The Person Responsible for Regulatory Compliance under MDR Article 15

1. Key takeaways

Article 15 of the MDR requires every manufacturer to have at least one person responsible for regulatory compliance (PRRC) within its organisation; authorised representatives must likewise possess at least one PRRC permanently and continuously at their disposition. The qualification threshold follows one of two paths: a diploma in law, medicine, pharmacy, engineering or another relevant scientific discipline plus at least 1 year of professional experience in regulatory affairs or in quality management systems relating to medical devices; or 4 years of such professional experience. The PRRC is a person-level requirement that the Regulation attaches to the organisation, and its duties reach into the quality management system, the technical documentation and the vigilance process, making the appointment one of the structural decisions of an MDR compliance programme rather than a personnel detail.

2. Legal basis

3. Expert insights

Insight 1: The PRRC is a new person-level requirement of the MDR with no counterpart in ISO 13485 systems.

Neither the previous directives nor ISO 13485 contain a mandatory regulatory compliance officer role. Article 15(1) of the MDR writes the requirement into the Regulation and requires the duties to be recorded in the quality management system documentation. Small and medium-sized enterprises may locate the PRRC outside the organisation, provided the person is permanently and continuously at their disposition, but they cannot do without one. For many ISO 13485-certified manufacturers, this article is the first gap identified when converting to the MDR: the certification alone does not satisfy Article 15, and the role, its duties and its authority must be established, documented and evidenced before the notified body or the authority asks.

Insight 2: The conversion between the two qualification paths deserves attention.

Path one: a diploma in a relevant discipline plus at least 1 year of professional experience. Path two: no diploma required, but 4 years of professional experience. On both paths, the professional experience must be in regulatory affairs or in quality management systems relating to medical devices; experience from other industries in quality or regulatory roles does not count. When screening candidates or external providers, companies should therefore verify the domain of the experience, not only its length, and keep evidence of both the diploma and the period of relevant work in the qualification file, since the burden of demonstrating eligibility rests with the appointing organisation.

Insight 3: The PRRC of the authorised representative is a separate requirement and cannot be replaced by the PRRC of the manufacturer.

Under Article 15(6), the authorised representative must permanently and continuously have at least one PRRC meeting the qualification requirements at its disposition. This runs in parallel with the obligation of the manufacturer itself under Article 15(1). When selecting an authorised representative, a company should therefore ask the provider to identify its PRRC by name, background and substitution arrangement. The two roles interact operationally, since the representative handles registration and vigilance communication for non-EU manufacturers, but each entity satisfies Article 15 on its own account, and neither appointment discharges the other.

Insight 4: The duties of the PRRC extend into the post-market phase.

The duties of the PRRC include ensuring that the technical documentation and the EU declaration of conformity are drawn up and kept up to date, ensuring that the post-market surveillance and vigilance obligations are fulfilled, and ensuring that the reporting duties under Article 87 are met. This makes the PRRC not a filing clerk but the first responsible person for post-market compliance, and it is a mandatory checkpoint during on-site inspections by competent authorities. Companies should give the role real access to quality data and incident information, since a PRRC who learns of complaints late cannot perform the duties the article assigns. In practice, the post-market surveillance process should name the PRRC in its escalation path, so that vigilance decisions carry the accountability the Regulation expects.

4. Practical recommendations

1. Build a qualification file for each PRRC: diploma certificates, curriculum vitae, evidence of years of relevant professional experience, the appointment document and the substitution arrangement.
2. Where a small or medium-sized enterprise uses an external PRRC, the contract must state that the person is permanently and continuously at its disposition, with agreed response times.
3. Write the duties and authorities of the PRRC into the quality management system documents, avoiding unclear overlap with the quality manager role.
4. When selecting an authorised representative, add the questions of who the PRRC is and who substitutes to the due diligence checklist.
5. Establish a notification and handover process for PRRC changes, and update the contact details in EUDAMED in the same step.

5. Verification checklist

• □ The manufacturer has at least one qualified PRRC in place (Article 15(1))
• □ The PRRC qualification file contains diploma and experience evidence (the 1-year or 4-year path)
• □ The authorised representative has confirmed in writing that its PRRC is permanently and continuously at its disposition (Article 15(6))
• □ The duties of the PRRC are written into the quality management system documents
• □ A substitute PRRC has been designated
• □ A change process for the PRRC is in place and linked to EUDAMED updates

Regulatory information verified as of 29 October 2026.

About GRZAN. GRZAN helps manufacturers establish and maintain the PRRC function required by Article 15 of Regulation (EU) 2017/745. We assess qualifications against the two statutory paths, document the role within your quality management system, and coordinate PRRC arrangements with your authorised representative so that both sides of Article 15 are covered on your route to CE marking in the European Union. For PRRC support and full MDR compliance services in the EU market, contact info@grzanglobal.com.