EU Reviews Medical Device Rules

The European Commission has launched a call for evidence to support the targeted revision of EU medical device (MDR) and in vitro diagnostic device (IVDR) regulations. This initiative aims to streamline regulatory processes, reduce administrative burdens, and ensure the continued availability of safe, innovative medical technologies across the EU.

🔍 Consultation Timeline

i. Call for Evidence Open: 8 September 2025
ii. Feedback Deadline: 6 October 2025 (midnight CET)
iii. Commission Adoption: Planned for Q4 2025

🎯 Objectives of the Legislative Initiative

The proposed revision addresses growing concerns about the complexity and unintended consequences of MDR and IVDR. Key objectives include:

• Simplifying regulatory requirements to improve clarity and reduce administrative overhead.
• Supporting innovation and competitiveness, especially among SMEs and academic developers.
• Ensuring timely access to safe and effective medical and diagnostic devices.
• Making safety requirements proportionate and cost-effective for all stakeholders.

The revision responds to feedback received since the implementation of Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR) in 2021 and 2022 respectively.

🗣️ Stakeholder Feedback Highlights

The European Commission received broad support for the revision, especially from key stakeholder groups:

• SMEs: Raised concerns about the UDI labeling requirements and ongoing costs related to EUDAMED database upkeep.
• Academic institutions: Supported the revision and called for more flexibility in laboratory-developed tests, especially under the IVDR framework.
• Industry representatives: Requested clearer, more streamlined implementation guidance, citing innovation bottlenecks and challenges to global competitiveness.

⚖️ Type of Legislative Act

The Commission is preparing a Proposal for a Regulation, grounded in findings from the implementation evaluations of MDR and IVDR. This regulation will serve as a targeted amendment to the existing frameworks rather than a full overhaul.

📌 Why This Matters

• Helps avoid medical device shortages caused by regulatory delays or notified body bottlenecks.
• Aligns with broader EU health priorities, including EU4Health, the European Health Data Space, and strategic healthcare resilience.
• Encourages a more agile regulatory environment that maintains patient safety while supporting rapid technological development.

📝 What’s Next?

• Stakeholder feedback will be analyzed and published on the Commission's portal.
• The legislative proposal is expected in Q4 2025.
• Industry stakeholders should prepare for potential changes to conformity assessments, notified body access, and data reporting.

Reference: Medical devices and in vitro diagnostics – targeted revision of EU rules