Roles and responsibilities of authorised representatives, importers and distributors

Roles and responsibilities of authorised representatives

The general obligations of authorised representatives are described in article 11 of the MDR and IVDR. An authorised representative is any natural or legal person established within the European Union who has received and accepted a written mandate from a manufacturer, located outside the EU authorising them to act on the manufacturer’s behalf in relation to specified tasks with regard to the latter’s obligations under the regulations.

The regulations also describe the tasks that the manufacturers can delegate to authorised representatives and the conditions under which this can occur. This relation must be covered by a specific mandate.

Authorised representatives shall have permanently and continuously at their disposal one person responsible for regulatory compliance (article 15, section 6 of the MDR and IVDR).

The obligations of the authorised representative include at least the verification 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 by the manufacturer [article 11, section 3, letter a) of the MDR and IVDR]. Authorised representatives shall also keep available a copy of the documents, and make them accessible on request of the Authorities. These include the technical documentation, the EU declaration of conformity and any relevant certificates, including any amendments and supplements [article 11, section 3, letter b) of the MDR and IVDR].

Moreover, the authorised representative shall verify that the manufacturer has registered the required information in the EUDAMED database, cooperate with the authorities on preventive and corrective actions, and promptly inform the official manufacturer about any complaints and requests of the Authorities for device samples. The authorised representative shall also be legally liable for defective devices – together with the manufacturer, if the latter has not complied with the obligations laid down in the regulations and is not established in the European Union (article 11, section 5 of the MDR and IVDR).

On the other hand, the provisions regarding the device design, quality system management, and drafting of technical documents are exclusive responsibility of the manufacturer.

Roles and responsibilities of importers

An importer is any natural or legal person established within the Union that places a device from a third country on the EU market.

Article 13 of the MDR and IVDR describes many of the general obligation of importers. Importers shall verify that the devices are registered in the EUDAMED database.

They are responsible of ensuring that the devices they place on the market have been CE marked, include the required information and are labelled in compliance with the regulation, and that a UDI has been assigned, where applicable.

Importers shall ensure that when a device is under their responsibility, its storage or transport conditions do not jeopardise its compliance. They shall indicate on the device or on its packaging or in a document accompanying the device their name, registered trade name or registered trade mark, their registered place of business and the address at which they can be contacted.

It is a responsibility of importers to inform manufacturers and their authorised representatives about any complaints. They shall also keep a register of complaints, of non-conforming devices and of recalls and withdrawals, and report any non conformity to the Authorities, when they suspect that a device has been falsified or that there is a serious risk for health.

Importers are also bound to cooperate with the Authorities providing samples or granting access to the devices.

Roles and responsibilities of distributors

A distributor is any natural or legal person in the supply chain, other than the manufacturer or the importer, that makes a device available on the market, up until the point of putting into service.

Article 14 of the MDR and IVDR indicates the general obligations of distributors. Distributors shall verify that the device has been CE marked, that the EU declaration of conformity of the device has been drawn up, and also that the labels and instructions for use (annex I, section 23 of the MDR and IVDR) are provided in the official languages of the Member States where the device is available (or in the languages accepted by these Member States). Distributors shall also verify that the name of the importers is indicated on each device or in the accompanying documentation and that a UDI has been assigned to the device.

They shall ensure that, while the device is under their responsibility, storage or transport conditions are appropriate and comply with the manufacturer’s recommendations.

When a distributor considers that a device is not in conformity with the regulations, such device shall not be made available on the market. In this case, the distributor should inform the other operators. They should also inform the Authorities if they suspect that a device has been falsified or that there is a serious risk for health.

Moreover, they should keep a register of complaints, of non-conforming devices and of recalls and withdrawals. Finally, distributors are bound to cooperate with the Authorities and to make them available all the documentation and information that is at their disposal.

Written By: Michela Tonci