The Person Responsible for Regulatory Compliance is the function designated under Article 15 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746 that, within the manufacturer’s organisation, is accountable for compliance with medical device legislation. In English usage, it is referred to as the Person Responsible for Regulatory Compliance, abbreviated PRRC. The catalogue of tasks, qualification pathways and the facilitation for micro and small enterprises are set out in detail in the entry Person Responsible for Compliance with Regulatory Requirements and are not repeated here. This entry addresses the relationship—often confused in practice—between this product-regulatory role and the designated persons under pharmaceutical law, in particular the Qualified Person responsible for pharmacovigilance.
Legal classification of the role
Article 15(1) requires manufacturers to have at least one person within their organisation with the requisite expertise; paragraph 2 allows micro and small enterprises within the meaning of Recommendation 2003/361/EC to rely on such a person on a permanent and continuous basis without employing them. Paragraph 3 assigns five minimum responsibilities to the role, including conformity checks prior to product release, maintaining the technical documentation and the EU declaration of conformity, and fulfilling the reporting obligations under Articles 87 to 91. Paragraph 5 clarifies that the person must not suffer any disadvantage as a result of properly performing their duties. The MDCG 2019-07 guidance, Revision 1 of December 2023, specifies evidence of qualifications, multiple appointments and the permissibility of external performance.
Distinction from the Qualified Person responsible for pharmacovigilance
The Qualified Person responsible for pharmacovigilance, abbreviated QPPV, is a function under pharmaceutical law. The obligation to appoint follows from Article 104(3)(a) of Directive 2001/83/EC: the marketing authorisation holder must have permanently and continuously at its disposal a qualified person residing and operating in the Union who establishes and maintains the pharmacovigilance system. For centrally authorised medicinal products, Article 23 of Regulation (EC) No 726/2004 supplements this obligation. Implementing Regulation (EU) No 520/2012 anchors the person within the pharmacovigilance system master file framework: Article 2 requires the master file to include details of the qualified person, Article 4 obliges immediate notification to the European Medicines Agency of any change of name or contact details, and Article 7 requires their continuous access to the master file. By contrast, the pharmacovigilance quality system is governed by Article 8 of the same Regulation.
Structural differences between the two functions
The differences are structural, not merely terminological. The QPPV is registered with authorities and named in the master file; they must be continuously reachable and are responsible for assessing individual safety signals, up to and including changes to the product information. The person under Article 15 is not published by name in a dedicated European register; they are responsible for ensuring that the manufacturer’s vigilance processes function, but they do not decide on the continuation of a marketing authorisation, because medical devices are not authorised but placed on the market via conformity assessment. Conversely, pharmaceutical law does not provide for a function responsible for the currency of technical documentation and a declaration of conformity.
Companies with medicinal products and medical devices
Groups with both product categories must staff both functions separately or at least document them separately. Combining the roles in one person is not legally prohibited, but in practice is rarely sustainable because availability requirements, reporting deadlines and reporting cycles are scheduled differently. For substance–device combinations, the separation must be drawn particularly carefully: Article 117 of Regulation (EU) 2017/745 amended Annex I to Directive 2001/83/EC so that, for integral medicinal product–device combinations, the marketing authorisation dossier must include an opinion from a Notified Body on the device part. The boundary of responsibility then runs through the middle of the dossier, and the division of tasks should be set out in writing in accordance with Article 15(4).
Evidence in audits and inspections
Auditors and inspectors expect a job description, evidence of qualifications, an arrangement for deputies, and proof that the person is actually involved in release decisions. Where the role is performed externally, the contract, the agreed availability and the access rights to documents must be evidenced. Where a QPPV also exists, an interface matrix is recommended that specifies, for each type of report, the responsible role, the deadline and the target system.
Relevance for clinical trials
In clinical investigations of medical devices, the role is directly involved: under Article 15(3)(e), it is responsible for ensuring that the statement pursuant to Annex XV, Chapter II, Section 4.1 is issued for the investigational device. This means it is involved in the application documentation without itself assuming the sponsor function. If a product is combined with a medicinal product in a study, the reporting pathways run in parallel: serious adverse events of the medicinal product follow the pharmaceutical-law pathway, while device-related events follow the pathway under Article 80.
Sponsors should therefore clarify at an early stage which designated person signs which statement and how events are assigned to a category. Full-service CROs such as Mediconomics support sponsors and manufacturers in defining this roles-and-reporting matrix before study start and in establishing the associated documentation in an audit-ready manner.
Frequently Asked Questions (FAQ)
Can one person be both the person responsible under Article 15 and the Qualified Person responsible for pharmacovigilance?
There is no explicit prohibition, but both roles require continuous availability and in-depth expertise in different areas of law. A dual appointment is only justifiable for a very small portfolio and with a documented deputy arrangement.
Is the person responsible registered by name with authorities?
The data is collected as part of the registration of economic operators and maintained internally. Public disclosure by name, as is the case with pharmaceutical master documentation, is not intended.
Which provision governs the pharmacovigilance quality system?
Article 8 of Implementing Regulation (EU) No 520/2012. The details on the qualified person itself are set out in Article 2, and their continuous access to the master file in Article 7.
Regulatory References
- Regulation (EU) 2017/745, Article 15 and Annex XV, Chapter II, Section 4.1
- Regulation (EU) 2017/746, Article 15
- Directive 2001/83/EC, Article 104(3)(a); Regulation (EC) No 726/2004, Article 23
- Implementing Regulation (EU) No 520/2012, Articles 2, 4, 7 and 8
- MDCG 2019-07 Rev. 1, Guidance on Article 15 MDR/IVDR, December 2023
