Eugene Lennon

Intent: Secure reforms to EU MDR and IVDR to simplify the regulatory process to ensure patient access and improve competitiveness.

Details: EU Medical Device and IVD Regulations (MDR / IVDR)

Intent: On November 20 David Kelly, representing Global Heart Hub met with the Irish Permanent Representation to the EU. The meeting sought to influence the content of the upcoming EU Cardiovascular Health Plan, which was adopted by the European Commission in mid-December. At the meeting, GHH as part of the 'Cardiomyopathies Matter' collaboration stressed the urgent need for explicit reference to cardiomyopathies in the cardiovascular health plan, in order to promote early diagnosis and prevention. ::Policy asks included strengthening the language on the role of patients, better holistic support for patients and families (including psychological care), and improved education and awareness among healthcare professionals.

Details: Out Reach re EU Cardiovascular Health Plan

Intent: To inform and garner greater support for urgent reform of the EU Medtech Regulations, highlighting it's impact on multinationals and indigenous start up medtech companies

Details: Impact of European Medical Technologies Regulations (MDR): Multi-nationals and Indigenous start ups

Intent: Appeal to Irish Government to support the exclusion of medical technologies (and inputs to medical technology products) from any reciprocal EU tariffs.

Details: Retaliatory Tariffs: Impact on healthcare in Europe

Intent: Advocate for urgent action on the EU Medical Device Regulation (MDR) at the European Council Employment, Social Policy, Health and Consumer Affairs Council (EPSCO) meeting and request to establish a National MDR/In Vitro Medical Devices Regulation Consultative Forum in Ireland.

Details: National Consultative Forum on Regulations

Intent: Ensure EHDS coherence with Medical Device Regulation (MDR), need for clear definitions, protection of IP and data transfers

Details: European Health Data Space