The person responsible for regulatory compliance is the professional role anchored in the MDR and IVDR that ensures regulatory compliance at the manufacturer or authorised representative. They must have documented expertise and, among other things, oversee conformity documentation, post-market surveillance, and vigilance. The role is often abbreviated as PRRC.
Responsibilities within the manufacturer’s system
The role is not limited to a formal signature. It ensures that product compliance is appropriately verified before release, that the technical documentation and the EU Declaration of Conformity are prepared and kept up to date, and that post-market surveillance obligations are fulfilled. For investigational devices, it also considers the statement on the relevant requirements and the duties set out in the clinical investigation documentation.
The role also includes ensuring that vigilance reporting obligations are met. The responsible person does not have to handle every complaint personally. However, they need access to the information and procedures required to determine whether Quality Assurance, Regulatory Affairs, clinical evaluation, and vigilance are meeting their respective legal obligations. A standalone appointment without the authority to request documents or escalate deviations does not fulfil the practical purpose of the role.
Expertise and organisational integration
The required expertise can be demonstrated by a relevant university degree in law, medicine, pharmacy, engineering, or another relevant scientific discipline, together with at least one year of professional experience in Regulatory Affairs or quality management systems for medical devices. Alternatively, the Regulation specifies four years of professional experience in these areas. What matters is a demonstrable link between the qualification and the medical device or IVD environment.
Manufacturers and authorised representatives must make at least one such person available within their organisation. Several individuals may cover the responsibilities, provided the allocation remains clear. The guidance emphasises that, in larger companies, the appointed person must be an employee of the organisation. Decisions on resources and deputisation therefore belong in the quality management system, not merely in an organisational chart.
Distinction from external support and from the Qualified Person
Micro and small enterprises may have the person responsible for regulatory compliance available externally on a permanent and continuous basis. Larger companies, by contrast, require their own staff. External consultancy can support internal roles, but for them it does not replace the PRRC’s organisational integration. Company size and documented access to the role therefore determine the permissible setup.
The established term “qualified person” refers to the pharmaceutical Qualified Person under medicines law. This role has a different legal basis and a different focus, particularly in connection with batch release of medicinal products. The PRRC does not release batches as a pharmaceutical QP. It supports MDR or IVDR compliance of a medical device throughout its regulatory lifecycle and must therefore not be understood as a mere translation of the Qualified Person.
In practice, the role requires defined reporting lines. It should be able to identify who prepares the release decision, where PMS data are collected, and how reports from sales or service reach vigilance. This does not mean that the PRRC performs every task operationally. However, its responsibility presupposes that it can initiate clarification when documentation is incomplete or safety issues have not been addressed.
Relevance for clinical trials
Before a clinical investigation begins, product status, technical documentation, risk analysis, and the relevant statements must be kept consistent. Changes to design, intended purpose, or instructions for use can have regulatory consequences during recruitment. The PRRC must therefore be able to trace when data from monitoring, safety assessment, or investigational device logistics trigger an update of the conformity documentation. This is particularly challenging when multiple economic operators are involved and the manufacturer and sponsor roles are separated.
Full-service CROs such as Mediconomics provide support through document lists for clinical investigations, tracking of regulatory versions, interface processes between sponsor and manufacturer, and preparation of vigilance-relevant information for the responsible role. They do not replace the legally appointed person, but they can provide a robust basis for reviewing study documentation, changes, and safety reports.
In affiliated companies, it should also be clear which legal entity provides the PRRC and for which products its responsibility applies. A global functional title does not replace an allocation to the economic operators responsible under the MDR or IVDR.
Frequently Asked Questions (FAQ)
Does every PRRC need an academic degree?
No. In addition to a relevant degree with at least one year of relevant experience, the Regulation also recognises four years of relevant professional experience as evidence of expertise.
May a small enterprise appoint an external PRRC?
Yes. Micro and small enterprises may have an external person available on a permanent and continuous basis. The arrangement must enable the tasks to be performed in practice.
Is the PRRC responsible for batch release of a medicinal product?
No. Batch release is the responsibility of the pharmaceutical Qualified Person. The PRRC is a role under medical device and IVD law.
Regulatory References
- Regulation (EU) 2017/745, Article 15 – defines the role and its responsibilities for medical devices.
- Regulation (EU) 2017/746, Article 15 – contains the parallel requirements for in vitro diagnostic medical devices.
- MDCG 2019-7 Rev.1, Guidance on Article 15 – explains expertise, company size, and organisational availability.
- Regulation (EU) 2017/745, Annex VI Part A – covers the registration information for economic operators.
