Regulatory Open Forum

 RAPS recently unveiled two new credentials for regulatory professionals: The Regulatory Compliance Certification for Medical Devices (RCC-MDR) and In Vitro Diagnostics (RCC-IVDR).  These new credentials will help institutions bolster compliance and risk mitigation practices and provide practitioners with the knowledge needed to add more value to the organizations they serve. 

The creation of the Person Responsible for Regulatory Compliance (PRRC) role was a catalyst for the development of these credentials. The PRRC role, mandated in Article 15 of the EU MDR and EU IVDR, requires all manufacturers and authorized representatives have a designated employee responsible for regulatory compliance. These designations do not qualify individuals to serve in the PRRC role, nor do they guarantee that an individual meets all the requirements necessary to practice as a qualified PRRC. 

What these voluntary designations do offer is validation that a certification holder understands these regulations. These credentials will have a global reach given that organizations around the world must comply with these regulations in relation to devices placed on the market in the EU. 

On behalf of RAPS, we’d like to thank all of the regulatory professionals who helped to create these certifications and Team-PRRC for providing their expertise.  

Read more about these credentials here.