What is a PRRC, and do I really need one as a small team?

In short: The PRRC (Person Responsible for Regulatory Compliance, MDR Article 15) is a qualified person accountable for device release, technical documentation, and post-market obligations. Every manufacturer needs one. Micro and small enterprises don't have to employ one in-house — but must have one permanently and continuously at their disposal, and auditors check.

What the role actually covers

The PRRC signs off on conformity of devices before release, ensures technical documentation and the declaration of conformity are current, keeps post-market surveillance obligations on track, and meets vigilance-reporting duties if something goes wrong. Qualification routes are specific: either a relevant diploma plus one year of professional experience in regulatory affairs or quality management for medical devices, or four years of professional experience in those areas without a formal qualification. This isn't a title you assign to whoever's available — the person has to actually meet one of those two bars.

The small-team carve-out, and its limit

MDR Article 15 recognises that not every manufacturer can afford a full-time in-house PRRC. Micro and small enterprises, as defined by Recommendation 2003/361/EC — fewer than 50 employees, under EUR 10 million turnover or balance sheet — don't have to employ one directly. But the requirement doesn't disappear: you must have a PRRC "permanently and continuously at your disposal," which in practice means a documented, accountable relationship, not an informal arrangement you can't produce evidence for on request.

Where teams get caught out

The exposure point is almost always the same: a nominal PRRC named in the QMS who isn't genuinely available or engaged when an auditor or Notified Body asks a substantive question. That gap surfaces at exactly the wrong moment — during an audit, not before one. Deciding early whether to hire, contract, or use a fractional arrangement avoids discovering the answer under pressure.

Where next: PRRC Under MDR Article 15: What to Know · Can an external consultant act as my PRRC?

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