On 31 October 2022, new guidance for the EU Authorised Representative and the Person Responsible for Regulatory Compliance (PRRC) was published. This document is intended for manufacturers, EU Authorised Representatives, importers and distributors of medical devices. It describes in clear language how these parties can work together within the context of the Medical Device Regulation (MDR 2017/745).

EU Authorised Representative

Medical device manufacturers from outside the EU are obliged to appoint an EU Authorised Representative. An EU Authorised Representative acts on behalf of the manufacturer and has the following duties, among others:

• checking the CE marking on the product
• drawing up the EC/EU Declaration of Conformity
• keeping the Declaration and Technical Documentation permanently available
• acting as a contact person for oversight authorities

The new guideline provides, among other things, regulations for the authorised representative’s mandate. This way, a manufacturer and their authorised representative may give form to their agreements and collaboration themselves, as long as there is a written mandate that meets the minimum requirements of Article 11 paragraph 3 of the MDR, the content of which has been agreed between the parties.

The guidance also provides more information about the above-mentioned duties and the minimum responsibilities that the authorised representative must assume pursuant to Article 11 paragraph 3 of the MDR. The manufacturer must enable the authorised representative to actually execute them. For example, the guidance describes how to interpret the term ‘keep permanently available’: the manufacturer must provide the EU Authorised Representative with the required documentation, in the most recent version (i.e. including the latest changes and/or additions). This may be in paper or electronic form.

Lastly, the guidance provides a further explanation of the concept of ‘joint liability’ of the manufacturer and the authorised representative, as used in Article 11 of the MDR.

PRRC

Article 15 of the MDR requires each medical device manufacturer to employ its own PRRC, with the exception of micro and small enterprises (enterprises with a turnover of less than 10 million euros or fewer than 50 employees). They may also hire an external PRRC. This PRRC must then be permanently and continuously available to the manufacturer.

The PRRC monitors compliance with the MDR within the organisation. A PRRC must therefore have knowledge of and experience with the regulations in the context of medical devices and the implementation and management of a medical quality management system.

The duties of a PRRC include:

• checking the conformity of the devices, in accordance with the quality management system
• supervising the preparation and periodic checking of the Technical Documentation
• supervising compliance with post-market surveillance obligations
• supervising obligations related to reporting incidents

For an explanation of this, the guidance references MDCG 2019-71, the guideline that provides an explanation of the PRRC.

Need some help?

Are you a micro or small enterprise? Then Certification Company can fulfil the role of PRRC for your organisation. This means that you bring our expertise in-house so you can concentrate on your core tasks. Certification Company’s PRRCs meet all the requirements of the MDR.
Certification Company can also act as your EU Authorised Representative.

Do you have any questions about this? Then please contact our experts. We will be happy to help you!