PRRC
Person Responsible for Regulatory Compliance
The compliance officer required under MDR Article 15 — qualified, documented and formally designated.
The PRRC (Person Responsible for Regulatory Compliance) is the person required by Article 15 MDR to be responsible for regulatory compliance within the company. Every manufacturer must have at least one PRRC — and so must the EU authorised representative of a non-EU manufacturer.
In practice in the German hospital market
Appointing a competent PRRC is often the latest and most regularly underestimated step — a missing or belatedly designated PRRC leads to audit findings and can delay listings.
Which qualifications does the MDR require?
Article 15(1) MDR allows two routes:
- Degree plus experience: a university degree in law, medicine, pharmacy, engineering or another relevant scientific discipline — and at least one year of professional experience in regulatory affairs or quality management systems relating to medical devices.
- Experience alone: four years of professional experience in regulatory affairs or quality management systems relating to medical devices.
Manufacturers of custom-made devices can demonstrate the expertise with at least two years of relevant professional experience.
What the PRRC is responsible for
Article 15(3) MDR requires the PRRC to ensure, at a minimum, that:
- the conformity of the devices is appropriately checked under the quality management system before release;
- the technical documentation and the EU declaration of conformity are drawn up and kept up to date;
- post-market surveillance obligations are met — including PMS reports and the PSUR;
- the reporting obligations under Articles 87 to 91 MDR (vigilance) are fulfilled;
- for investigational devices, the statement required under Annex XV is issued.
The PRRC must not be disadvantaged within the organisation for the proper performance of these duties (Article 15(5)).
Special rules for SMEs and non-EU manufacturers
Micro and small enterprises within the meaning of Recommendation 2003/361/EC do not have to employ the PRRC themselves. The person must, however, be “permanently and continuously at their disposal” (Article 15(2)) — in practice through a service contract with clearly documented availability.
The same rule applies to the EU authorised representative (Article 15(6)). A manufacturer outside the EU therefore usually has two PRRC roles to settle: its own as manufacturer, and the one at the authorised representative. Both have to work closely together, because vigilance cases and requests from authorities run through the authorised representative.
How MEX supports you
We provide the PRRC role under Article 15 MDR as part of Module 2 — qualified, documented and audit-ready, connected to the authorised representative role of your German entity. If you fill the PRRC role internally, we coordinate the interfaces.
Frequently asked questions
- Can the PRRC be external?
- For micro and small enterprises, yes: they do not have to employ the PRRC themselves, but the person must be permanently and continuously at their disposal. The same applies to EU authorised representatives. Larger manufacturers need the PRRC within their organisation.
- Does a non-EU manufacturer's PRRC have to be based in the EU?
- The MDR does not require the manufacturer's PRRC to be located in the EU. The EU authorised representative, however, needs a PRRC of its own — so non-EU manufacturers usually have two PRRC roles to fill.
- Can there be more than one PRRC?
- Yes. If several people share the responsibility, their respective areas have to be stipulated in writing.