Authorized Representative (EU)
Legal entity established in the EU that represents a non-EU manufacturer for MDR/IVDR purposes.
Definition
The Authorized Representative is mandated by a written contract, registered in EUDAMED, and shares specific liabilities with the manufacturer. They hold technical documentation, interface with competent authorities, and handle vigilance reports. Non-EU manufacturers must designate an authorised representative under MDR and IVDR Article 11 through a written mandate. The representative must verify the declaration of conformity and technical documentation, keep documents available to authorities, cooperate on corrective actions and register in EUDAMED. They are jointly and severally liable with the manufacturer for defective devices, so they must also have their own PRRC.What this means in practice
Choosing a competent EC REP with strong notified-body and competent-authority relationships is a strategic - not just administrative - decision.Examples
- A US-based MedTech manufacturer appoints a German Authorized Representative to place their Class IIa surgical device on the EU market.
- An EU competent authority contacts the Authorized Representative of a Japanese medical device company to request clarification on a vigilance report.
- A manufacturer updates their technical documentation in response to a notified body audit, and the Authorized Representative ensures they have the latest version.
- •Misunderstanding the Authorized Representative as a mere postal address, rather than a key regulatory actor with legally defined responsibilities.
- •Failing to provide the Authorized Representative with full access to technical documentation, hindering their ability to perform required checks.
- •Assuming the Authorized Representative bears sole liability, whereas liability is shared with the manufacturer for non-compliance.
- •Not establishing a clear, written mandate with defined responsibilities, as required by EU MDR Article 11(3).
Frequently asked questions
Related terms
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· Hand-selected related conceptsRegulation (EU) 2017/746 governing in vitro diagnostic medical devices in the EU.
Regulation (EU) 2017/745 governing medical devices in the European Union.
UK-based equivalent of the EU Authorized Representative required for non-UK manufacturers placing devices on the GB market.
More in Regulatory
· Same categoryFDA submission demonstrating a device is substantially equivalent to a legally marketed predicate.
Two alternative disclosure mechanisms in a 510(k) submission, a Summary is public on FDA's website; a Statement promises to share Safety & Effectiveness info on request.
Formal mechanism to ask FDA whether a product is a device and, if so, its likely classification.
510(k) variant that relies on FDA guidance, special controls, or recognized consensus standards.
Where this term appears across MedTech Terms.
Latest in MedTech
Sources
3 sourcesSources support the definition or relevant regulatory context, not necessarily every claim on this page. Each is graded against our source-tier hierarchy so you can see what rests on binding law versus commentary.
- 1MDR Article 11Tier 1 VerifiedEUR-Lexeur-lex.europa.eu
- 2IMDRF DocumentsTier 2 VerifiedIMDRFimdrf.org
- 3RAPS Regulatory FocusTier 4 VerifiedRAPSraps.org
Inline markers like [1] jump to the matching reference above.