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Why and why now?

RAPS’ goal is to offer the most relevant and sought-after global certification programs for regulatory compliance. The creation of the Person Responsible for Regulatory Compliance (PRRC) role was a catalyst for development. The PRRC role, mandated in Article 15 of the EU MDR and EU IVDR,  requires all manufacturers and Authorized Representatives to have a designated employee responsible for regulatory compliance.

What value do the certifications offer?

These new RAPS regulatory compliance certifications will provide objective third-party validation by way of an exam. Individuals who pass the exam will be able to show the world they know compliance regulations related to In Vitro Diagnostics or Medical Devices. It signals that they have gained a foundational understanding of these regulatory essentials. These certification programs will help institutions bolster their compliance practices and provide practitioners with the knowledge needed to add more value to the compliance function.

What is the process?

Successful completion of the following steps is required to earn and maintain the certification:
The individual applies to the program and meets the eligibility criteria. The individual passes the exam. The individual must recertify to maintain the certification.

Who are the certifications intended for?

These certifications are intended for individuals who need or want to demonstrate that they are compliance professionals in the Medical Device or In Vitro Diagnostics area and that they are keeping pace with industry regulations. Individuals must meet certain prescribed eligibility requirements.

What input was considered?

RAPS has a responsibility to its members and the global regulatory profession to provide meaningful programs. Member and non-member input was considered. An expert task force of industry leaders convened to discuss early concepts and if these certifications were needed. In our research, we found that nearly 75% of employers, as well as those seeking to serve in a quality assurance role or PRRC role, would welcome voluntary certification.

How is this different from the RAC?

The RCC programs are much narrower in scope compared to the RAC credentials and are specific to certain roles. The RAC is broader in scope and tests a much larger body of knowledge needed for a variety of roles across the profession. Individuals can obtain the RCC, the RAC, or both sets of credentials depending upon the fit.

Is the credential required?

No. The credential will not be required. It is strictly voluntary.

Is training required?

No. While we highly recommend that people study for the exam, training courses are not required. They are strictly voluntary.

Do these certifications have a geographic focus?

These certifications are designed to validate knowledge of the regulations put forth by the European Commission. However, the audience is intended to be global since organizations around the world must comply with these regulations.