Article 15 of EU MDR 2017/745 requires every manufacturer to have at least one Person Responsible for Regulatory Compliance (PRRC) within their organisation. This is not optional — and for small manufacturers it is one of the most commonly misunderstood obligations.
The Person Responsible for Regulatory Compliance (PRRC) is a mandatory role under Article 15 of EU MDR 2017/745. Every manufacturer — regardless of size or device class — must have at least one PRRC. The PRRC ensures that devices are properly certified, documented and monitored throughout their lifecycle on the EU market.
The PRRC is not the same as an EU Authorised Representative. The EU AR represents the manufacturer to Competent Authorities. The PRRC is responsible for internal compliance functions within the manufacturer's quality management system.
Ensure conformity of devices. The PRRC must ensure that the conformity of devices is appropriately checked before a device is released. This includes sign-off on technical documentation completeness for each device placed on the market.
Manage vigilance and PMS obligations. The PRRC is responsible for ensuring that post-market surveillance obligations are fulfilled — including PSUR preparation, PMCF studies and vigilance reporting under Article 87.
Oversee EUDAMED registration. The PRRC must ensure that manufacturers and devices are properly registered in EUDAMED before any device is placed on the EU market.
Declaration of Conformity. The PRRC oversees preparation of the EU Declaration of Conformity and must ensure it accurately reflects the device's compliance status at all times.
Labelling and IFU compliance. The PRRC ensures labelling meets all requirements of Annex I Chapter III of the MDR, including UDI requirements and language requirements for each member state.
Under Article 15(1) of EU MDR, the PRRC must hold a degree in law, medicine, pharmacy, engineering or a natural science, and have at least one year of professional experience in regulatory affairs or quality management systems relating to medical devices.
Under Article 15(2), four years of professional experience in regulatory affairs or quality management systems can substitute for the degree requirement. This alternative pathway is particularly relevant for experienced industry professionals without a formal degree in the listed disciplines.
Manufacturers qualifying as microenterprises under EU Recommendation 2003/361/EC — fewer than 10 employees and annual turnover or balance sheet total not exceeding €2 million — are not required to have the PRRC within their organisation. They may contract an external PRRC to fulfil Article 15 obligations.
Importantly, even manufacturers who are not microenterprises can use an external PRRC under certain conditions, as long as the external PRRC has the required qualifications and the arrangement is properly documented in the quality management system.
NordMDR AB provides external PRRC services for manufacturers who cannot fulfil Article 15 requirements internally. This is particularly valuable for small non-EU manufacturers, startups entering the EU market for the first time, and companies going through a transition period before hiring internal regulatory staff.
Our external PRRC service includes documented PRRC appointment, review of technical documentation before device release, post-market surveillance oversight, EUDAMED registration support, and vigilance reporting coordination — all on a fixed annual fee.
NordMDR AB provides qualified external PRRC services under Article 15 of EU MDR 2017/745. Fixed annual fee. Sweden-based. Covering all 27 EU member states.
Get Free Assessment →