Irish Medtech hails EU Commission’s revision proposal as "critical first step" for sustained patient access to health tech and innovation
Irish Medtech, the Ibec group representing the medical technology sector, has today welcomed the European Commission’s targeted revision proposal to the EU Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). The group views the proposal as a vital step toward reforming Europe’s regulatory landscape to ensure patients maintain access to life-saving treatments.
The proposed revisions arrive as the sector faces significant administrative hurdles and bottlenecks under current regulatory frameworks, which particularly impact SMEs and startups (80% of medtech companies in Ireland). The Commission’s proposal aims to streamline and simplify these processes within the EU regulatory system.
Dr. Emer Sherry, Senior Executive at Irish Medtech, praised the speed and scope of the Commission’s response:
“We acknowledge the significant efforts by the EU Commission in bringing forward this comprehensive proposal so quickly. The inclusion of pathways for breakthrough innovations and orphan devices, alongside the extension of certificate validity and scope for increased digitalization, marks a positive shift toward greater efficiency in the system. The timing of this proposal is particularly significant as Ireland prepares to assume the Presidency of the EU Council in July 2025. Given Ireland’s status as a global leader in medical technology, the country is uniquely positioned to spearhead these critical legislative discussions.
However, it is important to note that this is just the beginning and further stakeholder dialogue is required. We believe the proposal does not sufficiently address governance concerns. The industry believes a single, future-proofed, accountable governance structure is required to champion medtech at the EU level, ensure the regulatory system keeps pace with the rapid evolution of medical technologies, and allow for greater international cooperation.”
Eoghan Ó Faoláin, Director of Irish Medtech, emphasized the economic and clinical stakes: “For Ireland to remain a global medtech hub, we must have regulations that work for patients and healthcare innovators alike. This proposal offers a critical opportunity to restore Ireland and the EU as the premier global locations to launch new medical devices. We now look to the EU Parliament and Council to ensure this proposal delivers on the ambition of increasing European competitiveness and fostering true innovation.”
