Person Responsible for Regulatory Compliance (PRRC)

Every manufacturer and every EU authorised representative must have a PRRC. If you do not have one in-house, we can provide one.

What the regulation requires

Article 15 of the EU MDR 2017/745 and IVDR 2017/746 requires every manufacturer to have at least one person responsible for regulatory compliance within its organisation. Authorised representatives must have a PRRC permanently and continuously at their disposal. Where a company has more than one legal manufacturer, each must appoint its own PRRC. Micro and small enterprises do not need to employ the PRRC, but must have one permanently and continuously at their disposal. This is where an outsourced PRRC comes in.

What the PRRC does

The PRRC is responsible for making sure that: the conformity of each device is checked before it is released; the technical documentation and the EU declaration of conformity are drawn up and kept up to date; post-market surveillance obligations are met; vigilance reporting obligations are met; and, for investigational devices, the statement required by Annex XV is issued.

Who can be a PRRC?

Article 15(1) calls for a person with the requisite expertise in the field of medical devices, demonstrated by either:

(a) a diploma, certificate or other evidence of formal qualification, awarded on completion of a university degree or a course 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.

A formal qualification is easily documented. Professional experience must be demonstrated too, with documents such as a work contract, organisation chart, training records or internal records such as document releases.

Our PRRC service

B.S. Partnership can act as your outsourced PRRC under a written agreement. You get a named, qualified person who is permanently and continuously at your disposal, with more than 28 years of regulatory experience. Please contact us to discuss your device and the appointment you need.