MedTech Europe has voiced concerns regarding Regulation (EU) 2021/2282 known as Health Technology Assessment (HTA) Regulation and its implementation. The organisation has called for a comprehensive roadmap to address uncertainties throughout the HTA's implementation phase which will begin to apply from 12 January 2025. MedTech Europe emphasises the need for clarity on Joint Clinical Assessment (JCA) processes, multi-stakeholder participation, and definitions within implementing acts. The specified several points of clarification required in the JCA process such as regarding the identification and planned reporting on emerging health technologies and the capacity to deal with evidence plans, and, particularly how Member States’ differing reimbursement regimes will use JCA reports and how this improves value versus existing national HTA processes. The organisation stresses that such guidance is crucial to ensure the HTA contributes to innovation, competitiveness, and timely access to novel care technologies for European patients and healthcare systems.

MedTech Europe issued an open letter to the EU Competitiveness Council on 11 March 2025, urging ministers to prioritise life sciences in the EU Competitiveness Compass. The letter calls for structural reform of Regulations (EU) 2017/745 and 2017/746 by early 2026, alongside better alignment of regulatory requirements across policy domains. The association recommends strategic healthcare infrastructure investments through the Multiannual Financial Framework and implementation of value-based procurement to enhance sector competitiveness while maintaining safety standards.

MedTech Europe has published a position paper proposing targeted reforms to ensure the coherent implementation of EU digital legislation affecting the medical technology sector. The paper responds to the European Commission’s regulatory simplification agenda and outlines recommendations to align horizontal digital laws with existing sector-specific frameworks, namely Regulation (EU) 2017/745, the Medical Devices Regulation (MDR), Regulation (EU) 2017/746, the In Vitro Diagnostic Medical Devices Regulation (IVDR), and Regulation (EU) 2025/327, the European Health Data Space (EHDS).

MedTech Europe has published a statement on Commission Implementing Regulation (EU) 2026/977, which introduces harmonised procedural requirements for conformity assessment activities carried out by notified bodies under the Medical Devices Regulation (EU) 2017/745 (MDR) and In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR). The association stated that the regulatory framework for medical technologies is at a pivotal moment, citing slow and unpredictable conformity assessment timelines and administrative complexity under the MDR and IVDR regimes. It welcomed the Regulation’s focus on simplification, greater procedural consistency, transparency and international cooperation, stating that the measures are intended to improve predictability in conformity assessment procedures while broader revisions to the MDR and IVDR continue through the EU legislative process.

MedTech Europe has advised European manufacturers to review two section 301 investigations launched by the US Trade Representative (USTR) that may have implications for medical technology industry. The investigations, initiated under the Trade Act 1974, examine trade practices across a range of economies, including the EU, Switzerland, Norway and the UK. The first focuses on structural excess capacity and productions in manufacturing sectors, highlighting significant sectoral trade surpluses in EU countries such as Germany and Ireland. The second examines alleged failures to address forced labour across 60 economies. Stakeholders are invited to submit comments by 15 April 2026 to inform the USTR’s assessment and any potential trade measures. While neither investigation specifically targets the medical technology sector, MedTech Europe notes that the outcomes could affect European manufacturers exporting to the US and encourages potentially impacted stakeholders to review the notices and consider responding to the consultation.

MedTech Europe has published a statement, responding to the European Commission’s Digital Omnibus package, welcoming its intention to simplify digital legislation, but calling for clearer and more coherent digital regulations for the medical technology sector. It warns that overlapping and fragmented rules under the Artificial Intelligence Act, Cyber Resilience Act, Medical Devices Regulation (EU) 2017/745 (MDR) and In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) hinder innovation and patient access. MedTech Europe supports plans for pre-market testing and unified assessments but urges refinement of key definitions and an extended compliance deadline to 2 August 2029. It also cautions that merging data laws may add complexity and calls for proportional, sector-specific approaches to health data under the European Health Data Space (EHDS) to safeguard Europe’s medical innovation leadership.

MedTech Europe has announced that it is among the signatories to a joint industry statement urging the European Commission to base the forthcoming Circular Economy Act (CEA) on Article 114 of the Treaty on the Functioning of the European Union (TFEU), the internal market legal basis. The statement supports the EU’s circular economy objectives but argues that harmonised EU-wide rules are necessary to reduce fragmentation in waste management systems and enable a functioning single market for secondary raw materials. The signatories point to disparities in municipal waste performance across Member States, including continued reliance on landfill in several countries and uneven progress towards the 2025 recycling targets, and state that divergent national frameworks are among the most reported single market barriers. The joint statement calls on the Commission and co-legislators to maintain the internal market legal basis in drafting the CEA and notes that choosing Article 192 TFEU (environmental legal basis) instead could affect the scope and implementation of the legislation and adversely impact efforts to support the EU’s transition to a circular and climate-neutral economy.

MedTech Europe, together with 35 national associations, has urged the European Commission to take swift action on regulatory challenges affecting the medical device and diagnostic sectors. While EU officials are already collecting evidence to support future reforms of the medical device and in vitro diagnostic regulations, which are meant to simplify and improve efficiency, the signatories of the open letter argue that immediate relief is also essential. They call for a combination of short-term measures alongside longer-term legislative reforms. In particular, the letter asks for an implementing act to standardize the work of notified bodies, pilot projects for regulatory pathways covering orphan, pediatric, and breakthrough devices, and a targeted delay of re-certification requirements for certain products. According to MedTech Europe, harmonizing rules for notified bodies would help reduce duplication, speed up assessments, and ease the overall regulatory burden. The proposed postponement of re-certification deadlines is seen as necessary to avoid bottlenecks that could disrupt the supply of devices ahead of 2028. Looking further ahead, the associations want amendments to both MDR and IVDR that reflect the specific needs of each sector, alongside the creation of a single governance structure to oversee notified bodies and the CE-marking system, which they consider vital to the future of European medical technology regulation.

MedTech Europe commissioned the report 'Decarbonising Healthcare: How a Competitive MedTech Industry Can Contribute' from the Boston Consulting Group (BCG), with contributions from member companies and a dedicated Steering Committee. The report outlines how the European medical technology (MedTech) sector can support healthcare decarbonisation while enhancing competitiveness, in alignment with the EU’s legally binding target of net zero greenhouse gas emissions by 2050 under the European Climate Law.

MedTech Europe has published guidance on the implementation of the European Health Data Space (EHDS) Regulation ahead of its publication in the Official Journal of the EU. The trade association emphasises three key areas for successful implementation: stakeholder dialogue through the EHDS board, harmonised application across EU member states, and workable approaches for Electronic Health Record systems. The guidance highlights the need for clear direction on Health Data Access Bodies' responsibilities and safeguards for trade secrets and IP rights.

MedTech Europe has published a position paper highlighting concerns about the interpretation of post-market clinical follow-up (PMCF) requirements under Regulation (EU) 2017/745 on medical devices (Medical Devices Regulation ( MDR)), particularly regarding low-risk devices with a demonstrated safety profile.

MedTech Europe has published a position paper on the proposed revisions to the Corporate Sustainability Due Diligence Directive (CSDDD) and the Corporate Sustainability Reporting Directive (CSRD). MedTech supports confining due diligence obligations to Tier 1 suppliers and welcomes the elimination of the harmonised EU civil liability regime. Additionally, MedTech advocates for the extension of monitoring periods from 12 months to five years, capping penalties to 5% of turnover, and maintaining limited assurance requirements under the CSRD. Overall, the paper seeks to reduce administrative burdens while ensuring that sustainability reporting frameworks remain effective.