Can an external consultant act as my PRRC?

In short: Yes — for micro and small enterprises. MDR Article 15(2) requires only that the PRRC is "permanently and continuously at their disposal" rather than within the organisation, and MDCG guidance (MDCG 2019-7) interprets this as permitting a contracted external person, provided they meet the qualification requirements. The accountability is real either way: the PRRC's name and responsibility are documented in your QMS.

What "permanently and continuously at your disposal" means in practice

The carve-out for micro and small enterprises — Article 15(2), as interpreted in MDCG 2019-7; larger manufacturers must keep the PRRC in-house — isn't a loophole that removes the obligation: it changes the employment model, not the substance. Your external PRRC still needs to meet the same qualification bar as an in-house one (a relevant diploma plus a year of regulatory or quality-management experience, or four years of experience without formal qualification), and the arrangement needs to be genuinely available on an ongoing basis, not a one-off engagement you can point to when asked. A contract that names the person and defines their scope of responsibility, review cadence, and availability is what turns "we have someone" into something an auditor will accept.

Why the accountability doesn't get lighter

Whether your PRRC is an employee or a contractor, the responsibilities under Article 15 are identical: conformity sign-off before release, keeping technical documentation and the declaration of conformity current, and staying on top of post-market surveillance and vigilance obligations. An external PRRC who isn't actually engaged with your product — reviewing real documentation, not rubber-stamping — creates the same exposure as a nominal in-house PRRC who never gets asked a hard question. The value of the external route is flexibility and access to experience you couldn't otherwise afford full-time, not a lighter version of the role.

What to look for in an external PRRC

• Qualification route. Confirm which of the two Article 15 routes they meet — diploma plus a year of experience, or four years without formal qualification — don't take "I'm qualified" at face value.
• Scope and availability in writing. A contract naming their responsibilities, review cadence, and how quickly they're actually reachable, not an informal arrangement you can't produce on request.
• Device-type and class experience. A generalist consultant without software or AI-device experience will miss the same things an under-qualified in-house hire would.

On the horizon: a December 2025 Commission proposal to simplify the MDR and IVDR (COM(2025) 1023) would make the external-PRRC route for SMEs explicit in the regulation itself — a proposal, not law, realistically 2027 at the earliest, so the current rules apply.

Where next: PRRC Under MDR Article 15: What to Know · What is a PRRC, and do I really need one as a small team?

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