EU IVDR Person Responsible for Regulatory Compliance under Article 15

1. Key takeaways

The manufacturer’s organisation must have at least 1 person responsible for regulatory compliance (PRRC), qualified through one of two routes. Route (a) requires a diploma, degree or formal qualification evidence 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 IVDs. Route (b) requires 4 years of comparable professional experience. Micro and small enterprises, as defined in Commission Recommendation 2003/361/EC, are not required to have the person within their organisation, but must have that person permanently and continuously at their disposal (Article 15(2)).

The PRRC is a functional position with five statutory duties, not a title on an organisation chart. Authorised representatives must also have their own qualified PRRC permanently and continuously at their disposal, and where several persons share the role, their responsibilities must be defined in writing.

2. Legal basis

The table below lists the provisions governing the PRRC and the definition of micro and small enterprises.

The enterprise-size definition matters because the Article 15(2) exception is available only to micro and small enterprises as measured by Recommendation 2003/361/EC; group membership and headcount thresholds should be checked before relying on it.

3. Expert insights

Insight 1: the PRRC is a position, not a name-plate.

Article 15(3) lists five minimum duties: (a) verifying, before release, the conformity of devices in accordance with the QMS; (b) ensuring that the technical documentation and the EU declaration of conformity are drawn up and kept up to date; (c) ensuring compliance with the post-market surveillance obligations under Article 10(9); (d) ensuring compliance with the reporting obligations under Articles 82 to 86; and (e) issuing the statement required by Annex XIV Section 4.1 for interventional clinical performance studies or other performance studies exposing subjects to risk. Every one of these duties requires traceable signatures and records; a PRRC whose name appears in the QMS but whose signature appears nowhere in release, documentation or vigilance records will not survive a notified body audit or a competent authority inspection.

Insight 2: the micro and small enterprise exception is about availability, not absence of need.

Article 15(2) allows micro and small enterprises to operate without a PRRC inside the organisation, but the person must be permanently and continuously at their disposal. Outsourcing to an external consultant is permissible, but only with an arrangement and evidence demonstrating that the consultant is available at any time, and the consultant must personally satisfy the qualification requirements of Article 15(1). A consultancy contract with business-hours response times, or a pool of interchangeable consultants whose qualifications are not documented, does not meet the standard and should be renegotiated before an inspection finds it.

Insight 3: authorised representatives need their own PRRC.

Article 15(6) requires authorised representatives to have permanently and continuously at their disposal at least one person with the requisite expertise in EU IVD regulatory matters, qualified under the same routes as Article 15(1). When evaluating an authorised representative organisation, request evidence of that person’s degrees and experience rather than relying on the registered address or the marketing brochure. A representative without a demonstrably qualified PRRC is a structural weakness in the manufacturer’s own compliance chain, since Article 11 duties and Article 15(6) staffing tend to fail together.

Insight 4: Articles 15(4) and 15(5) are two safeguards for internal governance.

Where several persons share the responsibility, their respective areas of responsibility must be defined in writing (Article 15(4)). The PRRC must not be disadvantaged within the organisation for performing the role, regardless of whether they are an employee (Article 15(5)). Both safeguards are frequently missing written evidence in group structures and outsourced arrangements: shared roles operate on informal understandings, and protection against disadvantage exists only in culture rather than in policy. Documenting both is cheap now and expensive to retrofit under audit pressure.

4. Practical recommendations

1. Build a qualification file for each PRRC: degree evidence, professional history and continuing education records, annotated with the applicable route under Article 15(1).
2. Where a micro or small enterprise outsources the role, conclude a service agreement that states permanent and continuous availability explicitly, with response time limits.
3. Establish signature points and record templates for the five duties of Article 15(3), especially (a) verification before release and (c) PMS compliance.
4. Where responsibility is shared, issue a written definition of each person’s area of responsibility (Article 15(4)).
5. When selecting an authorised representative, make the presence of an in-house qualified PRRC a mandatory due diligence item.

5. Verification checklist

• □ At least 1 PRRC designated, with evidence of qualification route (a) or (b) archived
• □ Route (a) confirmed as degree plus 1 year of experience; route (b) confirmed as 4 years of experience
• □ Where no in-house PRRC applies to a micro or small enterprise, a written arrangement of permanent and continuous availability in place (Article 15(2))
• □ The 5 duties of Article 15(3) implemented as signature points and records
• □ Shared responsibility defined in writing (Article 15(4))
• □ The authorised representative has a qualified PRRC in place under Article 15(6)

Regulatory information verified as of 29 October 2026.

GRZAN helps manufacturers designate and support a compliant PRRC under Article 15, drafts the written arrangements required for shared and outsourced roles, and audits authorised representatives for Article 15(6) readiness across the EU IVDR market. For tailored compliance support, contact info@grzanglobal.com.