As the year 2024 draws to a close, it is time to reflect on the year passed, and start planning and scheduling for the year to come.
The past year to many has seen to be a challenging year, with economy slowing down, and socio-economic aspects being more at the forefront than in recent years. For various reasons, companies in our MedTech field have restructured, and surprisingly even the European Notified bodies have started to reduce their workforce to match the work at hand as quite a few companies paused their MDR and IVDR implementation projects.
On the other hand, legislators have picked up the work around the globe. Gert Bos (CSO of Qserve Group) reflects on some highlights:
- In the USA, we saw the proposal from the FDA to regulate Lab developed tests (LDTs), leading to much debate following the initial concerns from industry. A second impactful change is the guidance on the use of AI, aiming to protect patients and healthcare staff at a time of critical innovation. More guidance also in areas such as remanufacturing and sterility information for medical devices.
- In Europe, the key changes include the plan to gradually role out EUDAMED, the mandatory information to provide early warning on interruption or discontinuation of products and the new transitional provisions for the IVDR, allowing companies more time to come into compliance in a risk-based, scaled approach. Also, the publication of the AI Act has started the transition period into this new era, with opportunities as well as restrictions to the powerful new technologies. And a last thing to note is the debate that was started to fast-track the improvements to the legal framework, including its governance.
- For China, NMPA issued a draft plan to revise around 100 standards, aiming to facilitate local testing and enhance the regulatory submission process. New guidance was published on the clinical evaluation, and of course a new medical device law was proposed in the final quarter of the year, currently in a public commenting phase. It will, among others, aim to increase innovation, and it will facilitate product certificate transfers.
- On a global scale, trends are similar to the above, with many countries adding requirements and/or guidance on cybersecurity, safe use of AI, product traceability, as well as a continued focus to add further chemical restrictions.
Preparing for 2025: Navigating Evolving Regulatory Challenges
Looking ahead into 2025, many of these changed expectations and re-focused priorities will require regulatory effort and diligence.
It is with that in mind that we are launching two new services, Jan van Lochem (CEO of Qserve Group) continues:
- Qserve Learn is a state-of-the-art e-learning platform designed specifically for regulatory, quality, and clinical professionals in the medical device and in-vitro diagnostics (IVD) industry. Offering unmatched flexibility, Qserve Learn allows you to advance your skills at your own pace, anytime and anywhere.
- Secondly, we created Qserve Insight, a software-based regulatory intelligence platform that automatically collects and stores changes in regulatory documents in a centralized database. Our innovative tool simplifies the compliance process, offering timely updates, expert summaries from Qserve’s seasoned professionals, and actionable insights. With Qserve Insight, you’ll stay ahead of regulatory changes and manage compliance in all global markets important to you.
As we move towards the end of the year, we already see many existing as well as new customers move to determine their path forward into 2025, Martin de Bruin (CCO of Qserve Group) adds. Projects towards EU MDR and EU IVDR compliance are picking up speed, and so are FDA submissions; plans for PMCF surveys and for full-blown clinical studies in the pre- and post-market phases are being discussed; and companies start registering their products in more and more countries around the world.
For now, we wish you some refreshing time off and good celebrations into the new year. Looking towards 2025, our global team is there to support you. Looking forward to our (continued) cooperation!
Jan van Lochem, Gert Bos and Martin de Bruin