Changing your European authorised representative is an operation that non-EU manufacturers regularly underestimate in terms of complexity and risk. A poorly managed transition can create a period with no valid authorised representative — a period during which placing the devices on the EU market is legally prohibited.
Why the transition is delicate
At all times, a non-EU manufacturer must have a designated and active EC REP in the EU. There can be no gap between the end of the outgoing EC REP’s mandate and the effective start of the incoming EC REP’s mandate. This continuity is not automatic: it must be planned.
In addition, the EC REP’s details appear on the device labels and in the EU declaration of conformity. These documents must be updated with the new EC REP’s contact details. This update takes time and often involves modifying existing packaging stocks.
The procedure in five steps
Step 1: select and contract with the new EC REP. This step must be completed before notifying termination to the current EC REP. Sign the contract with the new EC REP first.
Step 2: notify termination to the current EC REP. Comply with the notice period set out in the contract. This notice period is generally 30 to 90 days depending on the service provider.
Step 3: transfer EUDAMED access. The manufacturer’s SRN does not change, but the EC REP associated with that SRN must be updated in EUDAMED. This is carried out by the new EC REP, in coordination with the former one where necessary.
Step 4: update the labels and the declaration of conformity. The name and address of the new EC REP replace those of the former one. This update must take place within a reasonable timeframe after the new mandate takes effect.
Step 5: inform the competent authorities where necessary. Some national authorities require notification of a change of EC REP. Check the requirements of each Member State where the devices are placed on the market.
Contractual clauses to negotiate up front
The initial contract with the EC REP should provide for balanced exit clauses: a reasonable notice period, an obligation to cooperate during the transition period, transfer of EUDAMED access, and the handling of technical files retained by the EC REP. Negotiating these clauses at the time of signing is infinitely simpler than at the time of termination.