On 16 December 2025, the European Commission published a legislative proposal to amend the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). The proposal forms part of the Commission’s targeted work to simplify and reduce the administrative burden of the current framework. It follows the findings of a two‑year evaluation and extensive feedback from Member States, industry stakeholders, competent authorities and the European Parliament.
What the proposal would change
The draft Regulation introduces several updates, divided in eight topics:
- Simplification and proportionality
- Reduction of administrative burden
- Innovation and availability of devices for special patient groups or situations
- Predictability and cost-efficiency of certification
- Coordination within the decentralised system
- Further digitalisation
- International cooperation
- Interplay with other Union legislation
Public consultation
The Commission is collecting public feedback through its Have Your Say platform. As of now, the consultation is open until March 2026. The consultation provides for an eight-weeks feedback period, which is being extended every day until this adopted proposal is available in all EU languages.
Any interested party may participate. This includes, among others, manufacturers, authorised representatives, notified bodies, competent authorities, health professionals, patients, and academic and regulatory experts.
What manufacturers should do next
Manufacturers should stay informed, monitor the legislative process, and consider contributing to the public consultation, so that practical implementation concerns are captured early in the discussion between EU institutions.
As your European Authorised Representative, Obelis is ready to help you navigate the upcoming changes.
Contact Obelis to discuss how this proposal may affect your business. Get in touch to get started!
References:
European Commission. (2025). Proposal for a regulation amending Regulations (EU) 2017/745 and 2017/746. COM(2025) 1023 final. Retrieved on 19/01/2026.
European Commission (2025). Medical devices and in vitro diagnostics – targeted revision of EU rules. Better Regulation Portal, European Commission. Retrieved on 19/01/2026.
MDlaw.eu. (2026). EU MDR and IVDR targeted revision consultation now open. Retrieved on 19/01/2026.
MDLaw.eu. (2025). Commission publishes a Proposal for a Regulation to simplify MDR and IVDR. Retrieved on 19/01/2026[SV1] .
Giulia Maria Trapanese
Regulatory Intelligence & Innovation Department
19/01/2026
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