MedTech Europe has submitted its response to the European Commission’s public consultation on the proposed extension of the Carbon Border Adjustment Mechanism (CBAM) to downstream products, anti-circumvention measures and electricity sector rules. The response highlights concerns about implementation challenges for medical device manufacturers, particularly regarding data collection requirements and conflicts with existing Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR) frameworks. MedTech reports that there is no evidence of carbon leakage in the medical technology sector to justify such an extension, warning that including medical devices and in vitro diagnostic devices (IVDs) regulated under Regulations (EU) 2017/745 and 2017/746, along with their iron-, steel- and aluminium-intensive components, would contradict EU goals on sustainable prosperity and competitiveness. The response highlights disproportionate administrative burdens and costs, risks of manufacturing leakage out of the EU, and potential negative effects on environmental outcomes and patient access.

MedTech Europe has released its response setting out its views following the entry into force on 1 August 2024 of Regulation (EU) 2024/1689 laying down harmonised rules on artificial intelligence (the EU AI Act). While acknowledging efforts to increase clarity, MedTech Europe highlights the need for further alignment between the EU AI Act's requirements for high-risk AI systems and Regulation (EU) 2017/745 (the Medical Devices Regulation (MDR)) and Regulation (EU) 2017/746 (the In Vitro Diagnostic Medical Devices Regulation (IVDR)). Concerns are raised about potential diverging interpretations and inconsistencies arising from the simultaneous application of these regulations. MedTech Europe recommends developing European Commission guidelines with stakeholder input, aligning EU AI Act standards with existing vertical standards, ensuring a single conformity assessment procedure led by sectoral processes, and providing a clear pathway for clinical and performance evaluation of medical technologies. The document emphasises the importance of consistency among horizontal and vertical standards, leveraging a single set of technical documentation, and allowing notified bodies to use existing processes for AI-enabled medical technologies. Additionally, MedTech Europe advises exempting investigational devices and devices for performance studies from the EU AI Act's requirements, as these processes are critical for gathering necessary clinical evidence and ensuring patient safety under the MDR and the IVDR. MedTech Europe concludes by recommending timely implementation guidelines and stakeholder consultation to ensure comprehensive regulatory alignment for the medical technology sector.

MedTech Europe has submitted recommendations to the European Commission's call for evidence on the forthcoming European Innovation Act, following a consultation that closed in early October 2025. The trade association calls for explicit recognition of medical technology as a strategic sector and requests streamlined pathways from research to market without substituting urgently needed sectoral reforms, including planned Regulation (EU) 2017/745 (Medical Device Regulation (MDR)) and Regulation (EU) 2017/746 (In Vitro Diagnostic Regulation (IVDR)) reforms scheduled for late 2025. Key recommendations include establishing formal coordination mechanisms between EU Directorates-General, implementing innovation-friendly public procurement using Most Economically Advantageous Tender (MEAT) criteria as the default above EU thresholds, and creating regulatory sandboxes for medical technology breakthrough innovations. MedTech Europe also proposes establishing a health innovation coordination platform bringing together member states, EU institutions, regulators, and industry stakeholders to reduce Single Market fragmentation. The submission emphasises closing scale-up finance gaps and supporting late-stage validation and first adoption in health systems, while calling for the Act to complement rather than replace dedicated sectoral legislative reforms.

MedTech Europe sets out its response to the EU consultation on Regulation (EU) 2024/1157 harmonising the classification of certain waste types (so-called 'green-listed' waste) to facilitate their shipments across borders. It welcomes the European Commission’s efforts to modernise waste rules and promote recycling but warns that some proposed measures, such as extending the Prior Informed Consent procedure to all intra-EU shipments of e-waste, could create significant administrative burdens, delays and costs. It emphasises the need for clear definitions of waste and end-of-life products, uniform classification systems, and consistent templates and guidelines across the EU. MedTech Europe also urges the maintenance of 'green-list' status for non-hazardous intra-EU e-waste shipments and supports streamlined approval, renewal and documentation procedures, ideally through EU-level or digital systems. MedTech Europe provides a set of general improvement suggestions to future-proof the waste shipment rules that include calling for specific regulation to address products/waste that is not used by consumers and for waste from clinical trials and aligning these rules with medical device legislation. It points out that 'a perfectly safe product for use becomes hazardous under the WSR and the Basel Convention. We recommend aligning all these frameworks to facilitate compliance for intra-EU shipments by, for example, establishing contamination thresholds aligned with the existing legal requirements under the other EU acquis'.

MedTech Europe has submitted its response to the European Union's consultation on the targeted evaluation of Regulation (EU) 2017/746 (In Vitro Diagnostic Medical Devices Regulation (IVDR)) and  Regulation (EU) 2017/745 (Medical Devices Regulation (MDR)) on 25 March 2025. The response outlines eight key recommendations including streamlining conformity assessments, reducing administrative burden, optimising post-market surveillance requirements and establishing a unified governance structure. The industry body calls for better alignment between IVDR and MDR frameworks while promoting European CE-marking as an international standard.

MedTech Europe, alongside Association of the European Self-Care Industry, MedTech & Pharma Platform and European Coordination Committee of the Radiological, Electromedical and Healthcare IT Industry, has issued a joint position paper expressing serious concerns regarding the updated Medical Device Coordination Group 2019-6 Requirements (revision 5). The organisations have highlighted that whilst the revision provides a framework for structured dialogue, it fails to address the critical need for pre-submission clinical strategy discussions between manufacturers and Notified Bodies. The paper emphasises that this omission is causing significant challenges for device continuity and industry compliance, with data showing 50% of Medical Device and 30% of In Vitro Diagnostic medical device applications failing due to clinical evaluation issues. The organisations are calling for urgent action from the European Commission to implement clear provisions allowing high-level clinical strategy discussions during pre-submission phases, aligning with international best practices.

MedTech Europe, along with other European industry bodies, has called for EU regulatory oversight of Third-Party Litigation Funding (TPLF). The organisation has expressed concern over the unregulated growth of TPLF, which it claims encourages profit-driven litigation financing and potentially abusive practices. MedTech Europe advocates for a regulatory framework that promotes transparency, ensures fair compensation, and protects all parties from exploitation. The aim is to safeguard the integrity of civil justice and maintain a competitive business environment across the EU.

MedTech Europe has released a statement urging the European Commission to prioritise the competitiveness of the medical technology industry for the benefit of patients in Europe. MedTech Europe has also welcomed the Commission's President's, Ursula Von der Leyen, call for a major European competitiveness boost and her commitment to make business quicker and effortless. Notably, the medical technology industry stands ready to support the Commission and EU co-legislators in delivering on this important political agenda for 2024–29.

MedTech Europe has issued an open letter calling for urgent reforms to the EU's medical technology regulatory frameworks. The organisation has highlighted the need for structural changes to maintain Europe's competitiveness in healthcare innovation.

MedTech Europe and various medical associations have issued an open letter to the European Commission President, Ursula von der Leyen, expressing concerns over potential new trade tariffs on medical technology imports. The letter requests exclusion of medical technology from any new trade defence measures, citing risks to European healthcare systems' supply chains and costs. The association emphasises the need to protect the EU medical technology sector's competitiveness while maintaining access to essential healthcare products.

MedTech Europe has welcomed the Budapest Declaration, which commits to strengthen Europe's competitiveness, prosperity, sovereignty, and global influence. It calls for recognising the medical technology sector as a strategic pillar in implementing the new EU Competitiveness Deal, and recommends that various actions are taken to unlock competitiveness drivers in the medical technology sector. These include reforming the sector's regulatory system, namely Regulation (EU) 2017/745  (the Medical Devices Regulation (MDR)) and Regulation (EU) 2017/746 (the In Vitro Diagnostic Medical Devices Regulation (IVDR)), synchronising horizontal regulations with the MDR and IVDR, enabling investments in research and innovation for medical technology, and making strategic investments in efficient and sustainable healthcare systems supported by digital health and medical technologies. These measures aim to strengthen Europe's global health and innovation leadership, meet sustainability goals, and address patient and healthcare provider needs.

MedTech Europe has published a position paper welcoming the European Commission’s proposal for a European Competitiveness Fund (ECF). It states that the ECF represents a key opportunity for the medical technology and digital health sectors to bridge the gap between research and large-scale deployment, maintain Europe’s leadership in health innovation, and support sustainable and resilient healthcare systems. However, MedTech Europe stresses that the ECF must include clear, predictable, and operational mechanisms to safeguard long-term investment in health research, development, and innovation; ensure the effective deployment and scale-up of health innovations; reinforce health data, cybersecurity, and sustainability infrastructures; and embed health-resilience objectives in national and regional investment planning.