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According to Article 15 of the MDR, every manufacturer of medical devices must designate a PRRC (Person Responsible for Regulatory Compliance). The MDR (Medical Device Regulation (EU) 2017/745), which has been in effect since May 26, 2021, is a set of regulations binding across the EU for manufacturers of medical devices. Article 15 stipulates that manufacturers must designate at least one PRRC (Person Responsible for Regulatory Compliance). Nevertheless, this position remains vacant for months in many companies or is filled only on paper. Significant responsibility meets a limited pool of candidates: companies are searching, while experienced professionals are hesitant. This article highlights the actual requirements of the role, identifies the obstacles, and explains what companies and applicants can do to address them.
Article 15 of the MDR provides for two ways to demonstrate the required expertise. The first is a completed degree in law, medicine, pharmacy, engineering, or another relevant scientific discipline, plus at least one year of professional experience in the areas of regulatory affairs or quality management systems for medical devices. The second option is proof of four years of professional experience in these areas related to medical devices. Manufacturers of custom-made devices may instead demonstrate two years of experience in a relevant manufacturing area. In its guideline MDCG 2019-7, the MDCG (Medical Device Coordination Group, the coordinating body of EU member states for medical devices) specifies that the experience must be substantial, current, and relevant to the EU legal framework. A job title on a resume is not sufficient.
The PRRC must, at a minimum, ensure that
The word “ensure” is important here: The PRRC does not have to sign off on every approval itself. Instead, it can use spot checks and audits to verify that the processes are working. To this end, it works closely with the Regulatory Affairs, Quality Assurance, Production, Clinical Evaluation, Legal, and Executive Management departments.
Anyone looking for an expert profile covering all product classes and all Notified Bodies (independent testing organizations that assess the conformity of medical devices) is unnecessarily narrowing the market. It makes more sense to distinguish between what must be in place from day one and what can be developed over time. Required qualifications include formal certification in accordance with Article 15 of the MDR, practical experience with the MDR, QMS experience, and sufficient time to dedicate to the role. Detailed knowledge of specific product classes or experience with a particular Notified Body can be developed over time. For candidates, this role offers visibility all the way up to senior management and is often the next step toward leading the “Regulatory Affairs” or “Quality” departments.
There is a widespread belief that the PRRC is personally liable for all violations committed by the manufacturer. However, the MDR does not support this view. Responsibility for product conformity remains with the manufacturer as an organization. The MDR even explicitly protects the PRRC, as Article 15(5) stipulates that the PRRC shall not suffer any adverse consequences for the proper fulfillment of their duties, regardless of whether they are employed by the manufacturer or not.
Nevertheless, the role is not without risk. Personal liability is not regulated by the MDR but is governed by national law. Depending on the breach of duty and the organizational structure, issues under labor law, civil law, or criminal law may arise. Involvement in audits, interactions with regulatory authorities, and internal investigations is also part of the job. Violations primarily affect the manufacturer: corrective actions by regulatory authorities, sales restrictions, recalls, and reputational damage are the consequences. The PRRC is intended to identify and escalate such risks early on; it is not meant to absorb them alone.
In conversations with candidates, we regularly find that they perceive the personal risk to be higher than what the MDR anticipates. Nevertheless, this uncertainty acts as a deterrent. The most common real problem is having responsibility without the necessary authority, resources, or safeguards. Companies that wish to make this role more attractive should document a clear reporting line to senior management, establish decision-making and escalation rights in writing, and provide a binding commitment to legal support for matters involving government agencies. Insurance coverage, such as through D&O or financial loss liability insurance, should be clarified in advance with the legal department and the insurer. Candidates should clarify precisely these points in writing before signing the contract.
The target group is small. We are looking for individuals with regulatory experience, a background in medical devices, an understanding of QMS, and sufficient seniority. Most of them are permanent employees and would not switch jobs just for a new job title. The market is dominated by passive applicants, that is, professionals who are not actively looking but are open to interviews. They are rarely reached through job boards.
Internal development is worthwhile if there are enough experienced professionals in-house from the Regulatory Affairs or QA departments. Prerequisites for this include a formal review of qualifications in accordance with Article 15, targeted continuing education, relief from previous responsibilities, and mentoring by an experienced PRRC or external experts. However, taking on the PRRC role in addition to full-time day-to-day work is not a viable development model.
Hybrid models are helpful when no one within the company yet meets the requirements. An experienced individual assumes the PRRC role while an internal trainee is being developed in parallel. This depends on the size of the company. Micro and small businesses are not required to employ a PRRC themselves. They may contract an external individual, provided that person is permanently and continuously available. For all other manufacturers, Article 15 requires a PRRC within the organization who, according to MDCG 2019-7, is employed by the company. An interim solution, i.e., the temporary appointment of experienced specialists, must therefore be integrated into the organization.
In our industries, we observe that companies with transparent job postings receive significantly more qualified responses. This includes the position within the organizational chart, the product portfolio and risk classes, decision-making authority, and compensation commensurate with seniority. Before accepting an offer, candidates should inquire about which decisions the PRRC is authorized to make independently, to whom they report, and how conflicts between sales and compliance are resolved. You can find more information about the profiles we’re looking for on our page QM / QA / RA / Medical Affairs in Medical Technology.
The PRRC is mandatory for every manufacturer. As long as significant responsibility is coupled with limited authority and unclear guidelines, this bottleneck will persist.
Companies should establish internal development pathways early on, rather than waiting until under audit pressure, and equip the role with genuine decision-making authority and resources. Candidates with MDR experience will be in demand for years to come. They should document the authority, reporting structure, and safeguards in writing before signing a contract.
If you are looking for qualified and motivated professionals and executives for your company, we can support you with our specialized network. Especially in the areas of regulatory affairs and MDR compliance, we have direct access to experienced candidates who do not respond to job postings. For over 15 years, the recruitment consultants at BESTMINDS have been filling vacancies in the medical technology, healthcare, life sciences / pharma, IT / media, and energy / utility sectors with a wealth of expertise and dedication. We find the right candidates for you in a fair, loyal, and discreet manner. Contact us for a no-obligation initial consultation so that we can fill your vacancies quickly and effectively.
