The market for authorised representatives exploded with the MDR. Offers at 500 euros per year sit alongside specialised providers charging several thousand euros annually. A manufacturer who chooses its EC REP on price alone makes a strategic mistake whose consequences it will only measure when something goes wrong.
Criterion 1: the genuine ability to perform the function
An EC REP must be able to carry out its obligations effectively, not theoretically. This means: a physical address in the EU (not merely a postal registration), a team able to respond to competent authorities within the MDR deadlines (2 days for a serious threat to public health), a documented procedure for handling vigilance emergencies, and guaranteed access to the manufacturer’s technical documentation.
The question to ask during selection, without beating around the bush: “What do you do if the ANSM contacts you about a serious incident on a Friday at 5pm?” The answer reveals in thirty seconds whether the provider has genuinely thought about the function it is offering or whether it is selling a line on a label.
Criterion 2: sector experience suited to your device’s class
An EC REP that exclusively manages self-certified class I devices does not have the same regulatory exposure as an EC REP that manages class IIb devices or class D IVDs under IVDR. Vigilance situations, relations with notified bodies, inspection requests from competent authorities: all of this is substantially different depending on the class.
Check the profile of the EC REP’s client portfolio and ask for references in your type of device.
Criterion 3: contractual robustness
The EC REP contract commits the manufacturer for several years. Three clauses deserve particular attention.
The terms of access to the technical documentation: how can the EC REP obtain the documentation in an emergency? Who is the manufacturer’s point of contact? What is the guaranteed transmission deadline?
The procedures in the event of a vigilance incident: who does what, in what order, with what deadlines? This procedure must be written into the contract, not implied.
The termination and transition conditions: notice periods, the fate of EUDAMED registrations, reciprocal obligations during the transition period to a new EC REP.
Criterion 4: no confusion with the PRRC
The MDCG 2019-07 Rev.1 guidance (December 2023) specifies that a single entity cannot be both EC REP and PRRC for the same manufacturer. This combination creates a conflict of interest incompatible with the independent performance of the two roles.
A provider that offers both functions in the same contract without clearly distinguishing them is either poorly informed about this guidance or deliberately ignoring a regulatory position that is the subject of a European consensus. In either case, this is not a good sign.
Criterion 5: measurable responsiveness
Before signing, test responsiveness concretely: send an email with a technical question at 6pm on a Thursday. The speed and quality of the response are reliable indicators of what the day-to-day operational relationship will be.
An EC REP that takes 72 hours to respond to a commercial enquiry will not be able to handle a vigilance emergency within the 2 days imposed by the MDR.
Regulatory source: MDCG 2019-07 Rev.1 — health.ec.europa.eu