Medtech leaders from across Europe and beyond have gathered in Galway this week for a major international conference calling for regulatory reform to protect patients, support innovation and strengthen Europe’s competitiveness in the global medical technology sector.
Global Access 2026, organised by Irish Medtech, the Ibec group representing the sector, is taking place at The Galmont Hotel in Galway on until this evening. The conference brings together 300 delegates and 60 speakers and is an associated event of Ireland’s 2026 Presidency of the Council of the European Union.
The two-day event examines the future of European medtech regulation, including clinical investigations, access to the US market, digital health, environmental requirements and the challenges facing European competitiveness.
Irish Medtech has warned that Europe’s share of the global medical technology market has fallen from 28% to 25.6% over the past decade, while the US share has increased from 40% to 46.4%.
The organisation said reform of the EU’s Medical Device Regulation (MDR ) and In Vitro Diagnostic Medical Devices Regulation (IVDR ) is critical to maintaining patient access to medical technologies while creating a more supportive environment for research, development and commercial growth.
Irish Medtech director Eoghan Ó Faoláin said the international regulatory landscape was undergoing significant change, driven by advances in technologies such as artificial intelligence, the emergence of new markets and evolving patient needs.
“The European medtech sector is renowned for its constant innovation, with over 15,905 patent applications filed with the European Patent Office in 2025,” he said.
However, he noted that recent years had seen lower volumes of medtech patent applications compared with areas such as computer technology, digital communications and electrical machinery.
While acknowledging advances across those sectors, Mr Ó Faoláin said the trend also highlighted the consequences of EU medical device regulations, which he said had introduced complexity and uncertainty for businesses operating in Europe.
He said the conference provided an opportunity for industry leaders, regulatory bodies and the European Commission to discuss reforms that would protect patients while fostering innovation and stimulating growth among businesses of all sizes.
Irish Medtech senior executive Dr Emer Sherry said Europe’s medical technology sector comprised approximately 38,000 companies, 90% of which were small and medium-sized enterprises, and employed around 800,000 people.
She described the European Commission’s proposals to reform the MDR and IVDR as a critical step towards improving patient access, supporting innovation and restoring the region’s competitiveness.
“We support the proposal’s ambition and warn against dilution which risks missing a long overdue opportunity to address the structural challenges,” she said.
Dr Sherry said Ireland’s position as a global medtech hub placed it in a strong position to help advance negotiations during its EU Council Presidency.
She said the Presidency presented an opportunity to build consensus and ensure Europe delivered a regulatory framework that was fit for purpose.
The conference features a range of international and national speakers, including Minister of State Hildegarde Naughton TD and European Commissioner for Health and Animal Welfare Olivér Várhelyi.
Other speakers include Roz Burke, senior vice-president of global quality and regulatory affairs at Boston Scientific; Roland Black, director of regulatory affairs for EMEA at Abbott; Dr Lucia Prihodova of the National Office for Research Ethics Committees; Paul Devereux, senior engineering director for surgical operations in Ireland at Medtronic; and Dhanashree Gokhale, digital health lead at the Health Products Regulatory Authority.
Discussions are expected to focus on how regulation can keep pace with technological developments while maintaining high standards of patient safety and ensuring medical devices can reach patients efficiently.
The event comes at a significant time for Ireland’s medtech industry, with the country playing a prominent role in the European medical technology sector and the Irish Presidency providing an opportunity to influence the direction of EU policy.
For Irish Medtech, the challenge is to ensure that reforms strike the right balance between patient protection and a regulatory environment that allows companies to develop and bring new technologies to market.
Global Access 2026 continues at The Galmont today Thursday, October 21 and 22.
