PRRC MDR Service Providers (EU MDR) — Get Quotes

Under EU MDR 2017/745^[1] and EU IVDR 2017/746^[2], all manufacturers must have a Person Responsible for Regulatory Compliance (PRRC) with defined qualifications and responsibilities^[1][2].

This requirement applies to:

• All medical device manufacturers placing devices on the EU market^[1] — PRRC is mandatory for all manufacturers regardless of device class
• All IVD manufacturers placing IVD on the EU market^[2] — IVDR also requires a PRRC
• Manufacturers without qualified in-house staff meeting PRRC requirements^[1] — can outsource PRRC through a service provider
• Small manufacturers who prefer to outsource regulatory compliance — PRRC as a Service can be more cost-effective than hiring
• New market entrants entering the EU market for the first time — PRRC is required before placing devices on the market^[1]

Note: The PRRC must meet specific qualification requirements under Article 15 of MDR^[1]: either a university degree in a relevant field plus at least one year of professional experience in regulatory affairs or quality management systems, or four years of professional experience in regulatory affairs or quality management systems^[1]. The PRRC can be an employee or outsourced through a service provider^[1].

PRRC as a Service (also called PRRC service or outsourced PRRC) typically includes:

• PRRC designation: A qualified individual assigned as your PRRC who meets MDR Article 15 qualification requirements^[1] — the PRRC must be documented and available to competent authorities^[1]
• Conformity checking: Reviewing devices before release to ensure QMS compliance^[1] — the PRRC must verify that devices conform to the technical documentation before release^[1]
• Documentation oversight: Ensuring technical documentation and declarations of conformity are maintained and available^[1] — the PRRC oversees that technical documentation is kept up to date^[1]
• Post-market surveillance: Supporting PMS obligations and periodic safety update reports (PSURs)^[1] — the PRRC ensures PMS procedures are in place and followed^[1]
• Authority communication: Supporting reporting to competent authorities^[1] — the PRRC may be involved in serious incident reporting and field safety corrective actions^[1]
• Change management: Reviewing and approving device changes — the PRRC must review significant changes to ensure continued compliance^[1]
• Availability: Defined availability hours and response times — the PRRC must be available during normal business hours^[1]

Important: The PRRC's responsibilities are defined in MDR Article 15^[1] and cannot be delegated to others, though the PRRC may work with a team to fulfill their duties^[1].

PRRC service pricing (also called PRRC as a Service cost or outsourced PRRC pricing) varies based on several factors:

• Portfolio complexity: Number of devices, device classes (Class I, IIa, IIb, III, IVD), documentation complexity — larger portfolios with higher-risk devices typically cost more
• Availability requirements: Business hours vs. extended hours vs. 24/7 — MDR requires PRRC availability during normal business hours^[1], but extended availability may cost more
• Service scope: Basic PRRC designation vs. comprehensive regulatory support — some providers offer PRRC plus additional regulatory services
• Coverage model: Named PRRC (single individual) vs. team-based coverage (multiple qualified PRRCs) — team models may cost more but offer redundancy
• Change frequency: How often device changes require PRRC review — frequent changes may require more PRRC time and increase costs
• Contract terms: Annual retainer vs. per-device fees vs. hourly rates — retainer models are common for ongoing PRRC services
• PRRC qualifications: PRRCs with advanced degrees and extensive experience may command higher fees

Pricing models: Most providers use an annual retainer model covering PRRC designation and core responsibilities^[1], with additional fees for extra services like comprehensive regulatory support or expedited reviews.

When selecting a PRRC service provider (also called PRRC as a Service provider or outsourced PRRC provider), consider these factors:

1. PRRC qualifications: Verify that PRRCs meet MDR Article 15 qualification requirements^[1] — either university degree plus one year of experience, or four years of regulatory/quality experience^[1]. Request evidence of qualifications.
2. Device experience: Confirm experience with your device classes (Class I, IIa, IIb, III, IVD) and device types — PRRCs with relevant device experience can provide better support^[1].
3. Availability: Check if availability matches your operational needs — MDR requires PRRC availability during normal business hours^[1], but confirm timezone coverage and response times.
4. Response times: Verify SLA for PRRC activities and approvals — the PRRC must be able to review devices before release^[1], so response times are critical.
5. Coverage model: Assess named PRRC (single individual) vs. team-based approach (multiple qualified PRRCs) — team models offer redundancy but may cost more.
6. Additional services: Check if they offer broader regulatory support beyond basic PRRC — some providers offer PRRC plus regulatory consulting, documentation support, or PMS assistance.
7. Contract terms: Review responsibilities, liability, and termination clauses — ensure the contract clearly defines PRRC duties and manufacturer responsibilities^[1].
8. Regulatory expertise: Verify understanding of MDR/IVDR requirements and recent updates — PRRCs must stay current with regulatory changes^[1].

Recommendation: Request references from providers, ask about their largest clients, and verify their PRRCs' qualifications and experience with your device types. The PRRC relationship is critical for compliance^[1], so choose carefully.