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Europe’s life sciences sector sits at the heart of the EU’s competitiveness agenda. It supports advanced manufacturing and helps bring new treatments and technologies to patients. Yet companies deciding where to invest need a regulatory environment that is predictable and open to global cooperation. 

The European Commission’s work on the Biotech Act and the targeted revision of the Medical Devices and In Vitro Diagnostics Regulations (MDR/IVDR) offers an opportunity to improve that environment. Both files can help make Europe a stronger location for life sciences investment. 

The EU should use this moment to build a framework that keeps pace with scientific progress. That means faster and clearer procedures. It also means better use of data and intellectual property rules that recognise the realities of global supply chains. 

AmCham EU is relieved to see the European Parliament and Member States reach an agreement on the tariff reduction proposals linked to the EU-US Framework Agreement. The co-legislators’ compromise is a critical step for businesses that rely on a stable transatlantic trade and investment relationship. 

The EU‑US commercial relationship is the largest in the world. It supports millions of European and American jobs and underpins deeply integrated value chains on both sides of the Atlantic. While AmCham EU opposes broad-based tariffs, given political priorities on both sides of the Atlantic, the EU-US Framework Agreement still provides the most realistic path to a workable and more constructive transatlantic trade and investment environment that helps businesses plan and grow in an increasingly volatile global context. The trilogue agreement is a sign that the EU is honouring its commitments under the deal.  

Member States and the European Parliament must now formally confirm this outcome at the earliest possible opportunity. Completing this process will allow the EU and the US to move beyond tariffs and advance the broader cooperation set out in the Joint Statement, including on critical supply chains, non‑market practices and economic security. 

The review of the Cybersecurity Act (CSA 2.0) is an opportunity to build a more coherent, outcome-oriented EU cybersecurity framework. While the proposal recognises fragmentation across the Single Market, further simplification is needed to reduce overlaps and support effective compliance.

A harmonised approach to risk assessment and supervision can strengthen resilience while avoiding duplicative obligations. Certification and supply-chain measures should remain risk-based, objective, technical and aligned with international standards. Structured industry engagement and clear designation thresholds under the ICT Supply Chain Framework and a secure-by-design approach to policymaking will be essential to support cybersecurity and global interoperability. Read more on how CSA 2.0 can strengthen resilience across the Single Market.