On 8th and 9th May 2023 I took part in something that I think could be a huge step forward in providing a credential for Regulatory professionals looking to move into or already covering the role of Person Responsible for Regulatory Compliance (PRRC). The RAPS regulatory compliance certification programme. The IVD regulation is clear as to the requirements that the PRRC must have in education and experience. However, the minimum level of degree level qualification in law, medicine, pharmacy or other scientific discipline and one year’s regulatory or quality specific IVD experience is not, in my opinion, enough to equip an individual for this highly responsible role.
The Regulatory Affairs Professional Society (RAPS) has been offering the Regulatory Affairs Certification (RAC) since 1991 and in 2019 they initiated the Device specific RAC. The introduction of this credential has gained traction and is often stated as preferred that a candidate holds this credential in US job adverts. With the PRRC role now being a requirement for compliance to the IVD Regulation in the EU RAPS has again risen to the need for a tangible credential which demonstrates an in depth knowledge of the IVD Regulation 2017/746 or the Medical Device Regulation 2017/745.
The process that I was involved with was to provide subject matter expertise, along with other SMEs, to review each of the questions constructed for this new certification examination. We were given the instructions to review for content, and accuracy, to check source references and also provide wording for adjustment to any questions we considered required amendment. This process took two full days, carefully checking and also identifying where questions had been repeated, or where there may be too many questions focussed on the same area.
I really enjoyed the chance to work with a group of experts, from many different backgrounds, to ensure that the final collection of questions would provide a true test of an individual’s knowledge of the IVD Regulation and hence a pass would provide a clear credential for public scrutiny. While there is no suggestion that this new certification programme should be made compulsory for those wishing the be a PRRC it can go a long way to provide confidence that someone is ready to perform in this role
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