VPHi submits MDR Revision Proposals to the European Commission

On 21 March 2025, we formally submitted our proposals for the revision of the Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) to the European Commission.

As an international scientific society representing the professionals from academia, research institutes, hospitals and health technology assessment bodies with expertise in in silico medicine, we support the European Commission’s consultation on the evaluation of Medical Device Regulation (MDR). Briefly our observations and submissions include:

• Limit disparities amongst evidence bases: in practice, the implementation organisations (Medical Device Coordination groups, Notified bodies), (inadvertently) limit the medical device assessment based on CM&S evidence, as non-clinical data for use in preclinical phase.
• Address the dilemma of quantifying uncertainties: we as a scientific community seek to clarify that traditional evidence sources (including animal and clinical data) are accepted, as they have a long history of use and “real-world testing”. Conversely, uncertainties of traditional evidence are even difficult to quantify and map with clinical endpoints or population level outcomes, objectively.
• Evaluate impeding MDR clause and MDCG guidance: restricting CM&S evidence to the preclinical phase, based on the MDR's reference to ‘computer models’ in MDR Annex VII 4.5.4(e), undermines the full leverage of in silico technologies to de-risk medical device experimentation in humans. This considerations has further been propagated to the MDCG guidance MDCG -2024-10.
• Emerging needs – digital twins in healthcare: consider the EC’s vision and policy initiatives to foster digital twins in healthcare through the European Virtual Human Twin initiative. It is imperative that the MDR remains relevant to these new technologies. Crucially, ensure MDR evaluation sets the direction to transform the current stagnation of regulatory pathways. Only then can publicly funded European innovation reach patients, which, in turn would enhance the competitiveness of the EU healthcare sector.

We assert that emerging computer modelling and simulation (CM&S) technologies, including artificial intelligence (AI), are ideally positioned to address the pressing challenges and concerns surrounding device safety and the increasing costs that impact the availability of novel treatments to wider segments of the European population. As an academic not-for-profit scientific society with active engagement with other professional societies, such as the Avicenna Alliance, the European Patient’s Forum etc., we share the learnings from EC-funded policy initiatives and our members' views, along with tangible scientific evidence demonstrating how these in silico medicine technologies can be leveraged.

Overall, crucial elements in the successful deployment and uptake of in silico medicine technology lies in its comprehensive inclusion in the MDR (extending beyond its currently assigned role in preclinical evidence generation). We need innovative medical products, and one effective way to achieve this is more “intelligent” pathways for regulatory derisking of medical products and more personalised provision of care. So there is no time to waste, we need the type of innovation in silico methodologies promises today, not tomorrow. Our learned academic colleagues look forward to share our academic stakeholder-informed insight and learnings from numerous EC-funded policy initiatives, Research & Innovation projects, ecosystem activities, CSA actions and peer-reviewed scientific evidence, and stand ready to leverage CM&S technology as an enabler to mitigate the overarching challenges addressed in this MDR evaluation process.

For more details download our submitted proposal