MedTech Europe in the headlines

MedTech Europe in the headlines

Posted on 07.04.2026

The recent media coverage showcased MedTech Europe's consistent role as a leading voice in European medical technology, spanning regulatory reforms, global trade developments, and EU-backed innovation initiatives.

Regulation: Strong industry support for MDR/IVDR simplification

The European Commission's proposed simplification of the MDR and IVDR frameworks attracted significant attention. Intertek* highlighted the Commission's intention to reduce compliance costs, clarify conformity timelines, refine risk classifications, and exempt certain low-risk clinical tests. MedTech Europe welcomed these proposals as an essential course-correction for a system that has struggled with bottlenecks and unpredictability since its introduction.

Building on this coverage, MedTech Insight featured an interview by MedTech Europe's Petra Zoellner, who urged EU co-legislators to advance the reforms swiftly. She warned that "we cannot wait years for simplification of the EU regulatory system," underscoring the urgency of ensuring patient access and supporting Europe's medial technology competitiveness.

Trade & tariffs: Ensuring stability in a turbulent global landscape

Trade dynamics also featured prominently in reporting. Euractiv coverage of Europe's "Made in Europe" agenda referenced MedTech Europe's position on ensuring resilient supply chains amid shifting geopolitical pressures. MedTech Europe warned that strict origin requirements, such as "Made in Europe," could trigger severe disruptions.

Further afield, POLITICO noted MedTech Europe's positive reaction to the newly agreed India-EU trade deal, recognising its potential to strengthen cooperation in a high-growth region.

U.S. tariff uncertainty continued to make headlines. After the Supreme Court struck down Trump's "reciprocal" tariffs and he reissued new duties under Section 122, MedTech Europe warned in the Euractiv First Aid newsletter of ongoing unpredictability. With EU devices now facing about 10% tariffs, the association urged for clarity and a stable transatlantic framework to protect medtech supply chains.

On 17 March, Oliver Bisazza, CEO of MedTech Europe, joined a panel discussion "How Does Europe Secure Its Medical Sovereignty?" at the Euronews Health Summit. As geopolitical tensions and supply chain disruptions reshape global healthcare, this panel examined how Europe can secure critical medicines, strengthen domestic production, and reduce strategic dependencies.

The Digital Omnibus: Europe's chance to lead, not just legislate

Europe's AI regulatory push is moving fast, but speed without coherence risks undermining the very innovation it seeks to unleash. MedTech Europe's Alexander Olbrechts set out in Euractiv what proportionate, workable AI rules must deliver for patients and the healthcare sector.

MedTech Europe has welcomed amendments to the AI Act that delay and simplify rules for AI medical devices, but raised several concerns about the Act that have not yet been addressed, including a focus on system readiness, clarified pre-market rules and better harmonisation with international standards.

The European Parliament voted on 26 March 2026 on amendments to the Artificial Intelligence (AI) Act. MedTech Europe said to POLITICO they think the Parliament's approach "does not delete, weaken, or reduce the AI Act's high-risk requirements," instead, these safeguards are incorporated directly into the MDR/IVDR framework.

PFAS: The importance of addressing sector-specific challenges

Following the release of long-awaited opinions on the blanket ban on PFAS from the European Chemicals Agency (ECHA), MedTech Europe's Sigrid Linher said to POLITICO that "it will be essential to address sector-specific challenges and establish transitional arrangements where no functionally and safety-equivalent alternatives to PFAS currently exist."

Research & innovation: IHI's role in strengthening Europe's global competitiveness

Innovation also earned its share of press attention. MedTech Insight reported on the SEISMIC project for minimally invasive brain surgery, funded under the Innovative Health Initiative (IHI). MedTech Europe underscored how IHI programmes enhance Europe's research capacity, bolster resilient healthcare systems, and strengthen the continent's global competitive position in cutting-edge medical technologies.

*Intertek is a conformity assessment body with a direct commercial interest in MDR/IVDR developments.