F. Hoffmann-La Roche Ltd

Roche welcomes and fully supports the European Commission's efforts to simplify and improve the EU rules for medical devices and in vitro diagnostics. We appreciate the opportunity to comment. Our comments on the revision proposal highlights changes that are particularly welcome and those needing clarification to address challenges and to safeguard patient safety and access to innovation. Feedback attached.

F. Hoffmann-La Roche Ltd welcomes the opportunity to give input on the IVDR/MDR targeted revision. In-vitro diagnostics and medical devices are not only critical products in themselves to diagnose and treat medical conditions. They are also enablers for clinical research and to guide and administer pharmaceutical treatments. Our companys extensive portfolio comprises medical devices, IVDs and pharmaceuticals.

Roche supports EFPIAs response to this consultation. Deeply rooted in Europe, Roche is concerned that the future legislation, if adopted as is, will have a detrimental impact on access to innovation for EU patients and will exacerbate innovation and competitiveness gaps between the EU and other regions of the world.

Roche supports EFPIAs response to this consultation. Deeply rooted in Europe, Roche is concerned that the future legislation, if adopted as is, will have a detrimental impact on access to innovation for EU patients and will exacerbate innovation and competitiveness gaps between the EU and other regions of the world.

Roche expects fast-paced developments in medicines, devices, data and digitalisation to converge into more personalised healthcare solutions, with increased benefit to society at a significantly reduced cost. While this evolution has started and will continue over the next decades, details are hard to predict.

Roche feedback to the European Commission’s proposed Regulation of Artificial Intelligence (the “AI Act”) F. Hoffmann-La Roche (Roche) is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives.

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

Roche welcomes the European Commission's proposal for the Biotech Act. As one of the world's largest biotech companies, we view this Act as a critical opportunity to restore Europe's competitiveness in the global life sciences landscape.

Roche welcomes the objective of the European Commission's Biotech Act initiative. Europe can regain competitiveness by transforming into an efficient ecosystem that leverages the single market with unified rules, fostering Research & Development for innovative medicines and integrated solutions.

Roche welcomes the opportunity to provide feedback to the European Commission’s Proposal for a Regulation of the European Parliament and of the Council on the European Health Data Space (EHDS). As the first sectorial area for Common Data Spaces, the success of the EHDS is key to realising the “European strategy for data” (the “Data Strategy”). Please find our full response attached.

To whom it may concern, Roche welcomes the opportunity to provide feedback to the European Commission’s combined evaluation and roadmap/Inception Impact Assessment for A European Health Data Space (EHDS) as an important step towards informing the legislative proposal for the EHDS and realising the European Commission’s “A European strategy for data” released in 2020.

Roche views the proposed DGA as a very positive development and is supportive of the Commission’s intent to enhance data flow and improve data sharing. Roche supports the aim of the DGA in line with its feedback to both the European Strategy for Data and the Legislative Framework for the Governance of Common European Data Spaces.

Roche welcomes the opportunity to provide feedback to the European Commission’s Inception Impact Assessment for the Legislative Framework for the Governance of Common European Data Spaces (the “IIA”), as an important step in enabling the future EU data spaces described in the European Commission’s “A European strategy for data” (the “Data Strategy”) released earlier this year.General considerations: At large, Roche…

F. Hoffmann-La Roche Ltd (Roche) welcomes the European Commissions Safe Hearts Plan and the initiative to establish a Council Recommendation on cardiovascular (CV) health checks by Q4 2026. Roche endorses the EFPIA and MedTech Europe positions, supporting key elements such as the Know Your Numbers by 35 baseline assessment, the combination of systematic and opportunistic screening (make every contact count), and the…

Roche is committed to support the improvement of the regulatory environment in Europe and welcomes the opportunity to contribute to the revision of the pediatric and rare diseases legislation. We believe that the revision should not only address current bottlenecks but more importantly, and in line with the Pharma strategy, should make the legislation future-proof and consider also future treatment options and…