
- Keep available a copy of the Technical Documentation and the DoC for the period required (minimum 10 years; 15 years for implantables)
- Comply with EUDAMED registration obligations in relation to devices for which it is the authorised representative
- Inform the manufacturer immediately if there are indications the device may not conform to MDR/IVDR requirements
- Cooperate with competent authorities on preventive or corrective actions, including product recalls and FSCAs
- Forward to the manufacturer any complaints or reports from healthcare professionals, patients, or users about suspected incidents relating to the device
- Terminate the mandate if the manufacturer acts contrary to MDR/IVDR, and notify the relevant competent authority and notified body
Legal liability of the EU REP
The EU REP shares joint and several liability with the manufacturer for defective devices. This is explicit in MDR Article 11(5) and means:
- Competent authorities can pursue the EU REP directly for compliance failures
- The EU REP cannot disclaim liability by pointing solely to the manufacturer
- The EU REP should therefore carry out genuine due diligence before accepting the mandate — not simply act as a "letterbox"
In practice, EU REP service providers typically conduct technical reviews, QMS audits, and ongoing monitoring of the manufacturer's compliance as part of their mandate acceptance process.
What the EU REP is NOT
The EU REP role is sometimes misunderstood. The EU REP:
- Is not the importer (unless they happen to also import the device)
- Is not responsible for the actual conformity assessment — that remains the manufacturer's responsibility
- Is not the distributor in the supply chain (though they may be commercially involved)
- Does not issue the CE mark or Declaration of Conformity (the manufacturer does)
- Is not a replacement for a notified body
Who can be an EU REP?
Any natural person (individual) or legal person (company) established within the EU/EEA. In practice, EU REP services are commonly provided by:
- Regulatory affairs consultancies that specialise in EU REP services
- EU-based subsidiary companies of the non-EU manufacturer
- Specialist EU REP service companies offering managed services
The EU REP does not need to be established in any particular Member State — they can be established anywhere within the EU/EEA.
Labelling requirements
The EU REP's name, registered trade name or trademark, and registered address must appear on:
- The device
- The packaging, or
- A document accompanying the device
This is a hard requirement — devices placed on the EU market by a non-EU manufacturer must display EU REP contact details. The EU REP details must also be registered in EUDAMED.
Changing EU REPs
If a manufacturer terminates one EU REP and appoints another, the transition must be managed carefully:
- The outgoing EU REP must cooperate with the transition and provide access to all documentation held under the mandate
- The new EU REP must update their details in EUDAMED and notify relevant competent authorities
- EUDAMED records, certificates (if any), and labelling must all be updated
- The notified body (if applicable) must be notified of the change
MDR/IVDR do not specify a mandatory notice period, but MDCG guidance recommends managing transitions carefully to avoid gaps in regulatory coverage.
EU REP obligations summary
| Obligation | MDR reference | IVDR reference |
|---|---|---|
| Accept written mandate from non-EU manufacturer | Art. 11(1) | Art. 11(1) |
| Register in EUDAMED | Art. 30 | Art. 27 |
| Keep Technical Documentation and DoC available | Art. 11(3)(b) | Art. 11(3)(b) |
| Cooperate with competent authorities | Art. 11(3)(e) | Art. 11(3)(e) |
| Respond to requests from competent authorities | Art. 11(3)(f) | Art. 11(3)(f) |
| Terminate mandate if manufacturer is non-compliant | Art. 11(4) | Art. 11(4) |
| Display name/address on device labelling | Art. 11(2) | Art. 11(2) |
Related pages
- Who needs to comply?
- Manufacturers
- Importers
- Distributors
- EUDAMED registration
- Non-EU & third-country access
Official references
| Reference | Description |
|---|---|
| MDR Art. 2(32) | Definition of authorised representative |
| MDR Art. 11 | Obligations of authorised representatives |
| IVDR Art. 2(29) | Definition of authorised representative (IVDR) |
| IVDR Art. 11 | Obligations of authorised representatives (IVDR) |
| MDCG 2021-17 | Guidance on the role of economic operators |