AZ Regulatory

External PRRC — MDR Art. 15

External Person Responsible for Regulatory Compliance on a monthly retainer. Only for micro and small manufacturers meeting MDR Art. 15(4) thresholds.

€1,500–3,500/moretainer · quote after kick-off

monthly agreementclear availability limits

Check External PRRC eligibility WhatsApp

Who it is for

Micro and small manufacturers (indicatively <50 staff, ≤€10m turnover)
Companies without an in-house PRRC
Organisations with real QA/RA processes (not paper-only PRRC)

Who it is not for

Medium/large firms outside Art. 15 thresholds
Paper PRRC without process or documentation access
EUDAMED registration substitute (separate service)

Retainer includes

PRRC function within contract and Art. 15 limits
Compliance reviews on an agreed cycle
Business-hours availability (contract limits)
Escalation and remediation recommendations

EUDAMED ≠ PRRC. Actor/UDI registration is a separate service (EUDAMED Express).

Looking for an External PRRC?

Tell us company size and device class — we check eligibility within 3 business days.

Check eligibility

External PRRC only when MDR Art. 15 thresholds are met. Not a notified body. No guarantee of CE certification or authority inspection outcome.