EC REP responsibilities

A European Authorized Representative is defined as being any natural or legal person within the European Union who has accepted a written mandate from a non-EU manufacturer to act on their behalf in relation to specified tasks under MDR or IVDR. Specifically, Authorized Representatives play a pivotal role in ensuring the compliance of the devices and in serving as point of contact for the European authorities and Notified Bodies.

MDR and IVDR describe the tasks that can be delegated by the manufacturer to the authorized representative, and the conditions under which this can take place. This relationship should be covered by a precise mandate agreed between the EC REP and the manufacturer. The Authorized Representative shall perform the tasks specified in the mandate. A copy of the mandate shall be provided by the Authorized Representative to the competent authority, upon request.

The Authorized Representative is liable for defective medical devices together with the manufacturer, as well as any manufacturer's incompliance or noncompliance.

Authorized Representative's mandatory tasks under MDR and IVDR

MDR and IVDR clearly outline the core of the role of the Authorized Representative and his obligations, which shall be referenced in the mandate. The EU REP mandate shall require, and the manufacturer shall enable, the Authorized Representative to perform at least the following tasks in relation to the devices that it covers:

• make sure that the EU declaration of conformity and technical documentation are available and kept up to date;
• verify that an appropriate conformity assessment procedure has been carried out;
• keep a copy of the technical documentation, the EU declaration of conformity and, if applicable, a copy of the relevant certificate;
• comply with the registration obligations set forth in the Medical Device Regulation or In Vitro Diagnostic Medical Device Regulation;
• upon request, provide the competent authority with all the information and documentation necessary to demonstrate the conformity of a device;
• forward to the manufacturer any request by a competent authority for samples, or access to a device and verify that the competent authority receives the samples or is given access to the device;
• cooperate with the competent authorities on any preventive or corrective actions;
• immediately inform the manufacturer about complaints and reports from healthcare professionals, patients and users about suspected incidents.

What EC REP may not do

MDR and IVDR also describe activities that cannot be delegated to an authorized representative, and that may not be part of the mandate between a manufacturer and an Authorized Representative. Examples include requirements related to the design of a device, the quality management system, or the drafting of technical documentation; these are the exclusive responsibilities of the manufacturer.

Qualifications of Authorized Representatives

As per the minimum qualifications, the Authorized Representatives shall have permanent and continuous access to at least one Person Responsible for Regulatory Compliance (also known as PRRC) who has sufficient expertise regarding the European regulatory requirements for medical devices or in vitro devices. The requisite expertise shall be demonstrated by either of the following qualifications:

A) a diploma, certificate or other evidence of formal qualification, awarded on completion of a university degree or of a course of study recognized 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;

B) Alternatively, four years of professional experience in regulatory affairs or in quality management systems relating to medical devices.

How to change an EU Authorized Representative

You may switch your EC REP without invalidating your product approvals in the European Union. However, the change of Authorized Representative requires a proper agreement that defines the arrangements between the manufacturer and both the outgoing and the new EC REP.

Besides, keep in mind that because your EC REP information must be printed on your labeling, switching your European Authorized Representative may incur additional costs as you will need to change labeling and deal with the issue of products that are already on the market.