Resources
EC REP & Economic Operators
EC REP authorised representative and economic operators: non-EU manufacturer obligations, importers, distributors, EUDAMED and MDR traceability.
9 articles
Terminating an EC REP Mandate: Procedure, Timelines and Risks for the Manufacturer
Any gap without a valid authorised representative makes marketing in the EU illegal: contract the new EC REP before notifying termination to the outgoing one, whose notice period runs from thirty to ninety days.
PRRC and EC REP authorised representative: why combining the two roles is problematic according to MDCG 2019-07
Placing the authorised representative and the person responsible for regulatory compliance with a single provider creates a structural conflict of interest. MDCG 2019-07 Rev.1, issued in December 2023, rules out this combination for the same manufacturer.
The MDR Chain of Economic Operators: Who Is Responsible for What
Manufacturer, authorised representative, importer, distributor: each answers for distinct obligations set precisely by Regulation (EU) 2017/745. A distributor that resells a device under its own brand shifts to manufacturer status and takes on those duties.
The MDR Importer: regulatory obligations, responsibilities, traceability
Article 13 of the MDR requires the importer to check CE marking, the EC REP mandate and EUDAMED registration before any placing on the market, then to keep batch traceability for at least 5 years, 10 years for implantable devices.
EUDAMED Registration for Non-EU Manufacturers: the Role of the EC REP
The ACTOR module requires an address in the Union, forcing any foreign manufacturer to go through its authorised representative to obtain the SRN. That identifier remains permanent, even when the EC REP is replaced.
EC REP under MDR: obligations, responsibilities, and what the authorised representative can and cannot do
Article 11(3) makes the authorised representative jointly liable with the non-EU manufacturer: EUDAMED registration, vigilance, retention of the technical file for five to ten years. Reducing this role to a box on the label exposes both parties.
MDR Distributor: New Obligations, Verifications and Traceability
Checking the CE marking, the language of the instructions and UDI registration conditions any making available. Traceability runs for 5 years, 10 for implantables, and co-branding shifts the distributor into manufacturer status.
What an authorised representative really costs: price ranges, models and what to avoid
Depending on the device class, an EC REP charges between 800 and 10,000 euros a year. Below that, an offer of 500 euros for a class IIb or III device cannot cover the real obligations of the role.
How to choose your authorised representative: the criteria that non-EU manufacturers overlook
Beyond the annual fee, an authorised representative is judged on its ability to answer the authorities within the two days of a serious threat and on its compliance with MDCG 2019-07, which bars combining the EC REP and PRRC roles.
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