Call for evidence on the targeted revision of EU MDR & IVDR

On 8 September 2025, the European Commission launched a Call for Evidence on the targeted revision of the EU rules for medical devices (MDR) and in vitro diagnostics (IVDR). The initiative is led by DG SANTE (Unit D3 – Medical Devices) and aims to simplify and streamline the current framework while preserving a high level of safety and public health.

This step follows the targeted evaluation carried out since 2024 and reflects growing calls from the European Parliament, Member States, and stakeholders to reduce administrative burdens and enhance predictability, especially for SMEs. The Commission plans to propose a legislative revision in Q4 2025.

Objectives of the public consultation

The initiative seeks to:

• reduce administrative burdens, including reporting obligations.
• enhance the predictability and cost-efficiency of notified body certification processes.
• make conformity assessment requirements more proportionate, particularly for low- and medium-risk devices.
• enable further digitalisation and streamline governance procedures.
• foster international cooperation and alignment with other EU legislation.

Implications of the EU MDR and IVDR revision

The implementation of the MDR and IVDR has faced challenges due to demanding requirements, limited notified body capacity, and insufficient manufacturer preparedness. These factors have led to risks of device shortages, delays in innovation, and potential competitiveness losses for the EU medical device sector.

The targeted revision aims to future-proof the regulatory framework, making it leaner and more cost-effective, while ensuring that patients continue to benefit from safe, innovative, and widely available medical devices.

How to participate to the EU MDR and IVDR revision

Stakeholders are invited to share their views. Contributions may be submitted in any of the 24 EU official languages here until 6 October 2025 (midnight Brussels time).

If you do not want to miss any regulatory updates regarding MDR or IVDR, contact MDlaw.eu here or at mdlaw@obelis.net.

References

European Commission (2025). Call for Evidence, Medical devices and in vitro diagnostics – targeted revision of EU rules. Retrieved on 09/09/2025.