PRRC - Person Responsible for Regulatory Compliance

Appoint an EU-Based PRRC (Article 15) — Fast, Audit-Ready Coverage

Onboard in 3–5 business days. SaMD & hardware, Class I–IIb.

Rapid onboarding

Article 15 coverage

Distributor/NB-ready

No PRRC in place? Expect audit findings, distributor/NB onboarding delays, and possible Member-State administrative penalties.

How It Works: Assess → Assign → Comply

Quick readiness check, formal appointment, and ongoing compliance support aligned with Article 15.

Assess

Run the 2-minute PRRC check and receive a readiness score with top fixes.

Assign

We prepare your appointment letter and interface with distributors/NBs as needed.

Comply

Ongoing oversight of Article 15 duties with audit-ready records.

What You Can Expect

Outcomes reflect recent client engagements. They’re indicative, not guarantees; specifics depend on your device, class, and documentation status.

Faster distributor onboarding

Clear Article 15 appointment + contact path reduces back-and-forth during checks.

Example: EU reseller accepted PRRC evidence (appointment letter + responsibility matrix) in the first review cycle.

Audit-ready documentation

Centralized evidence of PRRC oversight supports NB/distributor queries without scramble.

Example: Technical file + EU DoC updates logged with PRRC sign-off visible in QMS.

Operational continuity

Pre-defined escalation for PMS, vigilance and labeling/UDI changes keeps releases on track.

Example: Field safety update triaged and documented within the defined response window.

PRRC Duties (Article 15)

These are the core responsibilities the PRRC oversees. Each line is short and linkable for reference.

Conformity before release: Confirm each device meets MDR/IVDR requirements prior to being placed on the market. #

Quality system support: Ensure the QMS defines, documents, and enables PRRC responsibilities and records. #

Technical docs & DoC: Keep technical documentation and the EU Declaration of Conformity current and available. #

Post-market surveillance: Oversee PMS/PMCF inputs, reviews, and evidence of actions taken. #

Vigilance & FSCA: Support incident trending, reportability decisions, and Field Safety Corrective Actions. #

Labeling & UDI: Verify labeling/UDI changes are controlled, approved, and implemented consistently. #

Stakeholder interfaces: Provide a clear contact path for distributors, importers, notified bodies, and regulators. #

Audit-ready evidence: Maintain appointment, responsibility matrix, and oversight records for review. #

PRRC — Frequently Asked Questions

Answers are concise for quick scanning. For your specific device/class, use the readiness check below.

Do we need a PRRC to sell in the EU?

Yes. EU MDR/IVDR require a PRRC (Article 15) for manufacturers and certain authorized representatives; it’s a formal responsibility with defined duties.

Jump to Readiness Check

How fast can we be onboarded?

Typically in 3–5 business days once core documents are provided (appointment draft, QMS mapping, contacts).

Can this cover SaMD and hardware?

Yes. We support SaMD and hardware across Class I–IIb with Article 15 coverage and ongoing oversight.

Do you interact with distributors or notified bodies?

Yes. We provide PRRC contact details and respond to Article 15 queries during onboarding and surveillance.

Can you mentor an internal candidate to serve as PRRC?

Yes. We can mentor internal staff and provide in-house support while retaining external PRRC coverage as needed.

What if we have no PRRC in place?

You risk audit findings, distributor/NB onboarding delays, and possible Member-State administrative penalties; appointing a PRRC closes this gap.

Must the PRRC be EU-based?

For manufacturers established outside the EU, your authorized representative must have a PRRC; availability in the EU time zone is important for responsiveness.

What does the PRRC actually do day-to-day?

They oversee conformity before release, technical docs & EU DoC currency, PMS/PMCF inputs, vigilance, and labeling/UDI controls (see Duties above).

Which device classes are supported?

We typically cover Class I–IIb devices, including SaMD; if you’re unsure, run the readiness check and we’ll advise in context.

What are our next steps?

Run the 2-minute check for your score and top fixes; then book a 30-minute intro to review gaps and timelines.