EU Commission publishes promised proposed updates to MDR and IVDR

On 16 December 2025, the EU Commission published its ‘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.’

In introducing the proposal, the Commission states that it “aims to streamline and future-proof the regulatory framework. Its main objective is to simplify the applicable rules, reduce the administrative burden on manufacturers and enhance the predictability and cost-efficiency of the certification procedure by notified bodies, while preserving a high level of public health protection and patient safety, and thus to help achieve the initial objectives of the Regulations.”

Continuing by explaining that “A new regulation is needed to remedy the problems that have been identified, which otherwise would have a considerable impact on the medical devices market and, consequently, on the quality of healthcare provided to patients in the EU.”

The proposal has resulted, in part, from completion of the Commission’s ‘targeted evaluation of the Regulations’, which concluded that while device safety and performance had been strengthened by the MDR and IVDR, this came “at high and often disproportionate compliance costs, caused also by high regulatory complexity”, concluding that “there is a potential to simplify and to reduce burden relating to the implementation of both Regulations, without undermining their main objectives.”

The revised text includes may changes, deletions and inclusions, too numerous to even summarise in this news item, so readers are recommended to download a copy to review and determine how the changes might affect each specific situation.

The proposal has now been sent to the European Parliament and the Council of the European Union. It must be confirmed by both co-legislators under the ordinary legislative procedure before it can become law. During this phase, both institutions will review the text and changes are still possible. Representatives from the Commission, Parliament, and Council will then meet (‘trilogue negotiations’) to reach a common agreement on the final text.

Timeline estimates are:
Mid-2026: Expected commencement of trilogue negotiations.
Mid- to Late-2026: Potential final adoption by the Parliament and Council.
2027–2028: Forecasted gradual entry into force of the new regulatory changes

In addition, the Commission published on the same day a Draft Implementing Regulation, laying down rules for applying the requirements to be met by notified bodies, specifically by making significant revisions to Annex VII of the MDR and IVDR. The draft is subject to a public feedback period ending on 23 January 2026.