The Article 11 operating duties

The authorised representative’s tasks are defined in the written mandate and Article 11 of the MDR or IVDR. They include checking that the declaration of conformity and technical documentation have been drawn up and that an appropriate conformity-assessment procedure has been completed.

The representative must also keep specified documentation available, support registration duties, respond to competent-authority requests, facilitate access to samples or devices, cooperate on preventive or corrective action, and forward complaints and suspected-incident reports to the manufacturer.

What changes must reach the representative

• changes to the legal manufacturer, sites, authorised signatories or ownership;
• new or discontinued devices and variants;
• changes to intended purpose, classification, labels, instructions or certificates;
• significant quality, clinical, performance or cybersecurity findings;
• complaint trends, serious incidents, field actions and authority correspondence;
• changes to importers, distributors or target Member States that affect controlled records.

A workable mandate needs service levels

The contract should identify contacts, response times, escalation rules, controlled document channels and decision rights. MEDDEV also needs current access to the agreed file and the people able to answer technical, quality and vigilance questions. Without that operating model, even a well-drafted mandate can fail during an authority request.

Why annual review matters

A periodic portfolio and evidence review checks whether the mandate, certificates, labels, registrations and current commercial scope still match. It does not replace event-driven communication. Serious incidents, field actions and material changes must follow the applicable process when they occur.