Your EU Authorised Representative & PRRC for MDR/IVDR medical devices

The Authorised Representative mandate and liability

The mandate is the legal basis of the Authorised Representative role. Article 11 MDR/IVDR sets the minimum tasks it must include, what it cannot delegate, and when the Authorised Representative becomes liable alongside the manufacturer.

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Article 11 MDR / IVDR Sole AR per generic device group Accepted in writing Joint and several liability

Designation

A manufacturer not established in a Member State may only place a device on the Union market if it designates a sole Authorised Representative. The designation constitutes the mandate, which is valid only when accepted in writing by the Authorised Representative and is effective at least for all devices of the same generic device group.

Minimum tasks in the mandate

Verify that the EU declaration of conformity and technical documentation have been drawn up and, where applicable, that an appropriate conformity assessment procedure has been carried out
Keep a copy of the technical documentation, the declaration of conformity and any certificates available to competent authorities
Comply with the registration obligations and verify that the manufacturer has complied with its registration obligations
Provide a competent authority, on request, with the information and documentation needed to demonstrate conformity
Forward to the manufacturer any request from a competent authority for samples or access to a device
Cooperate with competent authorities on preventive or corrective action
Immediately inform the manufacturer about complaints and reports from healthcare professionals, patients and users about suspected incidents
Terminate the mandate if the manufacturer acts contrary to its obligations under the Regulation

What cannot be delegated

The mandate cannot transfer the manufacturer's core obligations to the Authorised Representative - among them the quality management system, conformity assessment, technical documentation and post-market surveillance remain with the manufacturer.

Liability

Where the manufacturer is not established in a Member State and has not complied with its obligations under Article 10, the Authorised Representative is legally liable for defective devices on the same basis as, and jointly and severally with, the manufacturer. That is why a serious Authorised Representative reviews your documentation before accepting a mandate.

An Authorised Representative that terminates its mandate because the manufacturer acts contrary to its obligations must immediately inform the competent authority of the Member State where it is established and, where applicable, the Notified Body.

Frequently asked questions

Can I have several EU Authorised Representatives?

Not for the same devices. The manufacturer must designate a sole Authorised Representative, and the mandate covers at least all devices of the same generic device group.

Is the EU Authorised Representative liable for my devices?

If you are not established in the EU and have not complied with your Article 10 obligations, the Authorised Representative is liable for defective devices jointly and severally with you.

When is the mandate valid?

Only once it has been accepted in writing by the Authorised Representative.

Check whether you need an EU Authorised Representative

Tell us your device type, class and where your company is established. We will qualify the next step before any mandate is signed.

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