PRRC Cost Calculator

Estimate annual PRRC costs for EU MDR/IVDR based on coverage, portfolio complexity, and SLA. Then request quotes from vetted providers.

Request Quotes Do I Need a PRRC?

PRRC-as-a-service pricing varies by regulation (MDR vs IVDR vs both), device class, portfolio size, and how much support you need. Use this calculator as a planning guide; final quotes depend on your exact scope and provider.

Cost Estimator

Use the inputs below to estimate a realistic annual range. This is a planning estimate; providers will quote final pricing.

What Drives Pricing?

PRRC-as-a-service costs depend on several factors. The calculator above applies typical ranges; your quote may be higher or lower depending on provider and scope.

  • Coverage: MDR only, IVDR only, or both—IVDR and dual coverage typically command a premium because of the specialised knowledge required.
  • Device class: Higher classes (IIb, III, IVD C/D) usually require more oversight and documentation review, so pricing scales up.
  • Portfolio size: More products or families increase the volume of conformity checks and documentation review.
  • QMS maturity: If your QMS is still developing or in transition, providers may charge more for the extra support and review.
  • Response SLAs: Faster turnaround (e.g. 24h) typically costs more than standard (48–72h).
  • Languages and geography: Multi-language or multi-market support can add cost.

What’s Included in Typical Plans?

Most PRRC-as-a-service offerings include:

  • Regulatory oversight: The designated person fulfils the Article 15 PRRC role for your organisation.
  • Conformity checks: Checking that devices conform to applicable requirements before release.
  • Technical documentation review: Ensuring technical documentation and EU declaration of conformity are in place and up to date.
  • Post-market surveillance (PMS): Many providers include support for PMS obligations; confirm scope.
  • Vigilance and reporting: Support with serious incident reporting and FSCA may be included or offered as an add-on.

Some providers bundle ongoing compliance support, QMS reviews, or audit preparation. Compare scope when requesting quotes.

PRRC vs EU AR vs CH‑REP (Quick Comparison)

PRRC: Qualified person responsible for compliance inside the manufacturer or AR organization (MDR/IVDR Article 15).

EU AR: EU/EEA legal entity appointed by non‑EU manufacturers (MDR/IVDR Article 11).

CH‑REP: Swiss legal entity appointed by non‑Swiss manufacturers under MedDO/IvDO.

Key point: PRRC is a person; EU AR/CH‑REP are organizations.

FAQ

How often do I pay for PRRC-as-a-service?

Most providers quote on an annual basis (retainer or fixed fee per year). Some offer monthly or quarterly billing. The calculator output is an annual range; confirm payment terms when you request quotes.

Is external PRRC cheaper than hiring in-house?

For micro and small enterprises or small portfolios, external PRRC-as-a-service is often more cost-effective than a full-time hire. For larger companies with many devices, an in-house PRRC may be justified. Compare total cost (salary, benefits, training) with provider quotes for your scope.

What currency do providers quote in?

Many EU-based providers quote in euros (€). The calculator uses € as a typical currency. When you request quotes, confirm currency and whether prices are exclusive or inclusive of VAT.

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This calculator provides planning estimates only and does not constitute legal advice. Cruxi is a marketplace/matching service; we are not a law firm. See our Privacy Policy.