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Person responsible for regulatory compliance (PRRC)

Regulatory basis

The PRRC requirement is established in MDR Article 15 and IVDR Article 15.

Disclaimer

This site provides general information only and does not constitute legal or regulatory advice. Always consult the official regulation text and, where appropriate, a qualified regulatory professional.

What is the PRRC?​

The Person Responsible for Regulatory Compliance (PRRC) is an individual who must be in place within every manufacturer and every authorised representative (EU REP) to ensure that the organisation meets its MDR/IVDR obligations.

The PRRC is a named individual — not a department, not a committee, and not a generic role title. The organisation must be able to identify the specific person(s) holding this responsibility and make this information available to competent authorities on request.

Who must have a PRRC?​

OrganisationPRRC required?
EU-based manufacturer✅ Yes
Non-EU manufacturer✅ Yes (typically fulfilled by the PRRC of the EU REP)
EU REP✅ Yes
Importer❌ No
Distributor❌ No
Micro and small enterprises (< 250 employees, ≤ €50M turnover)⚠️ May contract external PRRC — see below

Qualifications required​

The PRRC must have expertise in the field of medical devices. MDR Article 15(1) specifies the qualification pathways:

Option A — Degree + experience​

A diploma, certificate, or other evidence of formal qualification awarded on completion of a university degree or equivalent course of study in law, medicine, pharmacy, engineering, or another relevant scientific discipline, plus a minimum of one year of professional experience in regulatory affairs or QMS relating to medical devices.

Option B — Experience alone​

Four years of professional experience in regulatory affairs or QMS relating to medical devices (without the formal degree requirement).

The experience must be in regulatory affairs or quality management — general clinical, scientific, or engineering experience without regulatory application does not satisfy the requirement on its own.

note

MDR Article 15(6) states that manufacturers may designate a PRRC who does not permanently reside or work in the EU, provided the EU REP designates a PRRC who is always and immediately available. In practice, a fully remote PRRC arrangement requires careful structuring.

Responsibilities​

The PRRC is responsible for ensuring — within the manufacturer or EU REP — that:

  1. The conformity of devices is appropriately checked before release (including applicable conformity assessment procedures, DoC, and CE marking)
  2. The technical documentation and EU DoC are drawn up and kept up to date
  3. Post-market surveillance obligations are fulfilled (including PSUR/PMS reports, PMCF/PMPF, vigilance reporting)
  4. Reporting obligations are complied with — serious incident reports, trend reports, FSCAs
  5. For investigational devices: the applicable requirements are met before clinical investigations or performance studies begin
  6. Any statement made in communications to competent authorities, notified bodies, or other parties on behalf of the manufacturer or EU REP is accurate and not misleading

The PRRC does not personally need to carry out every task — they are responsible for ensuring the system is in place, not for performing all functions themselves.

Can a single person hold multiple roles?​

Yes — subject to the following:

  • In larger organisations, the PRRC is often a dedicated full-time role, possibly shared with senior regulatory affairs management responsibilities
  • In smaller organisations, the PRRC may also hold quality, regulatory, or technical roles
  • In micro and small enterprises (fewer than 250 employees and annual turnover ≤ €50 million, or balance sheet total ≤ €43 million), the manufacturer does not need to have the PRRC permanently available within the company — they may contract an external person as PRRC, provided the external PRRC has appropriate qualifications and is always reachable

The PRRC may not, however, also be the notified body auditor — the independence of the conformity assessment process must be maintained.

Can one PRRC cover multiple manufacturers?​

An individual may act as PRRC for more than one legal entity, provided:

  • They have the capacity to genuinely fulfil the role for each entity
  • Each entity's needs are proportionate to the PRRC's availability
  • The arrangement is documented and transparent

In practice, external PRRCs acting for multiple micro/small manufacturers should have documented time allocation and escalation procedures per client.

What happens if the PRRC leaves?​

The organisation must have a plan for PRRC continuity. If the PRRC leaves:

  • A new PRRC must be designated promptly
  • The transition should be managed without gaps in regulatory oversight
  • Notified bodies typically ask about PRRC succession as part of QMS audits

It is good practice to document the PRRC role in the QMS, including succession planning and interim cover arrangements.

PRRC availability to competent authorities​

The PRRC's name and contact information must be available to the competent authority on request. In practice:

  • EUDAMED registration for the manufacturer or EU REP should reflect current PRRC details
  • The QMS should document who the PRRC is and what their responsibilities cover
  • The PRRC should be reachable for regulatory queries — anonymous or unavailable PRRCs are a red flag in NB and CA inspections

Common misconceptions​

MisconceptionCorrect position
"Our QA Manager is automatically the PRRC"The QA Manager may qualify as PRRC — but only if they meet the qualification requirements and are formally designated
"Our notified body can be our PRRC"❌ No — NBs cannot serve as PRRC; it creates a conflict of interest
"We are a distributor so we need a PRRC"❌ No — only manufacturers and EU REPs need a PRRC
"The PRRC must sign every document"Not necessarily — the PRRC oversees the system; delegation is possible within the QMS
"One PRRC for the whole group"May be acceptable if the group functions as a single legal entity or has documented PRRC sharing arrangements — but legal entities are separate and each technically requires their own PRRC designation

Official references​

ReferenceDescription
MDR Art. 15PRRC requirements
IVDR Art. 15PRRC requirements (IVDR)
MDR Art. 15(3)Micro and small enterprise provisions
MDCG 2019-6Questions & Answers on the PRRC
Commission Recommendation 2003/361/ECDefinition of micro, small, and medium-sized enterprises