Authorised Representative and Product Liability Insurance

European Authorized Representatives (MDR Article 11)

If the manufacturer of a device is not established in a Member State, the device may only be placed on the Union market if the manufacturer designates a single European Authorized Representative.

Such designation is considered a mandate granted to the Authorized Representative and is only valid if the Authorized Representative accepts it in writing. The mandate must cover all devices within the same group at a minimum.

The European Authorized Representative must perform the tasks specified in the mandate agreed upon with the manufacturer. The Authorized Representative must also provide a copy of the mandate to the competent authorities upon request.

The mandate must require the Authorized Representative to perform at least the following tasks concerning the devices specified in the mandate, and the manufacturer must facilitate this:

Verify that the EU declaration of conformity and technical documentation have been drawn up and, where applicable, ensure that the manufacturer has appropriately carried out the conformity assessment procedures.
Keep copies of the technical documentation, the EU declaration of conformity, and, where applicable, any amendments or supplements to certificates issued under Article 56, available for the competent authority for the period mentioned in Article 10(8).
Comply with the registration obligations laid down in Article 31 and verify that the manufacturer complies with the registration obligations under Articles 27 and 29.
Provide the competent authorities with all the information and documentation necessary to demonstrate the conformity of a device, in the Union’s official language determined by the Member State concerned, upon request.
Transmit any request from the competent authority of the Member State where the Authorized Representative is established for samples or access to a device to the manufacturer and verify that the competent authority has received the samples or been granted access to the device.
Cooperate with the competent authorities on any preventive or corrective actions taken to eliminate or mitigate the risks posed by devices.
Immediately inform the manufacturer of any complaints or reports from healthcare professionals, patients, or users about suspected incidents related to a device for which they have been designated.
Terminate the mandate if the manufacturer acts contrary to their obligations under this Regulation.
The mandate referred to in paragraph 3 does not delegate the manufacturer’s obligations under Article 10(1), (2), (3), (4), (6), (7), (9), (10), (11), and (12).

Notwithstanding paragraph 4, if the manufacturer is not established in a Member State and does not comply with the obligations laid down in Article 10, the European Authorized Representative is legally and jointly liable, separate from the manufacturer, for defective devices.

An Authorized Representative terminating the mandate under paragraph 3(h) must immediately inform the competent authority of the Member State where it is established and, where applicable, the notified body involved in the conformity assessment of the device, providing the reasons for termination.

Any reference in this Regulation to the competent authority of the Member State where the manufacturer has its registered place of business shall be understood as a reference to the competent authority of the Member State where the designated Authorized Representative has its registered place of business, as referred to in paragraph 1.

Liability Insurance (MDR Article 10(16))

Natural or legal persons can claim compensation for damages caused by defective devices in accordance with applicable Union or national law.

Manufacturers must take measures to ensure sufficient financial coverage for their potential liability under Directive 85/374/EEC (Liability for Defective Products) proportionate to the risk class and type of device and the size of the enterprise. These measures do not affect other protective measures under applicable national laws.

As part of the certification process, manufacturers may be required to submit proof of product liability insurance. However, the requirement does not explicitly mandate documentary evidence, so it is uncertain if all notified bodies will require proof of insurance. Manufacturers should monitor any additional interpretations or changes to this requirement and confirm specific documentation requirements with the notified body conducting the certification.

Please CONTACT US for any inquiry regarding European Authorised Representative and/or Product Liability Insurance.