Person Responsible for Regulatory Compliance: Who Needs One and What Qualifies Them

The person responsible for regulatory compliance is a named individual with defined duties, not a job title assigned to whoever handles paperwork. For a manufacturer it is a requirement under Article 15. For an authorised representative it is also a requirement, and the way each provider meets it is one of the clearer differences between them.

Who needs a person responsible for regulatory compliance

Manufacturers must have available within their organisation at least one person responsible for regulatory compliance who possesses the requisite expertise in the field of medical devices.

Micro and small enterprises are not required to have the person within the organisation, but must have such a person permanently and continuously at their disposal. This is a concession on employment, not on availability.

Authorised representatives must have permanently and continuously at their disposal at least one person responsible for regulatory compliance who possesses the requisite expertise regarding the regulatory requirements for medical devices in the Union. Article 15(6) makes this an obligation of the representative in its own right, separate from the manufacturer's.

[What qualifies a person responsible for regulatory compliance

Article 15(1) sets out two alternative routes, and either is sufficient on its own.

The first is a diploma, certificate or other evidence of formal qualification awarded on completion of a university degree or an equivalent course of study, in law, medicine, pharmacy, engineering or another relevant scientific discipline — combined with at least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices.

The second is four years of professional experience in regulatory affairs or in quality management systems relating to medical devices, without a formal qualification.

The qualification is personal, evidenced and documented. A prospective representative that cannot describe which route its person responsible for regulatory compliance satisfies has not verified it either.

What the person responsible for regulatory compliance does

Within a manufacturer, the duties are set out in Article 15(3). The conformity of devices is appropriately checked in accordance with the quality management system before a device is released. The technical documentation and the EU declaration of conformity are drawn up and kept up to date.

Post-market surveillance obligations are complied with. Reporting obligations for serious incidents and field safety corrective actions are met. For investigational devices, the required statement under Annex XV is issued.

Article 15(5) protects the position: the person must not suffer any disadvantage within the organisation in relation to the proper fulfilment of these duties. This is a structural safeguard, and it is worth asking whether it is real in an organisation where the person reports to the sales director.

Employed or contracted

The regulation permits an external arrangement for smaller organisations and for representatives. In text, both arrangements require permanent and continuous availability. In practice they do not deliver the same thing.

A person responsible for regulatory compliance employed inside the firm answers on the day a competent authority asks a question. A contracted one answers when their other engagements permit, and a contracted person covering twenty manufacturers is available to each of them one twentieth of the time.

When assessing a prospective authorised representative, ask three questions: which arrangement applies, which qualification route the person satisfies, and how many manufacturers that person covers. The answers are more informative than anything in the brochure.

Employed versus contracted person responsible for regulatory compliance and what each means for availability

Sources

Regulation (EU) 2017/745, Article 15 — person responsible for regulatory compliance

Regulation (EU) 2017/746, Article 15

MDCG 2019-7 — guidance on Article 15 of the MDR and IVDR regarding a person responsible for regulatory compliance

Regulation (EU) 2017/745, Annex XV — clinical investigations

Who wrote this

Medex is a medical device manufacturer established in Ankara and a registered authorised representative in EUDAMED under SRN TR-AR-000057550. Our person responsible for regulatory compliance is a partner of the firm, with a deputy for continuity, and carries the same responsibility for our own device portfolio. We are not a law firm and do not provide legal advice.

A manufacturer outside the Union needs a PRRC of its own, and its EU authorised representative needs one too — Article 15(6) requires it. Ours is a partner of the firm, with a deputy for continuity.