VPH Society Statement: In Silico Evidence in the Revised MDR
VPH Society has submitted a statement to the European Parliament’s SANT Committee on the revised Medical Device Regulation (MDR), welcoming the explicit recognition of in silico evidence — computational modelling, simulation, and related New Approach Methodologies — throughout the proposed text, including within the clinical evidence package.
A precise, well-targeted change
The Society’s position is that this update corrects a long-standing gap in the current MDR, which treats modelling and simulation almost exclusively as non-clinical evidence. This has historically forced a difficult choice between running a full conventional clinical investigation or forgoing a credible, quantifiable source of evidence altogether. The revised proposal addresses this by recognising in silico evidence as a legitimate, assessable contributor across the device lifecycle — alongside, not instead of, clinical investigation, real-world data, and post-market surveillance.
This approach already has precedent: computational modelling has supported regulatory decisions on 7T MRI safety and MRI-conditional pacemaker leads, and the VICTRE in silico trial substituted for a conventional clinical study in evaluating digital breast tomosynthesis.
Addressing the safety question
The statement directly addresses concerns that admitting digital evidence into the clinical phase could weaken regulatory standards. It argues this is not the case, for two reasons: regulators retain full discretion over what evidence is sufficient for a given device, and computational evidence would be subject to the same credibility scrutiny already applied to non-clinical evidence today, through established standards such as ASME V&V 40.
Where the case is strongest
The statement highlights that the argument for in silico evidence is sharpest for orphan and rare-disease devices, paediatric populations, and breakthrough technologies — areas where conventional trial evidence is hardest, or most ethically difficult, to obtain.
A community ready to contribute
VPH Society points to a decade of regulatory science groundwork already built by the in silico medicine community, including active contributions to international standards (ASME V&V 40, ISO/TC 194, IEC/TC 62, ISO/TC 276) and a track record of EU-funded projects that have moved these methods from research tools to regulatory-grade evidence sources. Having recently joined the MDCG New Technology Task Force, VPH Society states its readiness to support the Commission and Member State experts in translating this legislative recognition into practical guidance.
The statement closes with a set of specific recommendations for the SANT Committee on provisions to retain as drafted, and an offer to brief Members or staff on any amendment touching in silico or computational evidence.