4 things the first-ever RCC credential holders want you to know
The Regulatory Compliance Certification (RCC) is RAPS’ new credential, released in 2023, designed for regulatory professionals interested in validating their knowledge of European regulations related to in vitro diagnostics (IVDs) or medical devices.
The 70 professionals who passed the RCC exams in autumn 2023 became the first individuals to ever earn the RCC-MDR or RCC-IVDR designation. The RCC-MDR credential is intended for professionals who work in medical devices, while the RCC-IVDR credential is for professionals who work with IVDs.
The creation of the Person Responsible for Regulatory Compliance (PRRC), mandated in the mandated in Article 15 of the EU Medical Device Regulation (MDR) and EU In Vitro Diagnostics Regulation (IVDR), was a catalyst for the development of these credentials. RAPS worked with regulatory professionals to develop these voluntary credentials, which provide validation that a certification holder understands these regulations.
We spoke with five regulatory professionals who earned their RCC credentials to get their takeaways, from the value of sitting for the exam to the study processes they used, and more.
Interested in getting your RCC? Learn more about these new credentials here.
Your RCC is an opportunity to validate your credibility and showcase your knowledge
The RCC-MDR was the first professional exam Stuart Elliott took in his 25-year career.
As the director of regulatory affairs at Haleon, Elliott has been working on EU MDR for years. This was a chance to prove his knowledge in a way that was specifically tailored to European regulations, which is where he spends his time.
“When I saw this come up, I felt that it was a good opportunity for me to show firstly to my managers that I knew what I was doing — and I wasn't just turning up each day and bumbling through,” Elliott said. “But also, I thought it was important to show the people I manage that this is an opportunity they could take advantage of as well. They can go do something like this and can get that professional credential.”
RAPS is now accepting applications for the 2024 RCC exams. Learn more about the RCC exam schedules, application instructions, and more.
Natalie Pupunu, RCC-IVDR, a regulatory affairs director at bioMérieux, had a similar experience.
“I have spent five or six years sitting in conference rooms doing a deep dive into the requirements, making trace matrices, brainstorming on what processes need to be updated or what needed to be created,” she said. “When I saw there was a new exam specific for IVDR compliance, I was really excited to test the work that I have been doing for five years.”
The regulations themselves are useful study resources
While Charles Chiku, RCC-IVDR, a technical officer at the World Health Organization, decided to study for his exam, he found useful information in going through the text of the IVDR itself.
"Initially I had to go through the regulations to get a high-level overview of the critical domains,” Chiku said. “Then when focusing on the exam preparation, I followed the RAPS Study Checklist focusing on the critical domains for the various sections of the regulations.”
Going through the MDR or IVDR, depending on which exam you’re taking, is a simple idea. But that doesn’t mean it is easy.
“The RCC will seriously challenge your grasp of the regulations,” said Jonathan Leo, RCC-MDR, systems verification engineer at Smith + Nephew. “Reading the many clauses of the MDR is a daunting task, so it will be tempting to just skim it for its general principles. While that could be helpful for a first pass, I would recommend multiple reads to know the more granular details well."
Whether you’re studying alone or with a group, there are a few ways to bring the regulations to life and make them a bit less intimidating.
“As I studied, I developed a lot of visuals to help with mapping out different requirements as far as economic operators go,” Pupunu said. "A lot of the primary text in legislation can be really burdensome to read, so creating tools and guides for yourself to help you remember that information was crucial to me.”
Your coworkers and colleagues are useful resources, too
After he read through the EU MDR, Elliott sought out a few trusted colleagues who had deeper knowledge of specific areas to balance out his broad knowledge.
"I spoke to a few people internally who have better knowledge than me because they're specialists in the work that we do in clinical studies and then around the work that the legal manufacturer does,” he said. "I had conversations and said to them, ‘talk me through this.’”
The exams are focused on EU regulations, but the lessons are universal
While some RCC holders decided to earn their credentials because they mainly deal with the EU market, others decided to get the credentials because of the global impact of the EU MDR and EU IVDR.
“The reality is that MDR is influencing regulations internationally,” said Katie Blank, RCC-MDR, an associate regulatory affairs manager at BD. "It's not just EU, it's not just US, it's globally. I wanted to make sure that I had a good understanding of the EU regulations so I could see how they're shaping regulations in other countries.”
The cascading effects of the EU MDR and EU IVDR will be felt across the world and referenced in documents around the world.
Leo also said his work is not focused on the EU, but that he is "now more confident in my understanding of MDR, and in picking apart requirements in a complex regulatory document like REACH, to convey that to other stakeholders or other functions.”