Analysis of the European Commission’s proposal for the revision of the MDR and IVDR
£69.00
A legal analysis of the European Commission proposal and its impact on certification and clinical strategy
English
Abstract:
On 16 December 2025, the European Commission published a legislative proposal to amend Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). The proposal responds to persistent implementation challenges – including capacity constraints in the Notified Body system, disproportionate compliance burdens on manufacturers, and perceived barriers to innovation and competitiveness – identified through a targeted evaluation and extensive stakeholder consultation. The initiative’s stated objectives are to simplify applicable rules, reduce administrative burden, enhance the predictability and cost efficiency of certification, and future-proof the European Union (EU) regulatory framework, while preserving a high level of public health protection and patient safety. It addresses, among other topics, conformity assessment procedures, Notified Body oversight, product qualification and classification, clinical and performance evaluation, digitalisation, the role of the European Medicines Agency, supply chain obligations, software and artificial intelligence, as well as pathways for orphan and breakthrough devices. This article by Vladimir Murovec provides a general legal and regulatory analysis of some of the key proposed amendments, situating them within the broader EU policy context and drawing on the primary legislative text, accompanying documentation and implementing legislation.
Learning objectives:
The article will help readers:
- Understand the direction of travel across the key proposed changes: conformity assessment procedures, Notified Body governance and fees, product qualification and classification, clinical and performance evaluation, digitalisation, the European Medicines Agency’s expanded role, supply chain obligations, software and AI regulation, and new pathways for breakthrough and orphan devices.
- Identify which proposals are most likely to affect your day-to-day work: from certification planning and classification decisions to clinical evidence strategies and the regulatory treatment of AI-based devices.
- Recognise where legal uncertainty remains and where it is premature to adjust operational decisions before the legislative process concludes.
About the author:
Vladimir Murovec is a Counsel at Osborne Clarke in Brussels, Belgium, specialising in EU regulatory and compliance law in the life sciences sector, with a particular focus on medical devices, in vitro diagnostics and pharmaceuticals. He advises manufacturers, distributors, investors and other stakeholders on the EU medical technology, pharmaceutical, health AI and digital health legislation. Vladimir is an Associate Editor of the European Health and Pharmaceutical Law Review and a regular contributor to peer-reviewed legal and regulatory journals.
Specification:
18 pages plus covers, in English, supplied by email as a PDF.
This article has been published in the May 2026 issue of the Journal of Medical Device Regulation.
