Authorised Representative (CE)

Roles and responsibilities of authorised representatives

An authorised representative means 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, to act on the manufacturer’s behalf in relation to specified tasks about the latter’s obligations under the Regulations.

At a minimum, authorised representatives’ obligations include verifying the following:

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.
Keep copies available of all documents and make them accessible to authorities on request. This includes technical documentation, declarations of conformity, and certificates, including their amendments and supplements.
Verify that the manufacturer has registered the requested information in EUDAMED.
Cooperate with authorities on preventive and corrective actions and inform the manufacturer immediately about complaints and authorities’ requests for samples of devices.
Be liable for defective devices together with the manufacturer.
Have permanent and continuous access to a person responsible for regulatory compliance. A change of authorised representative requires a proper agreement that defines the arrangements between the manufacturer and both the outgoing and the new authorised representatives.

**Person Responsible for Regulatory Compliance (PRRC)**

All manufacturers and EU authorised representatives must have a PRRC. Manufacturers are required to confirm that their EU authorised representative has appointed a person meeting the PRRC qualifications as outlined in Article 15 of the MDR and IVDR. If a company consists of more than one legal manufacturer, each legal manufacturer must appoint its PRRC.
MDR and IVDR introduce the new role of the person responsible for regulatory compliance, the PRRC.
Manufacturers and authorised representatives are required to appoint a PRRC
PRRCs must demonstrate adequate qualifications for this role.
Where the organisation is a micro or small business it is possible to outsource the PRRC role to an outside expert.

**Who can be a PRRC?**

Article 15(1) of the MDR and the IVDR calls for a person possessing the requisite expertise in the field of medical devices, which is defined as qualifications that are demonstrated by either:
(a) a diploma, certificate or other evidence of formal qualification, awarded on completion of a university degree or of a course of study recognised as equivalent by the Member State concerned, in law, medicine, pharmacy, engineering or another relevant scientific discipline, and at least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices.
*or:*
*(b) four years of professional experience in regulatory affairs or in quality management systems relating to medical devices.*
While formal qualification is easily documented with a diploma or certificate, professional experience in medical device regulatory affairs or in quality management systems (referring to experience gained in the EU) must be demonstrated as well. Qualification based on professional experience must be substantiated with documents such as a work contract, organisation chart, training evidence or internal records such as document releases.

Roles and responsibilities of importers

The Regulations also describe the roles and responsibilities of importers. An importer is defined as any natural or legal person established in the EU that places a device from a third country on the EU market.

The importer is responsible for:

Makang sure that the devices they place on the market bear the CE marking, are accompanied by the required information, and labelled in accordance with the Regulation and have been assigned a UDI where applicable.
Verifying that devices are registered in EUDAMED. If an importer considers that a device is not compliant with the Regulations, the device shall not be placed on the market and the importer shall inform the manufacturer and the authorised representative.
Inform the authorities if they suspect that a device has been falsified or that there is a serious risk to health. Importers should make sure that storage and transport conditions, when under their responsibility, do not jeopardise compliance.
·Importers shall indicate on the device or its packaging, or in a document accompanying the device, their name, registered trade name or registered trademark, their registered place of business and the address at which they can be contacted.
·Inform manufacturers and their authorised representatives in the event of complaints.
Keep a register of complaints, non-conforming devices, recalls and withdrawals, and escalate non-compliance to authorities if they suspect that a device has been falsified or that there is a serious risk to health.
Cooperate with authorities and provide samples or grant access to the devices