European Parliament advances MDR/IVDR revision: critical implications for In Silico & Digital Health Technologies
As the European Union moves forward with revising Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR), the European Parliament’s Committee on Environment, Public Health and Food Safety (SANT) is taking a central role in recalibrating the MedTech regulatory landscape.
SANT rapporteur Oliver Schenk published a draft report containing more than 130 proposed amendments to the Commission’s legislative proposal. While Parliament broadly supports reducing regulatory friction, the proposed changes introduce key structural shifts—offering both welcomed streamlining and new regulatory hurdles for computational modelling, digital twin technologies, and software developers.
Key proposed amendments impacting the VPH community
- Coordination at National and European level on regulatory status (e.g. designation, classification) for pre-market and post-market devices
- Distinct enlisting of ‘orphan devices’, ‘breakthrough devices’, and a new group, referred to as “niche devices”
- The Draft Report attempts to simplify the software classification rules introduced by the Commission, but opened critical reflection from stakeholders.
- Use of IVD’s in clinical trials
- Clarity and broadened scope on structure dialogues alongside pre-submission consultations, throughout the conformity assessment procedure.
- And many more…
Following initial deliberations in the SANT Committee, political groups have submitted their proposed amendments to the draft report. Technical meetings and negotiations with shadow rapporteurs are now underway through the autumn, leading up to an expected plenary vote in early 2027 to establish the European Parliament’s position on the MDR revision.
Meanwhile, stakeholders across the sector are evaluating the draft, their amendments and voicing critical concerns. The VPH team is closely tracking these developments and will share our position and further updates in the coming weeks.
For further information, please see:
SANT Committee draft report with 130 amendment proposals: 1 July 2026
Amendments:
