MedTech Europe has issued a position paper outlining ten key recommendations for implementing the EU Green Deal in the healthcare sector. The paper advocates for a holistic approach to sustainability in healthcare, emphasising the need for system-wide changes to achieve environmental and financial sustainability. Key proposals include accelerating the adoption of renewable energy, fostering collaboration among healthcare actors, leveraging digital technologies, harmonising rules to complete the European single market, and establishing a sustainable finance framework for research and innovation. The organisation also calls for the promotion of value-based procurement, the removal of regulatory barriers to sustainability, and the development of realistic transition pathways for medical technology manufacturers. Additionally, MedTech Europe emphasises the importance of enabling circularity in medical technologies and streamlining reporting requirements to ensure they are workable and fit for purpose.

MedTech Europe has written a letter to the European Commissioner for Health and Food Safety, Stella Kyriakides, proposing three areas of action to reform Regulation (EU) 2017/ 746 (the In Vitro Diagnostic Medical Devices Regulations (IVDR)) and Regulation (EU) 2017/745 (the Medical Device Regulation (MDR)) (together the medical technology regulations). The letter urges Stella Kyriakides to implement these changes urgently to enhance patient protection by ensuring the availability of devices and overcoming discontinuations of medical technology. Introducing legislative reforms for the IVDR and MDR is recommended as an immediate outcome for the targeted evaluation which ends in 2025, to ensure that the regulations deliver on their objectives and are being efficient, innovative-friendly and well-governed.  Furthermore, binding measures are recommended as urgently as possible to support the availability of medical devices and specific measures on an ongoing basis are urged to improve the implementation of the regulations.

MedTech Europe has published a Reflection Paper calling on the Medical Device Coordination Group (MDCG) to adopt a risk-based, rather than quota-based, sampling approach for Class B and Class C devices to reduce the burden stemming from duplicative sampling and focus the resources of the system on higher risk devices.​ The industry body emphasises that in vitro diagnostic (IVD) device manufacturers have increased technical documentation and administrative burden under the Regulation (EU) 2017/746 (IVDR). Notified Bodies dedicate most of their time in sampling lower risk Class B and Class C devices, rather than highest risk Class D devices. Class B and C diagnostics together make up over 90% of the EU IVD market. The Paper notes that the average number of samples taken under IVDR is more than double that under the Medical Devices Regulation (MDR), due to broader scope codes and more grouping categories for IVDs. ​MedTech Europe in this Paper argues that the current system leads to repetitive sampling of the same devices, particularly for SMEs with limited portfolios, offering little added value in terms of safety or performance assurance. The Paper argues that the mandated 15% sampling rate for technical documentation per certification cycle is disproportionate, especially when compared to the 100% review requirement for the highest-risk Class D devices. This quota-based system imposes a significant financial and operational burden on manufacturers, with average costs per technical file review nearing €38,000. ​MedTech Europe proposes a shift to a risk-based sampling model. This seems to take a page from the UK which just had the UK Government respond to a public consultation in support of future regulation that will create a more proportionate risk-based approach to diagnostic device certification that would, in particular, mean that certification of Class B IVDs for the Great Britain market would require UKCA self-declaration and ISO 13485 quality management system (QMS) certification. MedTech Europe proposes to eliminate automatic quotas for Class B devices during surveillance, reducing sampling for Class C devices to 5%, and applying a maximum of 5% sampling during initial certification for devices with stable post-market surveillance. Simulations in the paper show that such an approach would significantly reduce the total cost burden on the sector without compromising safety. The paper calls for the MDCG to revise its guidance to reflect this more proportionate, risk-based strategy

MedTech Europe has published a joint industry statement alongside several European industry associations reacting to the European Commission’s delegated act under article 29 of Regulation (EU) 2025/40 (Packaging and Packaging Waste Regulation (PPWR)). The statement notes the Commission’s decision to introduce a derogation for pallet wrappings and straps from the 100% reuse targets in article 29(2) and (3), stating that these packaging formats are generally designed for single-use load stabilisation and may not be suitable for reuse at scale while maintaining load stability, product protection and transport safety. It also highlights that the 40% reuse target under article 29(1) remains applicable to these formats and calls on the Commission to adopt a delegated act under article 29(18) exempting pallet wrappings, straps and comparable transport packaging solutions where reuse is technically unsuitable.

MedTech for Europe has published a joint statement by a coalition of technology providers, digital infrastructure companies, medical technology companies, and small and medium-sized enterprises (SME)s, urging EU Member States and policymakers not to weaken the EU Digital Omnibus proposal during Council negotiations. The organisations argue that compromise texts from the Cypriot Presidency undermine the proposal’s simplification goals by rolling back EU General Data Protection Regulation (EU GDPR) reforms, rejecting an EU-level Single-Entry Point for cyber incident reporting and retaining restrictive cookie rules. The statement calls for targeted EU GDPR clarifications, harmonised cybersecurity reporting obligations, cookie reforms aligned with technical and market realities and stronger trade secret protections under the EU Data Act, warning that failure to simplify the EU digital rulebook could damage Europe’s competitiveness, innovation and attractiveness for investment. Signatories include, among others, Computer & Communications Industry Association (CCIA Europe), DOT Europe, MedTech Europe and the Information Technology Industry Council (ITI).

MedTech Europe has published a paper setting out its recommendations on the European Commission's proposal to revise the Regulation (EU) 2017/746 (In Vitro Diagnostic Medical Devices Regulation (IVDR). The paper complements MedTech Europe’s broader position on the revision of the Medical Device Regulation (MDR)/IVDR and focuses on characteristics specific to the diagnostics sector.

MedTech Europe has published a reflection paper responding to the European Commission's Chemicals Industry Action Plan released on 8 July 2025. The trade association welcomes several proposed measures including the commitment to publish a REACH revision proposal by Q4 2025, additional time for compliance with revised Classification, Labelling and Packaging (CLP) labelling requirements, and promised clarity on per- and polyfluoroalkyl substances (PFAS) regulation in 2025 and 2026. The paper also addresses the proposed European Chemicals Agency (ECHA) Founding Regulation and new tasks under the 'One Substance, One Assessment' package. MedTech Europe emphasises that medical technology manufacturers, as downstream chemical users, require realistic transition pathways and continued access to essential chemicals where no alternatives exist, particularly for PFAS uses in critical medical applications where patient safety requirements must be maintained.

MedTech Europe has published its response to the European Commission’s consultation on the revision of the EU Cybersecurity Act, supporting stronger EU cybersecurity resilience while calling for a proportionate framework for the healthcare sector. MedTech Europe says the revised framework should avoid overlapping cybersecurity requirements for medical devices already regulated under Regulation (EU) 2017/745 (Medical Device Regulation (MDR)) and Regulation (EU) 2017/746 (In Vitro Diagnostic Medical Devices Regulation (IVDR)). It adds that cybersecurity certification schemes should remain voluntary and aligned with existing EU and international standards. MedTech Europe also welcomes the proposed expansion of the European Union Agency for Cybersecurity’s role in vulnerability coordination and information sharing, while warning against additional reporting obligations that could affect healthcare operations and patient care. It further calls for risk-based supply-chain measures, sector-specific expertise in cybersecurity assessments, and international recognition of certification schemes to reduce duplication and support continuity of care.

MedTech Europe has published a paper outlining its position on the European Commission's proposal to reform the regulatory framework for medical technologies under the Regulation (EU) 2017/746 (In Vitro Diagnostic Medical Devices Regulations (IVDR)) and Regulation (EU) 2017/745 (Medical Device Regulation (MDR)) regimes. The paper outlines the need for a streamlined and predictable regulatory framework that enhances patient access and innovation in European medical technology. It acknowledges that, after nearly a decade of implementation, the current MDR and IVDR have exhibited structural challenges, including protracted conformity assessment timelines, a high administrative burden and divergent interpretations among Member States. The Commission's proposal, supported by MedTech Europe as a strong basis for reform, emphasises simplification, risk-based oversight and digitalisation as a means to reduce undue complexity and redirect regulatory efforts towards genuine risk areas. It further notes the significance of international cooperation, specifically through initiatives such as the Medical Device Single Audit Programme.

MedTech Europe, in collaboration with the Association of the European Self-Care Industry and the European Coordination Committee of the Radiological, Electromedical and Healthcare IT Industry, has published a decision guide flowchart for implementing Article 10a of Regulation (EU) 2024/1860. The regulation, effective from 10 January 2025, requires medical device manufacturers to report supply interruptions and product discontinuations under Regulation (EU) 2017/745 (Medical Devices Regulation (MDR)) and Regulation (EU) 2017/746 (In Vitro Diagnostic Medical Devices Regulation (IVDR)). The guidance incorporates the European Commission's December 2024 Q&A document and is supplemented by a legal opinion from the German Federal Association of Medical Technology.

MedTech Europe has reported the conclusion of negotiations on the EU-India Free Trade Agreement, which eliminates tariffs on the vast majority of medical devices exported from the EU to India. The agreement removes duties that previously reached up to 30% on certain medical device products and includes provisions on customs and trade facilitation, technical barriers to trade, transparency and good regulatory practices. The agreement establishes a dedicated Working Group on Conformity Assessment. MedTech Europe engaged with the European Commission during negotiations to provide technical input for the medical technology sector framework and will continue supporting practical implementation of the agreement.

MedTech Europe has published an update on developments affecting the EU–US trade framework following the introduction of temporary US tariff measures and the US Supreme Court ruling that the International Emergency Economic Powers Act (IEEPA) does not grant legal authority to impose tariffs. In response to this ruling, the US Administration introduced 10% global tariffs under Section 122 of the Trade Act of 1974, which provides temporary authority for tariff implementation on a non‑discriminatory basis for 150 days, expiring in late July 2026. Meanwhile, EU institutions are evaluating the compatibility of these tariffs with EU–US commitments, and the European Parliament has paused its approval process pending further clarification on the tariff’s scope and legal basis.