Identify key roles and responsibilities associated with PRRC-MDR and PRRC-IVDR

RAPS recognizes that there is a need for both employers, and the individuals who work for them, to demonstrate and verify eligibility, experience, and qualifications for the role of Person Responsible for Regulatory Compliance (PRRC), as set out in regulations (EU) 2017/745, MDGC 2019-7, and Article 15.

Consequently, RAPS is creating a qualifications program (PRRC-MDR and PRRC-IVDR) to qualify individuals who are assigned to perform the PRRC job functions.

To that end, RAPS is looking for experts to identify the key roles and responsibilities associated with PRRC-MDR and PRRC-IVDR. As part of this process, these experts will provide input on the knowledge, skills, and abilities required to perform the job functions, also known as a Job Task Analysis (or JTA). The results of the JTA will guide the development of the qualifications program.