MedTech Europe

EU Legislative Interests

Healthcare, and Medical Technologies • Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices. • Regulation (EU) 2017/745 on Medical Devices. • Regulation 2021/2282 on Health Technology Assessment (HTA). • Pharmaceutical Strategy for Europe, including the revision of related legislative frameworks (e.g., orphan and paediatric medicinal products). • European Health Data Space Regulation. • Blood, tissues, and cells legislation. • Policies addressing Antimicrobial Resistance (AMR) and Healthcare-Associated Infections (HAIs) and non-communicable diseases (NCDs). • Directive on Cross-Border Health Care. • HERA Regulation (Health Emergency Preparedness and Response Authority). Digital Health, Innovation, and Cybersecurity • Artificial Intelligence Act. • Cyber Resilience Act. • Data Act. • Directive on measures for a high common level of cybersecurity across the Union (NIS Directive 2). • Policies supporting digital health innovation Environmental and Sustainability Legislation • The European Green Deal and its initiatives, including: -Chemicals Strategy for Sustainability. -Circular Economy Action Plan (e.g., Batteries Legislation, Packaging Waste Legislation). -REACH Regulation, RoHS Directive, and WEEE Directive. • Corporate Sustainability Reporting Directive. • Corporate Sustainability Due Diligence Directive. Industrial and Trade Policies • Critical Raw Materials Act. • Clean Industrial Deal and related policies (e.g., European Competitiveness Fund, Chemical Industry Package). • Single Market Strategy. • Bilateral and multilateral trade agreements, customs procedures, and resolution of technical barriers to trade. Liability and Consumer Protection • Product Liability Directive. • AI Liability Directive. • Representative Action Directive (Collective Redress). Other Frameworks • Regulation for a European Health Union. • Horizon Europe research initiatives, including those on medical countermeasures and biotech innovation. • Public Procurement Directive. • Late Payment Directive. • Omnibus Packages • Industrial Decarbonisation Accelerator act • Biotech Act • Life Sciences Strategy • Multiannual Financial Framework

Interests Represented

Promotes their own interests or the collective interests of their members

Member Of

*AMR One Health Network:EC led multistakeholder platform to deal with the cross-border health threat of AMR *AP4HE:an intersectoral initiative that brings together a diverse group of NGOs, think-tanks, associations, companies, and individuals *Data saves lives:A multi-stakeholder initiative with the aim of raising wider patient and public awareness about the importance of health data *EFLM: it connects National Societies of Clinical Chemistry and Laboratory Medicine and creates a platform for all European “Specialists in Laboratory Medicine *ESAE: The leading European organisation bringing together Association professionals *European Internet Forum: MEP-led network of digital policy stakeholders and a neutral, transparent and non-partisan platform to better understand the Internet and its foreseeable impact on Europe's economy, society and governance *European Policy Center:an independent, not-for-profit think tank dedicated to fostering European integration through analysis and debate *EU Health Coalition: A multi-stakeholder initiative dedicated to driving change for a healthier Europe *Friends of Europe: A think tank that supports a multilateral world in which all levels of governance, the private and civil society sectors, as well as citizens, cooperate to solve common challenges *GMTA: The Global Medical Technology Alliance (GMTA) member associations represent companies that produce the medical devices, diagnostic products and health information systems that are transforming health care through earlier disease detection, less invasive procedures and more effective treatments. Our represented companies produce nearly 85 percent of the health care technology purchased and utilized annually around the world. *HTA Stakeholder Network: Stakeholder organisations with an interest in Union cooperation on HTA, including patient associations, consumer organisations, health technology developer associations, health professional organisations and other relevant non-governmental organisations in the field of health, including clinical and learned societies.

Organisation Members

Please see on: https://www.medtecheurope.org/about-us/members/

Additional Information

Our cost is estimated @1.5 million. It accounts for: * the staff cost (a prorata 12.5% or 25%) of the 16 FTE involved. * the admin cost linked to those 16 FTE * the operational expenses * the outsourced activities (consultants) e.g. HLC, FTI, Edelman, ...