Person Responsible for Regulatory Compliance (PRRC)

What Qualifications must a PRRC have?

 Under Article 15 of the EU MDR and IVDR, a PRRC must demonstrate the appropriate qualifications through a relevant academic background combined with professional experience, or through several years of practical experience in medical device regulatory affairs or quality management systems. The required qualifications must be documented and relevant to the devices and responsibilities involved.

Can a PRRC be outsourced?

Yes, under certain conditions. Micro and small manufacturers can appoint an external PRRC, provided that qualified expertise is permanently and continuously available. Larger manufacturers generally need a PRRC within their organisation, while EU Authorized Representatives must also have qualified regulatory expertise permanently and continuously at their disposal. The right setup depends on your company’s structure and regulatory obligations.

Is a PRRC the Same as an EU Authorized Representative?

Not quite. While both play important roles in European medical device compliance, their responsibilities are different. An EU Authorized Representative acts on behalf of a manufacturer based outside the EU, handling specific regulatory obligations under an agreed mandate. A Person Responsible for Regulatory Compliance (PRRC), on the other hand, is a qualified individual responsible for ensuring oversight of specific compliance processes under Article 15 of the MDR or IVDR.

Can One Person Cover Every PRRC Responsibility?
Yes, provided the individual has the necessary qualifications, expertise, and availability to fulfil all assigned responsibilities. PRRC responsibilities can also be shared among multiple qualified individuals. In that case, each person’s respective areas of responsibility must be clearly defined in writing. What matters most is ensuring effective regulatory oversight, clear accountability, and continuous access to the required expertise.