A Watershed Moment for In Silico Medicine in the EU MDR Revision

While a detailed analysis of the nuances is underway, we are excited to see that the proposal echoes our long-standing calls to leverage validated in silico methodologies including but not limited to AI, to mitigate current regulatory challenges and prepare for future needs.

Key Highlights for the In Silico Medicine Community:

• A shift in the Regulatory Paradigm: this recognition reflects a growing awareness of the pivotal role validated silico approaches can play across the entire product life cycle in enhancing scientific validity, fostering innovation, derisking devices, and reducing costs, leading to increased patient safety and access.

• Clarity and Inclusion: for the first time within the EU MDR/IVDR framework, in silico modelling is consistently referenced. This explicit inclusion across different evidence sources provides the clarity needed to integrate digital evidence into the device lifecycle.

• Recognition of New Approach Methodologies (NAMs): the proposal acknowledges that a “wide range of data may qualify as clinical data.” By promoting proportionality and simplification, the revision explicitly encourages the use of validated in silico testing to support regulatory submissions.

Moving Forward

This progress is a testament to the power of sustained, collective engagement between the European institutions, Member States, regulators, academia, industry, clinicians, and patient organisations. It demonstrates how a shared vision can translate regulatory ambition into concrete, legislative change.

We are grateful for the European Commission who did an enormous amount of work to bring the wide range of inputs together in a comprehensive revision and for our members at VPH, the EDITH partners, the Avicenna Alliance and UK CEiRSI and many others for constructive discussions and continued engagement.

We will continue to analyse the proposed regulation to assess its impact on the field and work with the EU parliament to provide scientific background, clarifications and suggestions.

Instrumental role for in silico in healthcare legislation

In an exceptionally busy week, the European Commission released several other proposals for acts, regulations, guidelines and plans. You can find all texts here and our comments on them in our LinkedIn posts. We will continue to analyse these texts and will organise 2 online meetings for our members to further discuss them.

• • Breakthrough guidance under current MDR
  • Revision MDR
  • Biotech Act
  • Cardiovascular plan