Annemieke’s key role as ‘Person Responsible for Regulatory Compliance’ (PRRC)
At Certification Experts, we work with many experts in various fields. One of these experts is consultant Annemieke van Kerkwijk. She plays a crucial role as the ‘Person Responsible for Regulatory Compliance’ (PRRC) within Team Medical. With her extensive knowledge of medical devices and regulations, she helps companies comply with the ever-changing requirements in the sector. But what makes her role so special?
PRRC mandatory since 2021
Since the introduction of the medical device regulation (MDR) in 2021, manufacturers are required to appoint a PRRC. Due to this obligation, the role is becoming increasingly specific and complex. This may seem like a bureaucratic obligation, but it is much more than that. The PRRC is responsible for overseeing compliance with laws and regulations. For many small companies, it can be a challenge to find someone who meets these requirements. This is where Annemieke comes in.
National representative for the PRRC team in the Netherlands
Annemieke not only fulfills the role of external PRRC but is also the national representative for the Netherlands within the PRRC team. “This role is especially important,” she explains. “As a national representative, I am the point of contact for the Dutch market and ensure that the interests of the PRRC’s in Dutch manufacturing companies of medical devices are well represented at the European level.” It is clear that Annemieke has a passion for her profession and is not afraid to get her hands dirty.
Knowledge sharing and networking
Annemieke is not only busy with her own tasks; she also regularly organizes knowledge sessions and meetings. “It is great to bring professionals in the sector together,” she says. During a recent meeting in the Netherlands, organized by Team PRRC NL in collaboration with Certification Experts, both beginners and advanced professionals came together. “Everyone learns from each other, and that is what makes these sessions so valuable.”
As a national representative, Annemieke has access to international meetings. “The annual PRRC meeting, this year in Rome, is always a highlight,” she says. “It is an opportunity to meet colleagues from different countries and learn from guest speakers, including government representatives. This network is essential to stay informed about the latest developments and trends. Next year, it will be in Prague!”
Challenges and experiences
The world of laws and regulations is anything but static. Annemieke must constantly be alert to changes. “The regulations change regularly,” she says. “Take, for example, the recent changes in packaging regulation and electrical regulations. Companies must quickly adapt to these.”
Her work is not only challenging but also varied. She comes into contact with a wide range of companies, from small businesses making simple products like bandage or tape to high-tech companies developing innovative medical devices or software. “One example that stays with me is a device that can take blood without a nurse being needed,” she says enthusiastically. “These kinds of innovations make my role challenging because I have to understand how all aspects of these products comply with regulatory requirements.”
The humor in the role
Annemieke has a down-to-earth view of her work. “Sometimes I feel like Sherlock Holmes,” she laughs. “You have to investigate everything and make sure all the pieces fit. Did you know that condoms and lubricants are also medical devices? It’s surprising how broad the range of products we work with is.” This humor makes her role not only serious but also enjoyable.
The impact of her work
Annemieke is an indispensable expert within Certification Experts and a valuable partner for companies navigating the challenges of medical regulations. “My work is not just my responsibility but something we do together,” she says. “With my combination of knowledge, experience, and network, I can help companies stay compliant.”
Her role as the national representative for the Netherlands in the PRRC team allows her to bridge the gap between national interests and European regulations. “It is a responsibility I take seriously. It’s important to make sure the voices of Dutch companies are heard at the international level.”
With this approach, Annemieke not only contributes to improving systems but also to enhancing collaboration in the sector. For companies preparing for the challenges of medical regulations, one thing is clear: when things get complicated, you can count on Annemieke.
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