Chris Whitehouse, a political consultant and expert on medical technology policy and regulation at Whitehouse Communications, and advisor to MedTech suppliers, looks at a new consultation on the future of MedTech regulation in Europe.
The European Commission has launched a consultation seeking feedback from stakeholders across the medical technology sector to inform a targeted revision of EU rules for medical devices and in vitro diagnostics.
This initiative responds to challenges in implementing the Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR), which have led to concerns over device shortages, regulatory complexity, and market competitiveness. The Commission aims to simplify the framework while maintaining high standards of patient safety and public health.
The consultation invites input on proposed changes including reduced administrative burdens, more proportionate conformity assessments for low- and medium-risk devices, improved certification timelines, and greater alignment with international standards. These reforms are intended to support innovation, accelerate market access, and enhance the EU’s global competitiveness.
The MedTech sector is strongly encouraged to engage. The outcome of this consultation could significantly influence the future regulatory landscape. For manufacturers, especially SMEs, the proposed changes may reduce compliance costs and improve access to both EU and global markets. For patients, they could support broader availability of safe, innovative technologies.
The Commission will not conduct a full impact assessment, making stakeholder input during this phase especially critical. Feedback will inform a legislative proposal accompanied by an analytical staff working document.
Interested stakeholders – including manufacturers, clinicians, notified bodies, and patient groups – are invited to submit their views by 11:59pm CEST on Sunday, 6th October 2025 via the European Commission’s ‘Have Your Say’ portal.
With the clock ticking towards the October deadline, now is the time for MedTech businesses to speak up and help build a regulatory system that is fit for purpose, future-proof, and focused on delivering better outcomes for patients across Europe.
The Author used AI in preparing this article, comments upon or questions about which can be addressed to chris.whitehouse@whitehousecomms.com.
