Two roles in Regulation (EU) 2017/745 (MDR) are often confused, and the confusion costs non-EU manufacturers time. The EU Authorised Representative is a company in the EU that a manufacturer outside the EU must appoint before its devices can be placed on the EU market. The person responsible for regulatory compliance (PRRC) is an individual every manufacturer must have, inside or outside the EU. Regulation (EU) 2017/746 (IVDR) mirrors both. With EUDAMED registration now mandatory, both roles have a concrete check to make before 27 November 2026.
The Authorised Representative
A device made by a manufacturer not established in a Member State may only be placed on the EU market if that manufacturer designates a sole authorised representative (MDR Article 11(1)). The mandate must require, and the manufacturer must enable, at least these tasks:
- verify that the EU declaration of conformity and the technical documentation exist and, where applicable, that the right conformity assessment procedure was carried out;
- keep the technical documentation, the declaration and any certificate available to competent authorities;
- comply with its own EUDAMED registration and verify that the manufacturer has registered itself and its devices;
- answer competent authorities with the documentation needed to show conformity, in the language the Member State requires;
- pass on authority requests for samples or access to a device, and check they are met;
- cooperate on preventive and corrective action;
- inform the manufacturer at once of complaints and reports of suspected incidents;
- terminate the mandate if the manufacturer acts against its obligations.
The last point is the one most mandates gloss over. And the role carries real exposure: where a non-EU manufacturer has not complied with its obligations, the authorised representative is legally liable for defective devices jointly and severally with the manufacturer (Article 11(5)). An authorised representative that treats the mandate as a mailbox is taking that risk without managing it.
The PRRC
Every manufacturer must have at least one PRRC with the expertise the MDR defines (Article 15(1)). Micro and small enterprises do not have to employ that person but must have one permanently and continuously at their disposal (Article 15(2)), which is where an outsourced PRRC fits. Authorised representatives must also have at least one PRRC permanently and continuously at their disposal (Article 15(6)).
The PRRC answers for five things: that conformity is checked under the quality management system before a device is released; that the technical documentation and declaration of conformity are drawn up and kept current; that post-market surveillance obligations are met; that vigilance reporting is done; and, for investigational devices, that the required statement is issued (Article 15(3)).
What EUDAMED changes for both roles
Since 28 May 2026, actor registration, device registration and certificate registration in EUDAMED are mandatory. For devices that were already on the market before that date and are still being sold, manufacturers have until 27 November 2026 to register them.
For the authorised representative, this turns the verification task of Article 11(3)(c) into something an authority can check in seconds, because the database is public. If the manufacturer or a device is not registered, the authorised representative should not act for that device until it is. Document each check: date, SRN, Basic UDI-DI.
For the PRRC, the registration data has to match the technical documentation and the label, and keeping it current is part of keeping the documentation current. A device whose EUDAMED record contradicts its declaration of conformity is a finding waiting to happen.
What it means for your product
If you are a manufacturer outside the EU, read your authorised representative mandate against the task list above and ask how your registration was verified. If you are a small manufacturer in the EU, check that your PRRC is named, qualified, and actually available, not a name on an organisation chart. Both questions should be settled before 27 November.
We act as outsourced PRRC and, together with that role, as European Authorised Representative, including EUDAMED registration management: PRRC and European Authorised Representative.
Related briefing: What is EUDAMED? Modules, actor registration and the 27 November 2026 deadline