A PRRC's job is four duties, not a title

Two of this blog's posts on EU economic operators already mention a PRRC in passing — the authorised representative's own duty to keep one, folded into the post covering Article 11's mandate. Article 15 itself, the provision that actually creates the role inside a manufacturer, hasn't had a post of its own. That's worth closing, because the section is easy to read as a staffing line — keep someone on the org chart with the right title — when what it actually specifies is a two-track qualification test, an availability rule that isn't the same as an employment rule, four named duties, and a protection clause aimed at exactly one predictable failure.

Two ways to qualify, no third option

Article 15(1) requires every manufacturer to have at least one person responsible for regulatory compliance available within its organisation, and it sets the expertise bar two ways rather than one. A person qualifies either through a diploma, certificate, or other formal qualification in law, medicine, pharmacy, engineering, or another relevant scientific discipline, plus at least one year of professional experience in regulatory affairs or in quality management systems relating to devices — or through four years of professional experience in regulatory affairs or quality management systems relating to devices, with no diploma requirement at all. A hiring file that only checks for a degree has tested one path and ignored the other the article names as equally sufficient.

Available doesn't mean employed

Article 15(2) carves out micro and small enterprises, as defined by Commission Recommendation 2003/361/EC, from having to keep the person within their own organisation — they still have to have such a person permanently and continuously at their disposal, just not necessarily on staff. Article 15(5) extends the same standard to authorised representatives, who owe their own PRRC under the identical 15(2) test rather than a separate one. A contracted regulatory consultant can satisfy this role for a qualifying small manufacturer; what the article won't accept is no arrangement at all, on the theory that a small enough company doesn't need the function.

The four duties the role actually carries

Article 15(3) is where the role stops being a title and becomes a job: the PRRC has to ensure the conformity of devices is appropriately checked in accordance with the manufacturer's quality management system before a device is released; that the technical documentation and the EU declaration of conformity are drawn up and kept up to date; that the reporting obligations set out in Articles 87 to 91 — the vigilance framework covering serious incidents and field safety corrective actions — are complied with; and, for investigational devices, that the statement required under Section 4.1 of Chapter II of Annex XV is issued. The first duty ties the role to the same technical documentation a design file has to structure around Annex II; the third ties it to the same vigilance clock a serious incident report runs against once a report crosses the reporting threshold. A PRRC job description that names the title without naming these four is missing the actual content Article 15(3) assigns.

A protection clause built for one specific pressure

Article 15(4) requires that the person responsible for regulatory compliance suffer no disadvantage within the manufacturer's organisation for properly fulfilling their duties, regardless of whether they're an employee. The clause exists because the first duty in 15(3) creates a predictable point of friction: a PRRC who won't sign off on a release the quality system hasn't actually cleared is the person standing between a shipment date and a conformity gap someone else wants closed quietly. Article 15(4) names that pressure directly rather than leaving the role's independence to whatever protection an ordinary employment contract happens to offer.

Where this meets the rest of the file

A PRRC role description built around the two qualification routes, the availability-versus-employment distinction, and the four duties Article 15(3) actually assigns is previewed in the launch catalog. If your organisation structures the role differently, the shelf takes that correction directly.