The EC REP market is opaque on pricing, and offers are hard to compare without a frame of reference. Here is what lies behind the price ranges, to help manufacturers make an informed choice.
Common pricing models
Annual flat fee per manufacturer, with a list of included devices. This is the most common model. The EC REP charges an annual subscription covering the representation obligations, EUDAMED registration and updates, and a defined service level. Additional devices beyond a threshold set in the contract are subject to a surcharge.
Annual flat fee per device or per reference. Better suited to manufacturers with a broad and heterogeneous range. The per-reference rate is generally degressive beyond a certain number.
Base flat fee + pay-per-use billing. The flat fee covers the routine obligations (EUDAMED, basic representation). Specific tasks — handling a vigilance incident, responding to a request from a competent authority, providing support during an inspection — are billed separately on a daily or hourly basis.
Price ranges by device class
For class I devices under self-certification, with EUDAMED and basic representation: a range between 800 and 2,000 euros per year depending on the provider and the number of references.
For class IIa to IIb devices requiring active management of relations with notified bodies and authorities: a range between 2,000 and 6,000 euros per year for a standard scope.
For class III devices or class C and D IVDs, with more intensive vigilance and coordination requirements: a range between 4,000 and 10,000 euros per year, or even more for large portfolios.
What an offer that is too low signals
An EC REP at 500 euros per year for class IIb or III devices is mathematically incompatible with the serious performance of the function. At this price, the service cannot cover the time needed to manage the authorised representative’s actual obligations: keeping EUDAMED up to date, responding to authorities, handling vigilance emergencies.
An undersized EC REP that cannot effectively carry out its functions exposes the manufacturer to regulatory non-compliance. Ultimately, responsibility remains with the manufacturer — the EC REP’s low price is not a mitigating circumstance.
What must be included in the base fee
Whatever the price range, a serious EC REP includes in its base fee: EUDAMED registration and updates, receipt and transmission of communications from competent authorities, availability in the event of a vigilance emergency (with a contractually defined response time), and retention of the mandatory documentation.
If any of these elements is missing from the fee or subject to a surcharge, the comparison with other offers must take this real additional cost into account.