Introducing the Regulatory Compliance Certifications, two new credentials for regulatory professionals
RAPS today 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 are designed to provide regulatory professionals with third-party validation of their knowledge of regulatory essentials and to provide institutions with tools to bolster their compliance practices.
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.
“I believe that having these external qualifications—which involve delving deep into the regulation to understand the requirements in intimate detail and having that knowledge tested in a formal qualification— will give any employer confidence that a professional knows what they’re talking about,” said Nancy Consterdine, an expert who participated in exam development.
Who should consider taking an RCC exam?
How were the RCC credentials created?
Team-PRRC, an association created to represent and help PRRCs to assume this new profession more confidently, assisted RAPS by providing deep subject matter expertise and thought leadership.
Two groups of SMEs helped RAPS build the exams at an in-person exam development session in Amsterdam this past May.
"Being in a meeting room with people from other parts of the world to discuss this and create a good result was really encouraging and a lot of fun to do,” said René Drost, an expert who participated in exam development.
Passers of the RCC-IVDR exam will be awarded the RCC-IVDR designation, while those who pass the RCC-MDR exam will be awarded the RCC-MDR designation.
There are three steps required to earn and maintain these certifications:
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Meet the eligibility requirements and apply to the program
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Pass the exam
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Recertify every three years
The first RCC exams will launch this autumn. The deadline to sign up for an autumn exam is 5 October.
How is the RCC different from the Regulatory Affairs Certification (RAC)?
The new RCC credentials are focused on specific job roles. The exam content is much narrower in scope compared to the RAC. The RCC and the RAC programs also have different eligibility requirements.
What are the RCC eligibility requirements?
RCC-MDR:
One of the following educational and experience requirement combinations is required to apply:
• Bachelor’s, Master’s, or Doctorate Degree in medicine, pharmacy, engineering, or relative sciences + one year of regulatory-related experience* with medical devices.
OR
• Four years of regulatory-related experience with medical devices.
RCC-IVDR:
One of the following educational and experience requirement combinations is required to apply:
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Bachelor’s, Master’s or Doctorate Degree in medicine, pharmacy, engineering or relative sciences and one year of regulatory-related experience* with in vitro diagnostics.
OR
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Four years of regulatory-related experience with in vitro diagnostics.
*Regulatory-related experience may include quality assurance, quality control, clinical research related to the approval of health products, or health product project management.
How do I learn more about the RCC?
The RCC-MDR Candidate Guide and RCC-IVDR Candidate Guide contain details on everything from the application and scheduling process to deadlines and what to know on exam day. Each guide is available for download below.
Download the RCC-MDR Candidate Guide here
Download the RCC-IVDR Candidate Guide here
Interested in finding out whether an RCC is right for you? Attend this webcast on 31 July to learn more.