On 10 March, 2026, VPH attended the study day hosted by the Belgian Federal Agency for Medicines and Health Products (FAMHP) focused on the evolving landscape of in-house medical device software. As advanced digital care solutions become increasingly integrated into clinical practice, staying aligned with the latest regulatory frameworks is a top priority for the scientific community, such as that of VPH. As early innovators working in close partnership with clinical centers, in silico technology developers must ensure that the disruptive medical technologies they co-develop with healthcare professionals meet the compliance and liability obligations of healthcare institutions.
The event, held on March 10, 2026, brought together leading voices from university hospitals, medical centers, industry, notified bodies, and regulatory authorities to dissect the complexities of the Medical Device Regulation (MDR), as well as dive deep into the nuances of in-house medical device software.
Key Highlights from the Session:
- Qualification & classification: Koen Cobbaert (Philips) provided a deep dive into how medical device software is categorised under current rules—a critical step in determining the level of oversight required.
- The regulatory landscape: Stef Rommes (VITO) mapped out the broader European environment, ensuring a clear understanding of how local Belgian efforts fit into the EU-wide MDR framework.
- Certification pathways: Thomas Doerge from the notified body BSI outlined the rigorous CE certification process, while Benedicte Nuyttens (FAMHP) discussed the nuances of clinical investigations for medical device (software).
- The In-House Exemption: A standout session by Christophe Driesmans (FAMHP) explored the specific “in-house exemption” criteria, which allow healthcare institutions to develop and use their own software under strictly defined conditions.
What does this mean for VPH Society & our community?
Healthcare institutions serve as the initial testbeds for in silico-based clinical decision support systems, including rapidly emerging technologies like digital twins and AI solutions. The VPH Society continues to foster strong collaboration with healthcare professionals, as they are the primary end users who bring the benefits of in silico medicine to patients and citizens.
By engaging directly with Belgium’s national competent authorities and healthcare providers, we strengthen our critical insight into the current landscape of in-house medical devices. Attending these in-person sessions ensured that the VPH Society gathered first-hand insights on regulatory expectations and obligations, allowing us to familiarise the pathway to innovate, test and integrate early innovations within healthcare institutions. This is vital to ensuring our emerging in silico solutions are fully compliant and do not pose risks or liability.
Overall, the study day helped map various regulatory pathways and identify potential challenges, while spotlighting a clear call to action for all stakeholders.
Event recording in English and PPT available here