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EC REP & Economic Operators
EC REP authorised representative and economic operators: non-EU manufacturer obligations, importers, distributors, EUDAMED and MDR traceability.
9 articles
Looking for hands-on support rather than reference material?
Discover our EU authorised representative (EC REP) service for medical devices →Choosing and contracting an authorised representative
How to choose your authorised representative: the criteria that non-EU manufacturers overlook
Beyond the annual fee, an EU authorised representative is judged on its ability to actually perform the tasks set by the MDR: keeping the required documents, cooperating with authorities, relaying sensitive requests, framing vigilance and maintaining a regulatory organisation separate from the manufacturer's.
11 min readWhat an authorised representative really costs: price ranges, models and what to avoid
There is no official price list in Europe: some offers start at around €1,600 for the first year, others run to several thousand euros. The gap has less to do with the headline price than with what the mandate actually covers.
12 min readTerminating an EC REP Mandate: Procedure, Timelines and Risks for the Manufacturer
The MDR sets no general notice period of 30, 60 or 90 days: the timetable is primarily contractual. What Article 12 does require is an agreement between the manufacturer, the incoming representative and, where practicable, the outgoing one, covering the dates, the transfer of documents and the handling of late complaints.
11 min readUnderstanding the obligations
EC REP under MDR: obligations, responsibilities, and what the authorised representative can and cannot do
The authorised representative verifies, retains, checks and cooperates — it does not become the manufacturer in the manufacturer's place. Its joint liability is neither general nor automatic: it concerns defective devices, under the precise conditions of Article 11.
12 min readPRRC and EC REP authorised representative: why combining the two roles is problematic according to MDCG 2019-07
The MDR does not explicitly prohibit one company from performing both functions. But MDCG 2019-07 Rev.1 rules out the non-EU manufacturer's PRRC and its authorised representative's PRRC being the same person and, for micro and small enterprises, belonging to the same external organisation: the authorised representative must provide an additional level of control.
9 min readRegistering in EUDAMED
Organising the importer–distributor chain
The MDR Chain of Economic Operators: Who Is Responsible for What
Manufacturer, authorised representative, importer, distributor… Regulation (EU) 2017/745 shares responsibilities among several actors in order to secure the placing of medical devices on the market. Understanding each role is essential to avoid compliance mistakes.
9 min readThe MDR Importer: regulatory obligations, responsibilities, traceability
Article 13 makes the importer a genuine regulatory checkpoint at the entrance to the European market, not a logistics provider: checks before placing on the market, identification on the packaging, traceability over ten to fifteen years, and reclassification as manufacturer if it sells under its own brand.
12 min readMDR 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 at least 10 years, 15 for implantables, and co-branding shifts the distributor into manufacturer status.
8 min readReady to secure your regulatory compliance?
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