Europe Targets Revised MDR and IVDR Adoption in Q2-Q3 2027

By Annette van Raamsdonk

The draft proposals for the revision of the Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR), published at the end of 2025, generated discussion. Competent authorities (CAs) and notified bodies (NBs) are concerned that measures to ease requirements could negatively affect the safety, performance and quality of devices. Some industry stakeholders welcome the proposed changes, while those who have already transitioned to the MDR or IVDR are concerned about unequal competitive conditions. Healthcare institutions welcome the loosened requirements for in-house manufacturers under Article 5.5 MDR/IVDR, which has raised concern within the industry that healthcare institutions may compete more directly with commercial manufacturers. 

As a result, discussions have extended beyond individual stakeholder groups and into broader political debates among EU member states, each bringing its own priorities and policy objectives to the negotiations. Despite these differing views, there is a clear interest in advancing the legislative process. The Health Products Regulatory Authority (HPRA), Ireland’s regulator, appears committed to supporting progress during Ireland’s presidency of the Council of the European Union through the end of 2026.

In recent weeks, Emergo by UL has attended several meetings that included representatives of NBs and CAs, as well as the European Commission (EC). These discussions provided insight into the current status of the revision process and the likely next steps.

Looking ahead

Progress continues on several legislative fronts. In September, the Committee on the Internal Market and Consumer Protection (IMCO) and the Committee on Budgets (BUDG) voted positively on the proposals. The CAs also discussed the proposals during the Competent Authorities for Medical Devices (CAMD) meeting in Dublin.

The next step is a European Parliament (EP) vote in Q1 2027, followed by trilogues in which the EP, the EU Council and the EC will work toward a provisional agreement acceptable to the co-legislators. Depending on the outcome of the trilogues, the following may occur:

1. The parties may reach a compromise, and changes to the proposals may be needed before adoption and publication in the Official Journal of the European Union (OJEU).

2. The proposals may be formally adopted as law by all parties and published in the OJEU.

3. No agreement may be reached, and the proposals may need to be reconsidered, requiring the legislative process to restart.

A compromise is expected, leading to adoption of the agreed text during the summer of 2027. Following adoption, the legislation will be published in the OJEU, with a transition period before the official date of application (DoA). 

Conclusion 

While the EU is targeting adoption of the revised MDR and IVDR by mid-2027, several key issues remain under discussion. NBs and CAs have expressed concerns that some proposed changes could, collectively, impact the safety, performance and quality of medical devices and IVDs on the EU market. Despite these concerns, regulators and stakeholders broadly agree that revisions to the regulations are necessary.

For manufacturers, the key message remains unchanged: continue working toward compliance with the current MDR and IVDR requirements. Although revisions are expected, the existing regulations remain fully applicable, and the content and timing of any future changes cannot be guaranteed. Even if the revised legislation is adopted in 2027, the revised requirements will not immediately become applicable. 

Organizations that continue their MDR and IVDR transition efforts today are expected to be well positioned regardless of the final outcome of the revision. In the meantime, Emergo by UL will continue to monitor developments and provide updates as more details become available.