MedTech Europe

MedTech Europe welcomes the opportunity to provide feedback on the Digital Simplification Package (Digital Omnibus) which represents a timely initiative to enhance regulatory coherence and support Europes competitiveness.

Ensuring Europes competitiveness and patients timely access to innovation depend on reducing and ultimately overcoming the current fragmentation of digital compliance requirements. The European Unions complex digital regulations, which also apply to digital health solutions, were originally framed for the wider digital economy, leaving certain sector-specific considerations insufficiently addressed.

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.

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.

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 - the European trade association for the medical technology industry, including diagnostics, medical devices, and digital health - supports the objective of the Packaging and Packaging Waste Regulation (PPWR) proposal to prevent or reduce the adverse impacts of packaging waste on the environment and human health.

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 review of the requirements for packaging and other measures to prevent packaging waste.

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 welcomes the proposal for a European Competitiveness Fund (ECF) as an important step toward a more coherent and strategic use of EU funding. The ECF has the potential to strengthen Europes industrial competitiveness, technological sovereignty, and health system resilience.

As the association representing the medical technology sector, MedTech Europe welcomes the recognition in the inception impact assessment that pharma health solutions bring about technological advances, and the inclusion of the potential of the digital transformation of health and care.

MedTech Europe, the European trade association representing the medical technology industry including diagnostics, medical devices and digital health, would like to provide its response to the European Commission’s adoption consultation on the proposed Artificial Intelligence Act (AIA).

Artificial Intelligence (AI) in medical technologies has the potential to deliver on the promise of better healthcare in Europe. To optimise the value of AI in the healthcare sector, policies need to remain flexible and follow the evolution of technological development, allowing space for technology to thrive.

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 call for evidence for an impact assessment regarding the initiative on the revision of the EU Waste Framework.

MedTech Europe’s response to the Public Consultation on the European Commission’s proposal for a Directive on Corporate Sustainability Due Diligence 23 May 2022 Introduction We welcome the European Commission’s proposal addressing human rights and environmental due diligence in global supply chains.

Opening of the attached position paper · the full paper is on the Commission’s record (source link above)

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 is the European trade association for the medical technology industry, including diagnostics, medical devices, and digital health. MedTech Europe supports the ambition towards more sustainable products in the European Union and circular business models.

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 opportunity to provide feedback on the upcoming revision of Regulation (EC) No 1272/2008 on hazard classification, labelling and packaging of chemicals (the CLP Regulation). We look forward to continuing engaging in this initiative and other policy initiatives within the Chemicals Strategy for Sustainability.

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.

Please find MedTech Europe’s full answer attached. MedTech Europe shares the Commission’s objective to address barriers for data sharing. In our view, the Data Act needs to provide clear definitions in alignment existing legislation. Where health data is generated as part of the authorised use of medical devices, healthcare professionals play a crucial role in interpreting the data.

MedTech Europe welcomes the opportunity to provide feedback on the proposed European Health Data Space (EHDS) regulation, please find our full answer attached. • The EHDS regulation is meant to complement other EU laws, including existing sectoral and horizontal legislation.

MedTech Europe supports the project of the European Health Data Space (EHDS). The medtech industry is at the heart of the health data ecosystem. The industry’s digital health solutions annotate and enrich data to turn raw data into datasets of high value. Innovation in the development of new treatments and protocols is highly dependent on its ability to access and appropriately utilise health data.

MedTech Europe supports the European Commission’s ambition to ensure a competitive, circular, sustainable and safe value chain for all batteries placed on the EU market. MedTech Europe considers the proposed Regulation a reasonable renewal of the existing Battery Directive.

MedTech Europe supports the European Commission’s commitment to ensure a competitive, circular, sustainable and safe value chain for all batteries placed on the EU market. Our submission focuses on the potential impact of a ban on primary batteries on the medical technology sector (medical devices and in vitro diagnostic medical devices (IVDs)).

MedTech Europe welcomes the opportunity to respond on the proposal for a European Data Governance Act (DGA). We support the European data strategy and specifically the sectoral project of the European Health Data Space. THE MEDTECH INDUSTRY delivers products, services or solutions that improve prevention, diagnosis, treatment, monitoring and management of health and lifestyle.

Feedback to Commission adoption: Review of EU rules on fluorinated greenhouse gases 29 June 2022 SUMMARY • The Commission proposal applies to chemicals that are used in or with medical devices, such as inhalers, anaesthetic gases, blood bank refrigerators, and centrifugation systems.

Opening of the attached position paper · the full paper is on the Commission’s record (source link above)

MedTech Europe, the European trade association for the medical technology industry welcomes the opportunity to provide feedback on the upcoming revision of the Regulation (EC) No 1907/2006 on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH Regulation). We look forward to continuing to engage in this and other policy initiatives within the Chemicals Strategy for Sustainability.

MedTech Europe is the European trade association for the medical technology industry including diagnostics, medical devices and digital health. Our members are national, European and multinational companies as well as a network of national medical technology associations who research, develop, manufacture, distribute and supply health-related technologies, services and solutions.

Digital health and care technologies can innovate and improve access to care and quality of care and make healthcare delivery more efficient. Providing secure devices and services and keeping users and patients safe and protected is a core goal of the medical technology industry.

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.

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, 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…

MedTech Europe takes note of the European Commissions proposal to amend the transitional measures in the Medical Devices Regulation (EU) 2017/745 and welcomes its recognition of the ongoing urgent risks of medical device shortages in Europe stemming from the Regulation implementation challenges.

MedTech Europe welcomes the Proposal for a Regulation on substances of human origin adopted by the European Commission in July 2022. We agree that the sector needs updated legislation, and the proposed text reinforces the rules for safety and quality. We are looking forward patients to having smooth access to products, the availability of which is uninterrupted on the European market.

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 consultation regarding the revision of the Union legislation on blood, tissues and cells.

In response to the European Commissions Public Consultation on rationalisation of reporting requirements, MedTech Europe highlights reporting requirements which could be minimised, simplified and/or digitalised in medtech sector whilst maintaining a high level of protection of health, transparency, and traceability to the benefit of patients and users.

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.

We welcome the NIS 2 Directive proposal as an improvement over the current NIS Directive. Relevant sectoral guidance could promote further harmonisation and clarity on how to act when cyberincidents are putting healthcare and patient safety at risk.

As Medtech Europe, the association for Medical Technology in Europe, we welcome the opportunity to comment on the Late Payments Directive. Unfortunately we have extensive experience in the healthcare sector with late payments due to a number of reasons and believe that the Late Payments Directive can be improve to improve compliance with its provisions, which are essential for the proper functioning of the internal…

MedTech Europe the European trade association for the medical technology industry, including in vitro diagnostics, medical devices, and digital health welcomes the opportunity to express its recommendations on the Commissions stakeholder consultation on the draft Delegated Act seeking to amend the green list of waste, pursuant to Regulation (EU) 2024/1157 on Waste Shipments.

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 comment to the proposed Regulation on General Product Safety MedTech Europe suggests that the current list of products excluded from the scope of the proposed Regulation be enlarged to add both medical devices and in vitro diagnostic medical devices (IVDs), similarly to what is envisaged for medicinal products, for the following reason.

Opening of the attached position paper · the full paper is on the Commission’s record (source link above)

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.

As per the document attached that provides MedTech Europe more detailed feedback, we welcome the opportunity to provide feedback to the proposed revision of the EU Product Liability Directive (85/374/EEC) (PLD).

MedTech Europe, the European trade association for the medical technology industry including diagnostics, medical devices and digital health welcomes the opportunity to provide comments on behalf of the medical technology industry to the European Commission on the Inception Impact Assessment regarding the revision of the Product Liability Framework.

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.

MedTech Europe welcomes the opportunity to respond to the public consultation on the draft Commission Implementing Act on HealthData@EU, adopted pursuant to the European Health Data Space (EHDS) Regulation. We support the Commissions objective of establishing a secure, interoperable and trustworthy cross-border infrastructure for the secondary use of electronic health data.

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 welcomes the objective and the proposed text on the extended role of the ECDC, as part of the European Health Union and suggestes to take the following considerations into account: 1. Involvement of Civil Society (Articles 5a and 5b): a.COVID-19 has demonstrated the need to involve the civil society in order to combat public health threats – in particular prevention, preparedness and response planning…

MedTech Europe is the European association of medical technology manufacturers, including digital health products that fall under the scope of our sectoral regulations, some of which would fall under the scope of the proposed Artificial Intelligence Liability Directive (AILD).

Regaring the proposed Regulation on the reinforced role of EMA, MedTech Europe suggests to take the following considerations into account (full position attached): 1. Involvement of Civil Society in the Executive Steering Committee on Medical Devices (Art19): a.COVID-19 has demonstrated the need to involve the medical technology industry and other partners of civil society in an ongoing dialogue throughout the full…

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.

MedTech Europe welcomes the objective of the European Commission’s proposed ‘Health Union’ package of 11 November 2020. Better coordination and pooling of efforts are needed across the Union to strengthen Europe’s preparedness to tackle future public health emergencies, and the proposed Regulation on serious cross-border threats to health constitutes an important step in this direction.

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.