Medtech leaders gather in Galway calling for regulatory reform that protects patients and EU competitiveness – Irish Medtech
- 300 delegates and 60 speakers gather in Galway for Global Access 2026, the largest medtech conference of its kind.
- Irish Medtech warns of challenges facing European innovation as the EU’s share of the global medtech market falls to 25.6%
Irish Medtech, the Ibec group that represents the medtech sector, is bringing together international leaders in Galway this week for Global Access 2026, the largest medtech conference of its kind.
Taking place at the Galmont, Galway on the 21-22nd October, the conference will welcome 300 delegates and 60 speakers as an associated event of the Irish Presidency of the Council of the EU 2026. Discussions will explore issues such as future-proofing European competitiveness, access to the US market, clinical investigations, what digital health means for regulations, and environmental regulations.
Irish Medtech Director Eoghan Ó Faoláin said: “The international regulatory landscape is seeing tectonic shifts with advances in technology like AI, rising markets like Japan, and new business practices to reflect changing patient needs. That’s why Global Access is such an important event for medtech leaders in quality and regulatory affairs. The European medtech sector is renowned for its constant innovation with over 15,905 patent applications filed with the Europe Patent Office in 2025. Recent years have seen lower volumes of medtech patents when compared to computer technology, digital communications, and electrical machinery, signalling a change in R&D patterns. While this reflects advancements in these sectors it also points to the consequences of the EU Medical Device and IVD regulations which have introduced complexity and uncertainty in Europe. That is why we are pleased to be joined this week by the European Commission, regulatory bodies, alongside industry leaders, to ensure that the ongoing reform supports an environment that protects patients, fosters innovation, and stimulates growth in Europe across businesses both large and small.”
Irish Medtech Senior Executive Dr Emer Sherry said: “There are 38,000 medtech companies in Europe, of which 90% are SMEs, and 800,000 people are employed. In the past ten years the European market share has shrunk from 28% of the world market to 25.6% compared to the US which has grown from 40% to 46.4% in the same period. The Commission's proposal to reform the European Medical Device and IVD Regulations are a critical step forward for patient access, innovation, and European competitiveness. We support the proposal’s ambition and warn against dilution which risks missing a long overdue opportunity to address the structural challenges. Given Ireland's position as a global medtech hub, the Irish Presidency of EU Council is an opportunity to move negotiations forward, build consensus, and ensure Europe delivers a long-promised regulatory framework that’s fit for purpose.
Speakers include:
- Minister Hildegarde Naughton TD
- Olivér Várhelyi, EU Commissioner for Health and Animal Welfare at European Commission
- Roz Burke Senior Vice President, Global Quality and Regulatory, Boston Scientific
- Roland Black, Director Regulatory Affairs EMEA, Abbott
- Dr Lucia Prihodova, Programme Manager, National Office for Research Ethics Committees (NREC)
- Paul Devereux, Senior Engineering Director, Surgical Ireland, Medtronic
- Dhanashree Gokhale, Digital Health Lead, HPRA
We would like to thank our sponsors, PLATINUM: Stryker; GOLD SPONSORS: Abbott, Arthur Cox LLP, Boston Scientific, Medtronic, National Standards Authority of Ireland (NSAI), Trinzo; SILVER SPONSORS: Bausch + Lomb, BSI, Ledidi, Life Science Recruitment, Merit Medical Systems Inc, TÜV SÜD, Irish Medtech Skillnet and Veeva MedTech.
ENDS
Photography available from Conor McCabe by emailing info@conormccabe.ie or calling +353 85 705 7255.
Global Access is Ireland’s leading medical technology industry Quality Assurance and Regulatory Affairs Conference, hosted by Irish Medtech. The event brings together national QA/RA experts, policy makers, regulators and representatives of the global medical technology industry. Further info available on www.globalaccess.ie
