--- title: "EC REP, Authorized Representative (EU) | MedTech Terms" description: "Legal entity established in the EU that represents a non-EU manufacturer for MDR/IVDR purposes. Plain-English Regulatory definition for MedTech teams, with exam" lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/ec-rep#term", "name": "Authorized Representative (EU)", "alternateName": "EC REP", "description": "The Authorized Representative is mandated by a written contract, registered in EUDAMED, and shares specific liabilities with the manufacturer. 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[Home](/) 2. / 3. [Terms](/terms) 4. / 5. [Regulatory](/terms?cat=Regulatory) 6. / 7. Authorized Representative (EU) [All terms](/terms) Regulatory [Regulated Pathways](/ecosystems/regulated-pathways)[Global Markets](/ecosystems/global-markets)EC REP # Authorized Representative (EU) Legal entity established in the EU that represents a non-EU manufacturer for MDR/IVDR purposes. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed May 5, 2026 ## Definition The Authorized Representative is mandated by a written contract, registered in [EUDAMED](/terms/eudamed), and shares specific liabilities with the manufacturer. They hold technical documentation, interface with competent authorities, and handle vigilance reports. What the regulation says The Authorized Representative, as defined in EU [MDR](/terms/mdr-reporting) (Regulation (EU) 2017/745) Article 11, acts on behalf of a manufacturer not established in the European Union. They ensure compliance with the MDR and serve as a contact point for competent authorities. Their duties are further elaborated in Article 11 and Annex V of the MDR, including verifying the declaration of conformity and technical documentation. ## 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. Common pitfalls - • 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 What is the primary role of an Authorized Representative under the EU MDR? The primary role is to act as a liaison between the manufacturer not based in the EU and the European competent authorities, ensuring the manufacturer's compliance with the EU [MDR](/terms/mdr-reporting). Can any entity be an Authorized Representative? What documentation must the Authorized Representative have access to? ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Regulatory EU In Vitro Diagnostic Regulation(IVDR) Regulation (EU) 2017/746 governing in vitro diagnostic medical devices in the EU. ](/terms/ivdr)[ Regulatory EU Medical Device Regulation(MDR) Regulation (EU) 2017/745 governing medical devices in the European Union. ](/terms/mdr)[ Regulatory UK Responsible Person(UKRP) UK-based equivalent of the EU Authorized Representative required for non-UK manufacturers placing devices on the GB market. ](/terms/ukrp) ### More in Regulatory · Same category [ Regulatory 510(k) Premarket Notification(510(k)) FDA submission demonstrating a device is substantially equivalent to a legally marketed predicate. ](/terms/510k)[ Regulatory 510(k) Summary vs 510(k) Statement 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. ](/terms/510k-summary-vs-statement)[ Regulatory 513(g) Request for Information(513(g)) Formal mechanism to ask FDA whether a product is a device and, if so, its likely classification. ](/terms/513g)[ Regulatory Abbreviated 510(k) 510(k) variant that relies on FDA guidance, special controls, or recognized consensus standards. ](/terms/abbreviated-510k) Cited by Where this term appears across MedTech Terms. Ecosystems (2) - [Regulated Pathways](/ecosystems/regulated-pathways) - [Global Markets](/ecosystems/global-markets) ## Primary references 3 sources Link health: 3 verified · last checked 2026-06-20 EUR-Lex· 1 IMDRF· 1 RAPS· 1 1. [1 MDR Article 11 Verified EUR-Lex · eur-lex.europa.eu ](https://eur-lex.europa.eu/eli/reg/2017/745/oj) 2. [2 IMDRF Documents Verified IMDRF · imdrf.org ](https://www.imdrf.org/documents) 3. [3 RAPS Regulatory Focus Verified RAPS · raps.org ](https://www.raps.org/news-and-articles/news-articles) Inline markers like \[1\] jump to the matching reference above. Sponsor note ### Navigating an FDA or EU MDR submission? Blue Goat Cyber supports the cybersecurity content of premarket submissions, from threat models to the 524B narrative. [Book a 30-minute discovery session](https://go.bluegoatcyber.com/meetings/blue-goat-cyber/discovery-session) - No obligation - Expert-led from minute one - NDA available on request MedTech Terms is a community resource sponsored by [Blue Goat Cyber](https://bluegoatcyber.com). Definitions are independent of any vendor. On this term Category Regulatory Acronym EC REP Sources 3 Updated 5/5/2026 [Compare with another term](/compare?a=ec-rep) Learn in 60 seconds Card Lesson Quiz Legal entity established in the EU that represents a non-EU manufacturer for MDR/IVDR purposes. - · Choosing a competent EC REP with strong notified-body and competent-authority relationships is a strategic - not just administrative - decision. - · They hold technical documentation, interface with competent authorities, and handle vigilance reports. Remember this Watch out: Misunderstanding the Authorized Representative as a mere postal address, rather than a key regulatory actor with legally defined responsibilities. Related terms - [EU Medical Device Regulation(MDR) ](/terms/mdr) - [EU In Vitro Diagnostic Regulation(IVDR) ](/terms/ivdr) - [UK Responsible Person(UKRP) ](/terms/ukrp) You may also need Auto-suggested from Regulatory and shared keywords. - [Person Responsible for Regulatory Compliance(PRRC) ](/terms/prrc) - [Common Specifications (IVDR)(CS) ](/terms/ivdr-common-specifications) - [EUDAMED ](/terms/eudamed) - [In-House IVDs (Article 5(5)) ](/terms/ivdr-in-house-devices) - [IVDR Conformity Assessment Routes ](/terms/ivdr-conformity-assessment-routes) - [Performance Study Application (IVDR) ](/terms/ivdr-performance-study-application) [All Regulatory terms](/terms?cat=Regulatory) From the Blue Goat network Related resources and services on this topic. - [ MedTech Cybersecurity Standards Authoritative reference for the standards and guidances behind medical device cybersecurity. ](https://medtechcyberstandards.com) - [ MedTech Cybersecurity Crosswalk International crosswalk of medical device cybersecurity requirements across regulators. ](https://mdccrosswalk.com) - [ MedTech Truths Common misconceptions about medical device development - debunked. ](https://mdcmisconceptions.com) - [ MedTech Launchpad MedTech funding rounds, accelerators, and launch resources. ](https://medtechlaunchguide.com) MedTech Terms An authoritative, plain-language reference for the regulatory, quality, cybersecurity, and software terms that shape modern medical devices. 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