PRRC Capacity Planning Calculator
Estimate annual PRRC workload based on portfolio complexity, regulatory change frequency, and incident intensity. Use this to decide whether in-house, external, or hybrid coverage is most defensible for your operating model.
Directional planning output. Use formal risk and legal review before final staffing decisions.
Compare +50 PRRC providers PRRC Cost CalculatorCapacity model
Set your baseline assumptions. The model estimates annual PRRC hours and suggests a practical coverage model you can validate with providers.
Interpreting workload output
Low-hour range
Typically fits lean, stable portfolios. Teams often use an external PRRC or part-time internal owner with straightforward escalation procedures.
Mid-hour range
Usually requires stronger governance routines. Hybrid arrangements become useful: internal process ownership plus external specialist coverage during change peaks.
High-hour range
Suggests sustained operational load where single-person setups become fragile. Teams should stress-test backup capacity, surge response, and continuity assumptions before finalizing contracts.
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FAQ
What does annual PRRC hours mean?
It is a directional estimate of oversight effort across conformity checks, technical documentation governance, PMS/vigilance coordination, and change management.
How should I use this before provider selection?
Use the workload estimate as a baseline in provider interviews. Ask how each provider would cover peak periods and continuity requirements with your same assumptions.
Can I run this for both MDR and IVDR portfolios?
Yes. For mixed portfolios, choose the more demanding assumptions to avoid underestimating effort.
Sources
- EU MDR Article 15 (PRRC obligations): https://www.legislation.gov.uk/eur/2017/745/article/15/adopted
- EU IVDR (Regulation (EU) 2017/746): https://eur-lex.europa.eu/eli/reg/2017/746/oj/eng
- European Commission SME definition: https://single-market-economy.ec.europa.eu/smes/sme-definition_en
Disclaimer: Educational planning content only. This page does not provide legal advice.