What is an EC Rep? EU Authorized Representative Explained
EC rep (European Community Representative) means the same as EU Authorized Representative or EU AR: a legal entity in the EU/EEA that non-EU medical device and IVD manufacturers must appoint before placing products on the EU market under EU MDR and IVDR. This page defines the term, explains when you need one, and links you to tools and the EU Representative provider directory.
Compare EU Authorized Representatives & Get Quotes Do I Need an EU AR? Cost CalculatorEC Rep Definition: What Does EC Rep Mean?
EC rep and EU Authorized Representative (also spelled EU Authorised Representative) mean the same thing: the natural or legal person established in the European Union or EEA who has received a written mandate from a manufacturer located outside the Union to act on the manufacturer's behalf for specified regulatory tasks. Under EU MDR 2017/745 and EU IVDR 2017/746, non-EU manufacturers of medical devices and in vitro diagnostics must designate an EU Authorized Representative before placing products on the EU market. The EC rep is responsible for ensuring the manufacturer complies with certain obligations and can be addressed by authorities in place of the manufacturer.
Terms you may see used interchangeably: EC rep, EC representative, EU rep, EU authorized representative, eu authorised representative, european authorized representative, european authorised representative, authorized representative for medical devices, authorised representative eu.
When Do You Need a European Authorized Representative?
You need an EU Authorized Representative (EC rep) if you are a manufacturer established outside the EU/EEA and you place medical devices or IVDs on the EU/EEA market. If you are established inside the EU/EEA, you do not need an Authorized Representative for EU market access. Importers and distributors do not appoint an EU AR in the same way—the obligation falls on the non-EU manufacturer. Use our Do I Need an EU Authorized Representative? tool for a quick check, then compare EU AR providers and request quotes.
EU MDR 2017/745 and EU IVDR: Authorized Representative Role
Under EU MDR Article 11 and IVDR Article 11, the EU Authorized Representative must be established in the Union and is responsible for ensuring the manufacturer’s compliance with the regulation (e.g. conformity, technical documentation, post-market obligations). The mandate must be in writing and specify the tasks. The AR can be addressed by authorities and is jointly and severally liable with the manufacturer for defective devices. European authorized representative services typically include registration in EUDAMED, keeping documentation available, and cooperating with competent authorities. For medical device authorized representative and IVD needs, compare providers in our EU Authorized Representative directory.
Useful Tools & EU Representative Provider Directory
Use these utilities and then link through to the EU Representative provider directory to compare european authorized representative services and get quotes.
Compare vetted EU AR (EC rep) providers. Request quotes for medical device and IVD mandates.
Tool Do I Need an EU Authorized Representative?Quick eligibility check: see if you need an EC rep under MDR/IVDR.
Calculator EU Authorized Representative Cost CalculatorEstimate EU AR costs and request quotes from providers.
Resource EU Authorized Representative List vs EUDAMEDOfficial source vs directory: how to compare EU AR providers.
Checklist EU AR Mandate Readiness ChecklistAre you ready to appoint? DoC, tech doc, EUDAMED, PRRC—then compare providers.
Tool MDR / IVDR Device Class FinderFind your device class (I, IIa, IIb, III or IVD A–D), then use the cost calculator.
FAQ: EC Rep Meaning & EU Authorized Representative
What does EC rep mean?
EC rep means European Community Representative, also known as EU Authorized Representative (EU AR). It is the entity in the EU/EEA that non-EU medical device and IVD manufacturers must designate under EU MDR and IVDR to place products on the EU market.
What is the definition of EC rep?
The EC rep (EU Authorized Representative) is the natural or legal person established in the Union who has a written mandate from a non-EU manufacturer to act on their behalf for specified tasks under MDR/IVDR Article 11.
Is there a list of EU Authorized Representatives?
EUDAMED is the official EU database where economic operators (including EU ARs) register. There is no simple downloadable “list.” To compare EU authorized representative service providers and get quotes, use the EU Representative provider directory.
Do I need an EC rep for medical devices?
If you are a manufacturer established outside the EU/EEA and you place medical devices or IVDs on the EU market, yes. Use our Do I Need an EU AR? tool, then compare EU AR providers.
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