Person Responsible for Regulatory Compliance (PRRC)
Person Responsible for Regulatory Compliance (PRRC)
A PRRC, or Person Responsible for Regulatory Compliance, is a vital role within organizations — especially in highly regulated sectors like the medical industry. The PRRC ensures that the company complies with all applicable laws and regulations governing its products and operations. Their responsibilities include keeping up to date with regulatory developments, overseeing the accuracy and maintenance of technical documentation, managing post-market surveillance activities, and reporting any incidents to the appropriate authorities. By fulfilling these duties, the PRRC helps the organization maintain compliance and operate within the legal framework.
Summary
A quick overview of this page
What is PRRC?
Having a Person Responsible for Regulatory Compliance (PRRC) is a mandatory requirement under Article 15 of the EU Medical Device Regulation (MDR) 2017/745. This role is critical for organizations, especially in the medical sector, where strict adherence to regulatory requirements is essential.
The responsibilities of a PRRC
Article 15 of the Medical Device Regulation (MDR) defines the responsibilities of the Person Responsible for Regulatory Compliance (PRRC). Under this article, the PRRC is accountable for ensuring that the organization complies with the MDR and any other applicable regulatory requirements.
Outsourcing the role of the PRRC
Outsourcing the PRRC role to an expert consultant from Certification Experts offers organizations specialized regulatory expertise, cost-effectiveness, flexibility, and reduced compliance risks — ultimately enhancing both compliance and overall operational efficiency.
Outsourcing the role of the PRRC
Outsourcing the role of the PRRC to our specialized consultants can offer several benefits:
Expertise
Cost-Effectiveness
Flexibility
Objectivity
Efficiency
Risk Mitigation
Focus on Core Activities
PRRC & MDR
The Person Responsible for Regulatory Compliance (PRRC) is a cornerstone of Medical Device Regulation (MDR) 2017/745 compliance, serving as the key link between medical device manufacturers and regulatory authorities. Under Article 15 of the EU MDR, manufacturers are legally required to appoint a qualified PRRC with the necessary expertise and organizational authority to ensure full adherence to regulatory obligations.
Beyond fulfilling core regulatory obligations, the PRRC serves as the organization’s strategic compliance partner, proactively monitoring evolving MDR requirements and industry best practices. This forward-looking role ensures manufacturers don’t just meet current standards but anticipate and adapt to regulatory changes.
Serving as the critical nexus between corporate operations and regulatory mandates, the PRRC fundamentally transforms MDR compliance from a checkbox exercise into a strategic organizational capability.
PRRC Responsibilities
Article 15 of the Medical Device Regulation (MDR) defines the critical role of the Person Responsible for Regulatory Compliance (PRRC). This key position ensures that manufacturers maintain full compliance with MDR requirements and applicable regulatory standards.
- The PRRC must verify that all medical devices undergo proper conformity assessment procedures as mandated by the MDR prior to market release or clinical implementation.
- Ensuring continuous compliance of medical devices across all lifecycle stages, including the management of post-market surveillance systems as required by MDR Article 83.
- Maintaining current and compliant technical documentation and EU declarations of conformity in accordance with MDR requirements
- Guaranteeing timely fulfillment of all mandatory incident reporting obligations under MDR Article 87
- Maintaining continuous surveillance of evolving regulations and implementing proactive compliance measures to address new requirements.
As the regulatory cornerstone of medical device compliance, the PRRC ensures full alignment with MDR mandates, safeguarding both patient safety and market access across the EU.
PRRC requirements
Medical device manufacturers are required to designate a qualified individual within their organization to manage regulatory compliance. This role demands specific educational credentials and professional expertise.
- A diploma, certificate, or other proof of formal education, obtained after completing a university degree or a study program that the relevant Member State considers equivalent, in fields such as law, medicine, pharmacy, engineering, or another appropriate scientific area, along with at least one year of professional experience in regulatory affairs or in managing quality systems for medical devices.
- Four years of professional experience working in regulatory affairs or quality management systems related to medical devices.
Without affecting any national rules on professional qualifications, manufacturers of custom-made devices can show they have the necessary expertise mentioned above by having at least two years of relevant professional experience in a related manufacturing field.
Micro and small enterprises, as defined by Commission Recommendation 2003/361/EC, are not obliged to employ a person responsible for regulatory compliance within their own organisation, but they must always have such a person available to them on a permanent and ongoing basis.
Similarly, authorised representatives must always have at least one person responsible for regulatory compliance permanently and continuously available, and this person must have the necessary expertise on the EU regulatory requirements for medical devices. This expertise must be proven by one of the specified qualifications.
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