What are the functions of PRRC

The Person Responsible for Regulatory Compliance (PRRC) plays a crucial role in ensuring compliance with MDR or IVDR by overseeing the following aspects:

• Technical Documentation
• Quality System
• System for Collecting and Updating Clinical Data
• Post-Registration Surveillance System

It is essential that all PRRC activities are well-documented, and evidence of these activities must be provided to Competent Authorities upon request. In case of any deviations or inconsistencies, the PRRC takes prompt action to develop and initiate measures aimed at ensuring or restoring compliance.

Does the PRRC have to be an employee of the company?

The designation of the responsible person can be done from within the company's employees. Nevertheless, smaller medical device companies have the option to enlist a third-party service to fulfill the PRRC functions.

Qualifications of PRRC

The role of PRRC is not open to everyone. The Person Responsible for Regulatory Compliance must possess appropriate qualifications, such as education in fields like medicine, biotechnology, etc., and a diploma recognised in Europe. Additionally, experience in European regulatory affairs and/or quality management for medical devices is essential for fulfilling this role.