Medical devices: Simplifying the rules [EU Legislation in Progress]

Written by Laurence Amand-Eeckhout.

CONTEXT

On 16 December 2025, the European Commission put forward a proposal for a regulation to simplify the rules governing medical devices in the EU. The proposal forms part of a broader package of measures aimed at improving citizens’ health and strengthening the resilience and competitiveness of the health sector. An evaluation of the current EU regulatory framework for medical devices concluded that it has led to unnecessary costs, administrative bottlenecks, regulatory uncertainty for companies, and delays in patient access to medical devices. The proposed revision seeks to address these challenges while ensuring that patient safety remains the highest priority, with faster access to safe and innovative devices. It also aims to reinforce the EU’s competitiveness in the medical technology sector, by establishing a more coherent framework enabling companies to better respond to evolving market conditions, technological developments and patient needs.

LEGISLATIVE PROPOSAL

2025/0404(COD) – Proposal for a regulation of the European Parliament and of the Council amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards simplifying and reducing the burden of the rules on medical devices and in vitro diagnostic medical devices, and amending Regulation (EU) 2022/123 as regards the support of the European Medicines Agency for the expert panels on medical devices and Regulation (EU) 2024/1689 as regards the list of Union harmonisation legislation referred to in its Annex I – COM(2025) 1023, 16 December 2025.

NEXT STEPS IN THE EUROPEAN PARLIAMENT

For the latest developments in this legislative procedure, see the Legislative Train Schedule: 2025/0404(COD)

Read the complete briefing on ‘Medical devices: Simplifying the rules‘ in the Think Tank pages of the European Parliament.