Medical device consultant: What is a Person Responsible for Regulatory Compliance

Friday, May 7, 2021

What is a Person Responsible for Regulatory Compliance

The Person Responsible for Regulatory Compliance is one of the new requirement of the EU MDR European Medical Device Regulation and In-Vitro Diagnostic Regulation 2017/745 and 2017/746. As the European Union’s (EU) Medical Device Regulation (MDR) and In-Vitro Diagnostic Medical Device Regulation (IVDR) continue to evolve, one requirement is getting a lot of attention – the person responsible for regulatory compliance (PRRC).

This individual (or individuals) is one of the newly introduced requirements of the MDR/IVDR and their presence is to ensure that companies have a qualified regulatory expert at their disposal. If a company consists of more than one legal manufacturer, each legal manufacturer must appoint its own PRRC. Both the MDR and the IVDR require a “person responsible for regulatory compliance” (PRRC).

The role of the person responsible for regulatory compliance (PRRC)

The role of the Person Responsible for Regulatory Compliance is defined in Article 15 of the EU MDR (2017/745). MDR requires medical device manufacturers to appoint a designated employee with regulatory expertise to ensure compliance with the EU MDR.

Does every medical device manufacturer require a PRRC?

The mandate to appoint a Person Responsible for Regulatory Compliance depends on the size of your organization. The MDR provides an exception for small manufacturers. Medical device manufacturers with fewer than 50 full-time employees (globally) and under 10 million Euros in global sales revenue (not just EU) are not required to have a Person Responsible for Regulatory Compliance within the company.

Who should employ a Person Responsible for Regulatory Compliance?

Micro and small companies should have permanent and continuous access to the services of such a person. The service can be outsourced. Larger companies should have such a person within their organization.

The requirements for the person responsible for regulatory compliance differ depending on the type and size of the economic actor and the role. With the persons responsible for regulatory compliance, the MDR and IVDR have introduced a role whose responsibility and importance goes far beyond that of the safety officer.