Healthcare, competitiveness, innovation and simplification
News
20 May 2026
Healthcare, simplification

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. 

Biotechnology

The Biotech Act can strengthen Europe’s biotechnology ecosystem by making regulatory pathways more efficient and improving coordination at EU level. It can also support the responsible use of data and AI in research and manufacturing. These improvements will only have an impact if they are implemented consistently and work in practice for companies operating across several Member States.

Europe also needs incentives that match the scale and risk of biotechnology investment. A strengthened supplementary protection certificate extension would help ensure that faster procedures lead to more research, clinical activity and manufacturing in Europe. The framework should remain science based and open to international cooperation, while supporting diverse supply chains and the skills needed for long-term competitiveness.

Medical technology

The targeted revision of the MDR and IVDR is a welcome step toward a more workable medical technology framework. It would replace rigid certification cycles with risk-based reviews and make certain post-certification changes easier to manage. By recognising real-world evidence and creating clearer routes for breakthrough devices, the proposal would strengthen Europe’s position as a launch market for medical technologies.

Further changes would give companies greater certainty and better support innovation. Policymakers should clarify the rules for drug device combination products and ensure that reprocessing rules keep patient safety at the centre. Labelling changes should remain subject to appropriate oversight. Health institution exemptions should also be carefully balanced so they do not weaken patient safeguards or distort competition.

The MDR and IVDR must also align properly with wider EU legislation, including the AI Act and cybersecurity rules. Clearer timelines and a single reporting approach would help avoid duplication. A more flexible framework would make Europe a more attractive place to launch medical technologies and improve patient access across the EU.

Related items

Position Paper
22 Oct 2026

Industry calls for repeal of the SCIP database

AmCham EU has joined over 30 industry associations in calling on EU co-legislators to confirm the repeal of the Substances of Concern In articles as such or in complex objects (Products) (SCIP) database, as proposed in the Environmental Omnibus. SCIP costs companies around €225 million a year, yet its intended users, recyclers, barely use it. The Commission itself acknowledges that waste operators find the data unusable and most companies lack the resources to maintain millions of notifications. Repeal would remove a disproportionate reporting layer while keeping obligations for suppliers to inform customers about substances of very high concern. Any future approach should build on existing obligations, not add new ones.

Environment
Simplification
Read more
Read more about Industry calls for repeal of the SCIP database
Blog
14 Oct 2026

The Single Market is only as simple as its Member States make it

This blog is authored by Malte Lohan, CEO, AmCham EU.

What exactly is ‘single’ about a market where the same product needs different national markings, a cyber incident can require dozens of reports and a professional qualification may stop being recognised at the border?

These examples come from different sectors, but they point to the same contradiction. The EU creates common rules, yet companies still encounter national requirements that divide Europe into separate markets in practice.

The stakes are high for American companies invested in Europe. The United States is the largest single source of inward foreign direct investment (FDI) into the EU. In 2025, American companies invested more in Europe (53%) than they did the rest of the world combined. This has been the case for decades. Much of this appeal lies in the promise of a large, prosperous Single Market.

Yet there are signs that this position is coming under pressure. While Europe remains the leading destination for US investment, its share of total US outward FDI has fallen to its lowest level in more than four decades. More recent indicators point in the same direction too. EY’s 2026 European Investment Monitor found that 943 US companies invested in Europe last year, 16% below the annual average of 1,124 over the previous five years. To reverse these trends, Europe needs to make itself a more attractive place to invest, beginning with a more integrated Single Market.

That is why the simplification agenda cannot lose steam – in Brussels and national capitals. In her September State of the Union address, European Commission President Ursula von der Leyen highlighted the need for EU-wide coordination. ‘Simplification cannot be a one-way street’, she said. ‘All levels have to have skin in the game’.

As EU leaders check in on progress under the ‘One Europe, One Market’ roadmap at this week’s European Council meeting, they should look closely at how national choices affect companies operating across borders. That means addressing three related but distinct problems: gold-plating, uneven implementation and the national barriers that continue to fragment the Single Market.

Simplification
Read more
Read more about The Single Market is only as simple as its Member States make it
News
29 Sep 2026

Building trust without slowing innovation

At RAID 2026, Thibaut L’Ortye, Chief Policy and Public Affairs Officer, AmCham EU joined a panel discussion on EU-US regulatory approaches to technology. Taking place on Tuesday, 29 September 2026, the discussion explored how transatlantic cooperation can focus on shared outcomes rather than identical rulebooks, including on cybersecurity, AI safety, consumer protection and resilient supply chains. Mr L’Ortye also highlighted the wider conditions needed to strengthen Europe’s competitiveness.

Industry
Simplification
Read more
Read more about Building trust without slowing innovation