The EU Medical Device Shake-Up: What International Companies Should Prepare For

The European Commission has introduced major proposals to amend the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) to address critical implementation challenges and supply chain risks. These reforms aim to streamline regulatory processes and reduce administrative burdens by shifting toward a more proportionate, risk-based system. For the medical device sector, these changes are vital for maintaining market access and ensuring that innovative technologies reach patients without the delays caused by previous regulatory backlogs.

On December 16, 2025, the European Commission published formal proposals to amend the MDR and IVDR, marking a significant shift in the EU healthcare and MedTech landscape. These proposals are designed to overhaul current requirements to enhance predictability and support timely access to critical technologies while maintaining public health standards. The move follows a targeted evaluation and a call for evidence launched in late 2024 and 2025, which identified that the absence of grandfathering for legacy devices and limited notified body capacity were stifling innovation. A public feedback period on these new proposals is currently active from January 7, 2026, through March 5, 2026, before the text moves to the European Parliament and Council for final negotiations.

To address long-standing issues with notified bodies, the Commission introduced a draft Implementing Regulation on December 12, 2025, aimed at standardizing quality management and procedural protocols. The regulation proposes strict EU-wide maximum timelines, including 30 days for application reviews, 120 days for QMS audits, 90 days for product verification, and 15 days for certificate issuance. It also requires notified bodies to provide detailed cost breakdowns and justifications for price increases to eliminate opaque pricing structures. While these measures are intended to improve budgeting and planning for manufacturers, notified bodies are currently pushing back against the proposed timelines, suggesting potential friction before the rules are finalized in 2026.

Significant progress has also been made regarding EUDAMED, the EU’s centralized medical device database. On November 27, 2025, the Commission announced that four critical modules are now fully functional, triggering a six-month transition period for mandatory use. Starting May 28, 2026, manufacturers, importers, authorized representatives, and national authorities must comply with various transparency obligations under the MDR and IVDR. For non-EU manufacturers, this necessitates immediate action to ensure registration in EUDAMED and compliance with EU-specific labeling and language requirements to avoid missing market opportunities or facing regulatory enforcement.