MedTech Europe

MedTech Europe envisions a future where healthcare systems are environmentally and financially sustainable, equitable and resilient to future crises. Building such resilient and sustainable healthcare systems requires a robust, competitive, and innovation-driven medical technology industry.

Evaluation & contract award criteria Relying on price as the main or sole award criterion in healthcare procurement undermines medtech value, patient outcomes, efficiency and healthcare costs Solution Prohibit price-only contract awards to safeguard competition and innovation Price-only should be used only in exceptional cases with clear justification Mandate bid assessment based on balanced evaluation and contract…

MedTech Europe welcomes the opportunity to provide feedback to the European Commissions proposal around the targeted reform of EU rules on medical devices (MD) and in vitro diagnostic medical devices (IVD). Europes regulatory framework for medical technologies is at a decisive moment.

MedTech Europe welcomes legislative reform, provided it delivers a regulatory system that enhances competitiveness, is efficient, lean and fit for purpose, supports innovation, is well-governed and ensures patients access to devices. Short-term relief measures are needed in parallel to the reform (e.g.

MedTech Europe calls for a revised Public Procurement Directive that shifts from price-only to value-based, outcome-focused procurement, using BPQR by default, early market dialogue and simplified, harmonised implementation across EU. Healthcare requires tailored rules reflecting innovation cycles and patient impact.

MedTech Europe, the European association of medical technology manufacturers, including medical devices, diagnostics and digital health, welcomes the possibility to comment on the draft delegated regulation amending Delegated Regulation (EU) 2023/2486 as regards enhancing the usability of the technical screening criteria. We acknowledge the efforts of the European Commission to simplify the taxonomy.

MedTech Europe - the European trade association for the medical technology industry including diagnostics, medical devices and digital health - welcomes the opportunity to contribute to the initial roadmap consultation regarding the legislative proposal for substantiating green claims.

MedTech Europe welcomes the opportunity to provide feedback on the published proposal for a Biotech Act I, which aims to strengthen the EU health biotechnology ecosystem, support innovation, and enhance Europes competitiveness. Medical technologies play a central role in Europes biotechnology landscape.

Biotechnology plays a significant role in the development of medical devices and in vitro diagnostics (IVDs). For medical devices, this includes implantable devices and bioprinting. For IVDs, biotechnologies are crucial for genetic testing, encompassing molecular diagnostics for both infectious and non-infectious diseases, as well as Next Genome Sequencing.

MedTech Europe welcomes the opportunity to provide feedback on the Proposal for a revised Cybersecurity Act, which seeks to strengthen the EUs cybersecurity capabilities and resilience while preventing fragmentation across the Digital Single Market.

Global carbon pricing next to boosting more renewable energies and energy efficiency is key for combating climate change. It levels the playing field, rewards innovation and drives emission reductions cost effectively. MedTech Europe shares the general motivation of preventing carbon leakage in support of fair carbon pricing as long as global climate ambitions differ.

MedTech Europe welcomes the European Commissions initiative to develop a European Innovation Act to promote and accelerate the deployment and diffusion of technology of today and of the future to create an innovationfriendly level playing field for cutting edge companies, including SMEs, within the EU Single Market.

The MedTech Europe Cardiovascular Sector Group welcomes the EU Safe Hearts Plan's flagship initiative on an EU protocol on cardiovascular health checks. A structured, harmonised and risk-based EU protocol is essential to move Member States from fragmented, opportunistic detection towards systematic screening, and to deliver on the Plan's objective of reducing premature CVD mortality by 25% by 2035.

MedTech Europe, the European association of medical technology manufacturers, including medical devices, in vitro diagnostic medical devices and digital health, welcomes the possibility to share feedback and relevant evidence for the upcoming Integrated Climate Resilience and Risk Management Framework concerning the Health Sector and calls on policy makers to holistically address the urgency of building resilient…

Regulation (EU) 1025/2012: Impact, Effectiveness, and Future Improvements Regulation (EU) 1025/2012 is a crucial component of the New Legislative Framework, particularly impactful in the healthcare sector. MedTech Europe strongly endorses this regulation because European harmonized standards are vital.

MedTech Europe welcomes the Digital Fitness Check as a second step to stress-test the complementarity, efficiency, and effectiveness of the digital rulebook that will support Europe's position at the forefront of medical innovation and ensure that patients benefit from advances, more personalised treatments, and better outcomes. By simplification, our sector does not mean deregulation or lowering standards.

MedTech Europe, the European industry association representing manufacturers of medical technologies (medical devices and in vitro diagnostic medical devices- IVDs), takes the opportunity to share its views on the One Substance, One Assessment (OSOA) package of legislative proposals published on 7 December 2023.

MedTech Europe welcomes the European Commission public consultation on the draft Implementing act according to Art. 24(3) to lay down the details and format for the Art. 24- disclosure of information requirement and possibility to comment on the requirement to disclose information on unsold consumer products.

MedTech Europe, the European trade association for the medical technology industry, including diagnostics, medical devices and digital health, welcomes the opportunity to provide its comments and recommendations on the draft Implementing Act laying down harmonised specifications for the labelling requirements according to Articles 7 and 13 of the Batteries and Waste Batteries Regulation (EU) 2023/1542.

MedTech Europe welcomes the opportunity to contribute to the European Commissions consultation on ecodesign requirements for iron and steel products under the Ecodesign for Sustainable Products Regulation. Please see our position in the attached document.

MedTech Europe welcomes the draft Implementing Regulation on MDR/IVDR Annex VII and broadly supports the direction taken. The text introduces important operational provisions which will bring urgently needed predictability, transparency and consistency to the conformity assessment of devices under MDR and IVDR.

The healthcare sector is an interconnected environment,bringing together a diverse range of stakeholders who play a vital role in advancing patient care,scientific innovation and public health.In this context, relationships with Healthcare Professionals and Healthcare Organisations are of strategic importance.The significance of these engagements has fostered a strong awareness of the responsibilities they entail…

The European Health Data Space (EHDS) Regulation represents an important step towards enabling the secure, trustworthy and efficient secondary use of electronic health data across the European Union. MedTech Europe welcomes the Commissions efforts to operationalise the EHDS by specifying requirements for dataset descriptions.

The European Health Data Space (EHDS) Regulation stands as a landmark initiative that has the potential to transform healthcare by improving access to and the use of electronic health data, fostering innovation, and strengthening Europes competitiveness in the health sector.

MedTech Europe, the European trade association representing manufacturers of medical technologies, welcomes the opportunity to share its views on the draft delegated act put forward by the European Commission, aiming to implement the Stockholm Convention listing of Medium Chain Chlorinated Paraffins (MCCP), as adopted at COP-12 in Spring 2025.

The medical technology industry is at the forefront of public health emergencies. Providing key medical countermeasures such as diagnostic technologies, ventilators, surgical masks and gloves, oxygen systems, drug and vaccine delivery devices and digital healthcare solutions were all essential during not only the COVID-19 pandemic but several other public health emergencies which emerged before and since.

MedTech Europe, the European trade association for the medical technology industry including diagnostics, medical devices and digital health, welcomes the opportunity to provide feedback on the draft Commission Delegated Regulation amending EU Regulation No 649/2012 on the export and import of hazardous chemicals. Please find our comments and recommendations in the attached document.