The European Commission officially closed its public consultation on the Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) on 21st March 2025. This targeted evaluation invited feedback from stakeholders across the diagnostics industry to assess how well the regulations are working and where they may be falling short.
The consultation focused on five key areas: effectiveness, efficiency, relevance, coherence, and EU added value. Stakeholders were asked to reflect on how the rules have affected innovation, the availability of devices (especially niche or legacy products), and the challenges faced by smaller organizations in meeting compliance costs and documentation requirements.
Responses will feed into the Commission’s broader evaluation of the regulations, which aims to ensure that safety, reliability, and innovation remain balanced under the evolving framework. This includes understanding whether the current rules help or hinder timely access to safe and effective diagnostics — a key theme explored in our latest white paper, Navigating the IVDR: Challenges, Opportunities, and a Path to Safer Diagnostics.
Like the consultation, our report reflects a shared concern among manufacturers, laboratories, and policymakers. While the IVDR strengthens safety and oversight, it has also introduced bottlenecks, cost burdens, and uncertainty that risk limiting innovation and diagnostic access, especially for SMEs. The consultation offers a chance to influence what comes next, including potential amendments or guidance to bring greater clarity and flexibility to IVDR implementation.
For more information on the initiative and to stay updated on the evaluation’s progress, please visit the European Commission’s ‘Have Your Say’ portal.