As the year draws to a close, it is time to reflect on the year passed and start planning and scheduling for the year to come.
Looking back at 2025, continued socio-economic aspects form part of our regulatory world, but slowly, the MedTech field is adjusting to this as a reality. Systems and funding appear to be stabilizing, and a growing number of companies is picking up the pace to start or finalize compliance programs, EU MDR and IVDR submissions, and other global market approvals. For high-risk innovative devices, the barrier to initiating clinical studies is being lifted, and discussions are starting to finally get the required pre- and post-market clinical data.
Supporting this upward trend, legislators around the world have picked up work on simplification and on reliance programs, including pilot programs in Brazil, Mexico, Malaysia, Singapore, Hong Kong, and China. Some further highlights:
- In the USA, we saw a ramp-up during the second half of the year, with guidance documentation being issued on PCCP for AI-enabled software functions, regulatory methods for assessing AI-enabled devices, production and quality system software, and more, in light of changing technology. Secondly, extensive preparations are underway for the introduction of the QMSR.
- Further in the Americas, we have seen Canada updating the MDEL system, among others, as part of the reform of foreign distribution licenses.
- In Europe, the key changes focus on simplifications in the system for medical device and IVD approvals, and on upgrading the governance system to MDR 2.0 and IVDR 2.0. The EU focus shifted from short- and long-term improvement to one single topic, improving cost-effectiveness, while all other programs and improvements have been delayed:
- Targeted revision of MDR, Commission draft scheduled for publication in Dec 25, after which negotiations will start with Council and Parliament.
- Implementing legislation on WET, notified body operations, and orphan devices expected to be published in Dec 25, with a limited transition window.
- Ad interim, the EU already published an implementing act allowing the wider use of electronic IFUs, and a new expert group was established on pediatric and rare disease devices. The report on the readiness of EUDAMED was published, and after extensive preparatory work, the system will officially go live in the course of 2026. Lastly, an evaluation was started to simplify rules on data, cybersecurity, and AI.
- For China, the NMPA issued a revision of the medical device GMP requirements. Furthermore, a series of standards was published, as well as a number of guidance papers, among others, on improvements for imported medical device production and on-site inspection of quality management systems.
- 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 on adding further chemical restrictions.
Preparing for 2026: Navigating Evolving Regulatory Challenges
Looking ahead into 2026, many of these changed expectations and refocused priorities will require regulatory effort and diligence.
With that in mind, we will continue to support a growing client base in both regulatory intelligence and in learning, capturing knowledge and know-how.
Qserve Learn is a state-of-the-art e-learning platform for regulatory, quality, and clinical professionals in the medical device and in vitro diagnostics (IVD) industry, already trusted by more than 900 users worldwide. Offering unmatched flexibility, Qserve Learn allows you to advance your skills at your own pace, anytime and anywhere. The platform currently hosts 40 e-learning courses, over 30 virtual training courses, 22 on-demand webinars, multiple training suites, and plans for the introduction of over 50 additional training courses in 2026.
Qserve Insight is 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, and impact assessments from Qserve’s seasoned professionals. With Qserve Insight, you stay ahead of regulatory changes and manage compliance in all global markets important to you. At this time, regulatory intelligence from 96 countries is streaming into the platform, alongside FDA, CEN CENELEC, and ISO standard databases, with further expansion foreseen for the year to come.
As the year draws to a close, we are already seeing both long-standing and new customers sharpen their priorities and set their course for 2026. We see a clear increase in requests for guidance on reliance programs and the best strategies to leverage existing approvals to accelerate market access for devices in other countries.
In parallel, demand for interim regulatory, clinical, and quality leadership and specialist support remains strong, particularly where manufacturers need to bridge capacity gaps due to departures, pending hires, maternity leave, or long-term illness. Finally, we see growing awareness among private equity and other investors that regulatory compliance, and specifically the robustness of clinical performance data, can be a deal-breaker during due diligence, driving the need for experienced experts to review documentation and data.
Wishing you a well-deserved break, meaningful moments with those close to you, and an energizing start to the new year. As we head into 2026, our global team stands ready to help you move faster and with confidence, wherever your priorities take you. We look forward to continuing our cooperation.
Jan van Lochem, Gert Bos, and Martin de Bruin