EU MDR and IVDR Regulatory Watch: March 2025

This update focuses on the operational readiness manufacturers need for the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). The priority is not a single filing event, but maintaining evidence, data, and surveillance records that can support the product throughout its life cycle.

What to review

• Technical documentation, including device description, GSPR evidence, risk management, and clinical or performance evaluation.
• EUDAMED-related master data and the internal owner for actor, device, certificate, and vigilance information.
• Post-market surveillance procedures, periodic reports, and the route for serious incident assessment.

Practical impact

Manufacturers with legacy certificates or transition plans should maintain a dated matrix of product, certificate, notified body, and evidence status. IVD manufacturers should give particular attention to performance evaluation planning and scientific validity evidence.

Source to monitor

Follow the European Commission medical devices sector and the applicable notified body communications for current implementation notices.