Does this tool confirm legal compliance?

No. It is a planning tool to organize evidence and next actions. Formal legal and regulatory review is still required.

Can an external provider supply the PRRC?

For micro and small enterprises, the regulation allows an external PRRC to be permanently and continuously at the organisation's disposal.

What usually causes low readiness scores?

Missing evidence of education or experience, unclear role coverage between MDR and IVDR, and no documented backup/escalation process.

PRRC Qualification Readiness Calculator

Use this calculator to score how ready your organisation is to designate a compliant PRRC under EU MDR/IVDR Article 15. It helps teams identify documentation gaps before audits, notified-body reviews, or provider onboarding.

Directional planning tool only. Final compliance depends on your documented evidence and legal interpretation of your specific operating model.

Compare +50 PRRC providers Do I Need a PRRC?

Calculator

Answer six questions. The output gives a score, risk tier, and prioritized next actions you can use during internal reviews or provider interviews.

Qualification pathway evidence Regulatory scope covered Technical documentation access control

PMS and vigilance handoff quality Backup coverage and continuity Evidence package audit-readiness

How to use this score in practice

1) Treat score as interview preparation, not final verdict

Teams get the most value when they run this tool before speaking with providers or finalizing in-house designation. A higher score means your governance evidence is easier to defend. A lower score means you should close documentation and ownership gaps before relying on one person for all obligations.

2) Focus on evidence quality, not title quality

Article 15 is about qualification and responsibilities, not job title branding. Strong readiness comes from provable qualification records, clear scope boundaries, and working escalation controls that hold up during incidents.

3) Convert gaps into a remediation checklist

If your score is medium or low, translate the output into dated actions: qualification file refresh, role-letter update, SOP cross-reference map, and continuity coverage. This turns abstract "readiness" into auditable work items.

Related PRRC tools

FAQ

Does this score prove compliance?

No. It helps structure evidence and priorities. Legal/regulatory review is still required before market decisions.

Can one PRRC cover both MDR and IVDR?

Potentially, yes, if qualifications and practical capacity are sufficient for the portfolio and obligations. Scope clarity and workload realism are critical.

What if my records are incomplete?

Use the output action list to close gaps first, then rerun the score. Most teams improve quickly by standardizing qualification evidence and continuity controls.

Sources

EU MDR Article 15 (Person responsible for regulatory compliance): 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.