With the EU MDR/IVDR changes on the horizon, RAPS pulled together a workshop in Brussels in May 2018 to focus on preparing for these updates. The intent of the program was to support European regulatory affairs professionals, by bringing them together to discuss and share experience, expectations and concerns in preparing to meet the new EU regulations.
Over 120 registrants signed up to be a part of the workshop, signaling the need for support and guidance through implementation process. Speakers like Gert Bos, Bassil Akra and Anja Wiersma helped provide participants with the skills to create their own transition and implementation plans. RAPS Executive Director Paul Brooks was on hand to give further guidance and help attendees understand all the information channels available to them as they navigated the new process. Feedback from participants has been hugely positive, with many indicating they appreciated the ability to ask questions directly to notified body representatives. This mingling of regulatory professionals and notified body representatives gave many attendees a step up in understanding how the new regulations should be applied.
RAPS is looking forward to continuing to build a community in Europe which can effectively engage and prepare the EU devices and healthcare products RA communities to respond to the changing regulatory environment. Events like this are important to ensure regulatory affairs professionals are informed and prepared to contribute proactively to the ongoing success of the EU healthcare products sector to the benefit of patients and all stakeholders in the EU and globally.