MDR/IVDR Reform Proposal: Open Feedback Period 7 January 2026 – 4 March 2026
7 January 2026
18 New EU MDR/IVDR Harmonized Standards & UK Designated Standards
30 January 2026Reading time: 1 minute
Background
On 16 December 2025, the Commission published COM(2025)1023, a proposal to reform the MDR/IVDR. It includes significant and sweeping changes. The proposal has been submitted to the European Parliament and the Council of the European Union.
On 7 January 2026, the Commission opened a public consultation on its proposal, available until 4 March 2026.
Marked-up Regulation Text
The Commission published documents that integrate all of the proposed changes directly into the MDR and IVDR: HERE
These are non-official working documents, provided simply to more easily see which Articles and Annexes of the regulation have been impacted.
WTO Publication
The proposal was published to the World Trade Organization (WTO) website today: HERE
WTO publications act as trade transparency, alerting the other 164 WTO member countries of a government’s intent to make a change, and creates an international record of concerns/support for initiatives. The EU is legally obligated under the WTO Technical Barriers to Trade (TBT) Agreement to notify technical regulations that could affect trade.
Interested parties have until 19 April 2026 to provide feedback through the WTO notification process.
Per the notification, the Commission aims for adoption in 2026, with a proposed date of entry 20 days after its publication in the Official Journal of the European Union.
Casus will continue to closely track progress.
