Virtual Physiological Human Institute
VPHi
Our vision is to ensure that in silico medicine is fully realised, universally adopted, and effectively used both in research and clinic.
ID: 575677897412-34
Lobbying Activity
Response to Targeted revision of the EU rules for medical devices and in vitro diagnostics
6 Oct 2025
Subject: Leveraging computer modelling and simulation methodologies including AI, to mitigate current challenges and prepare for future needs. The VPH Institute (VPHi), an international scientific society representing experts in in silico medicine (use of computer modelling and simulation in health and care) from academia, research institutes, hospitals, and health technology assessment bodies, supports the European Commissions consultation on the evidence for revision of the Medical Device Regulation (MDR). While the challenges inherent in the regulatory landscape of medical devices are widely discussed by many contributors from industry, clinical societies, SMEs, NGOs, etc., VPHi asserts that emerging Computer Modelling and Simulation (CM&S) technologies, including Artificial Intelligence (AI), are ideally positioned to address the pressing concerns surrounding evidence generation for pre-market and post-market phases. It can address concerns on device safety and the increasing costs that impact the availability of novel treatments for the European population. As a non-profit scientific society, VPHi draws upon and shares the learnings from EC-funded policy initiatives, such as FP7, Horizon, and Digital Europe calls, along with tangible scientific evidence demonstrating how these in silico medicine technologies can be can be an enabling paradigm across the entire lifecycle of medical devices, from ideation and design to deployment and post-market surveillance. We here present the evidence to leverage CM&S as a necessary enabler to address current bottlenecks and to act as an engine for competitiveness across the European healthcare sector. We here present 6 areas for attention, with suitable solution and evidence: i. A failure to recognize and address gaps in conventional clinical trials through emerging digital technologies like computer modelling and AI, leading to regulatory and adoption delays ii. Impeding MDR clause and MDCG guidance on evidence from computer modelling and simulation testing iii. Lack of unified authority, as well as qualified regulatory science tools / methodology for medical devices iv. Latency in development and recognition of standards for regulatory and common specifications for MDR/IVDR compliance v. Lack of channels for engagement with early innovators (e.g. academia, scientific consortium) vi. Safety and Ethics in Human Testing Concern on safety and ethical aspects around responsible human testing Yours sincerely, Prof. Dr. Liesbet Geris, Executive Director VPH Institute; University of Liège, KU Leuven, Belgium.
Read full responseResponse to Biotech Act
11 Jun 2025
The VPH Institute welcomes European Commissions determined efforts to accelerate biotech products, while seeking solutions to address safety and protections. 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 Commissions efforts to support the needs of and provide solutions for the biotech sector. The Virtual Physiological Human scientific communitys vision and mission is to `act as a catalyst to bring together a variety of stakeholders to benefit from the use of digital technologies, to deliver the best possible treatment to patients and to drastically improve healthcare. Our Contribution to the Biotech Act: Key Focus Areas Driven by our shared vision, we are committed to actively contribute to the following crucial areas within the Biotech Act's 'Call for Evidence': 1. Accelerating biotech innovations in the health sector through the strategic application of digital technologies, including Artificial Intelligence and computational modelling. Our aim is to de-risk design, development, manufacturing, clinical trials on biopharmaceutical products, thereby maximizing the impact of biotechnology advancements. 2. Reducing regulatory uncertainty within the biopharmaceutical domain of the biotech sector. We propose achieving this through enhanced standardization and advancements in regulatory science, specifically by complementing traditional evidence with robust digital evidence derived from computational models. 3. Optimizing the utilization of public infrastructures for data, models, and computing resources. Here, we seek to harness and align with the European Commission's flagship program for Virtual Human Twins. We have provided further elaboration in the attached document.
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