EU MDR · Article 15 · PRRC
The PRRC: who, what, and why it’s personal.
EU MDR Article 15 ended the era of dispersed, vague accountability. One qualified person now carries ultimate responsibility for conformity, safety and vigilance. Here is the role, the qualifications, and the liability.
European Champion
Platinum Award 2026
Eclevar MedTech & Milo Health · xShare × EUCROF Open Call
Led by authority
Guided by former Notified Body reviewers.
The PRRC role is where regulatory theory meets personal accountability. Our regulatory leads have seen it assessed from both sides.
Pierre-Marie Boutanquoi
Regulatory affairs, QMS and technical documentation under EU MDR and MEDDEV 2.7/1 Rev 4.
in LinkedIn
Dr Mark DaCosta
Former lead Notified Body reviewer at TÜV SÜD; QMS, conformity and vigilance across 400+ devices.
in LinkedInAwards, funding, accountability
Europe’s best-rated medical device CRO.
Platinum Award 2026
Top tier at the xShare × EUCROF Open Call, awarded to Eclevar MedTech and its Milo Health platform, presented at EUCROF 2026 in Amsterdam.
The announcement →Co-funded by the European Union
Selected through the xShare Open Call for clinical research innovation, Horizon Europe.
xShare results →Independently reported
Distinction confirmed by an independent third party, the CVBF, also an awardee of the xShare × EUCROF Open Call.
CVBF coverage →The role
The regulatory gatekeeper, defined.
Under the legacy Directives, regulatory responsibilities were dispersed across quality departments with vague accountability. EU MDR Article 15 eliminated that ambiguity by introducing the Person Responsible for Regulatory Compliance (PRRC): a legally mandated role where at least one highly qualified individual bears ultimate responsibility for device conformity, safety and vigilance.
The four core responsibilities.
Under Article 15(3), the PRRC must ensure the following are continuously met within the manufacturer’s Quality Management System.
Device conformity
Ensure the conformity of the device is checked against the QMS (e.g. ISO 13485) before any batch is released to market.
Technical documentation
Verify that the Technical Documentation and the EU Declaration of Conformity are drawn up, maintained and kept up to date.
Post-market surveillance
Guarantee that PMS obligations, including PMCF activities, are fulfilled in accordance with Article 10(10).
Vigilance reporting
Ensure reporting for serious incidents, adverse events and Field Safety Corrective Actions (FSCA) is fulfilled promptly.
Who qualifies
Not anyone can be a PRRC.
Article 15(1) strictly defines the requisite expertise. An individual must demonstrate their qualifications through one of two pathways.
Pathway A
Formal education
A diploma, certificate or other evidence of formal qualification from a university degree (or an equivalent recognised course) in law, medicine, pharmacy, engineering or another relevant scientific discipline.
Plus
- At least one year of professional experience in regulatory affairs or quality management systems for medical devices
Pathway B
Professional experience
Alternatively, at least four years of professional experience in regulatory affairs or quality management systems for medical devices, where the formal qualification is not held.
Both
Manufacturers and Authorised Representatives
The requirement applies to both manufacturers and Authorised Representatives. Each must have a PRRC, so on every side of the supply chain a qualified person is answerable for compliance. Micro and small enterprises are not required to have the PRRC within their organisation but must have one permanently and continuously at their disposal.
The PRRC at a glance
One person, ultimate accountability.
Talk to a specialist
Need a qualified PRRC, or a review of your current one?
Book a free call. We assess your PRRC arrangement against Article 15, close any gap in qualification or accountability, and put the QMS evidence behind it.
Book a free callThe PRRC role carries personal liability. Make sure yours can carry it.
An expert read checks your PRRC against Article 15, confirms the qualification pathway, and makes sure the four responsibilities are evidenced in your QMS, not just named on an org chart.
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