MedTech Europe in the headlines in May 2026

Posted on 04.06.2026

Could do better: MedTech Europe supports MDR/IVDR revision plan but wants more

MedTech Europe published on 5 May 2026 its detailed position on the European Commission’s proposed revision of the Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR), supporting the overall direction of the reform while calling for targeted changes to translate the framework into workable outcomes. The press release was picked up by several media:

In Medtech Insight, MedTech Europe voiced support for the direction of the European Commission’s MDR/IVDR proposed reform, but called for further changes to ensure workable outcomes for industry. MedTech Europe’s 39-page response to the Commission’s proposals covers a lot of ground – and was worth the wait, says Petra Zoellner, Director Regulatory Affairs (IVDR & MDR).

POLITICO noted that the European Commission’s proposal to revise MDR/IVDR “provides a solid basis for reform,” says medical devices lobby MedTech Europe, but some targeted amendments are needed to meet “the proposal’s own ambition.”

Euractiv highlighted that MedTech Europe backed the European Commission’s proposed revisions to the MDR/IVDR, but called for targeted changes to make the framework workable. The group identified several areas needing improvement, including more effective innovation pathways, greater legal clarity around the integration of AI requirements, and a more proportionate approach to cybersecurity reporting.

‘Seize the global initiative,’ MedTech Forum 2026 tells European leaders

Simplified regulation, more momentum towards technology adoption, better investment flows, resilience – if not quite protectionism – and above all “market access predictability in Europe.” These were the top wish-list sentiments voiced at the MedTech Forum 2026. Read a recap in Medtech Insight.

Euractiv highlighted that medtech companies are being forced to navigate complicated rules while waiting for a legal overhaul — a reality that shaped the mood at the annual sector’s get‑together in Sweden, where Brussels was always on the mind. They also made a story from the opening reception, and reported from Sweden’s Public Health Minister, Jakob Forssmed, at the MedTech Forum.

Medical Buyer, one of the event’s media partners, said that the MedTech Forum turned Stockholm into the beating heart of global medtech connections and innovation. Stockholm didn’t just host the event, it became a pulse.

MedTech Europe CEO Oliver Bisazza set out his hopes and aims for EU industry and markets during the MedTech Forum 2026 against a backdrop of cautious optimism in regulatory and strategy circles now the MDR/IVDR revision is getting EU co-legislator attention.

Medical Device Network highlighted that at the MedTech Forum in Stockholm, resilience regarding healthcare continuity and medical device supply during crises emerged as a key theme.

Buying European is not enough: Europe must buy better

In Euractiv, Oliver Bisazza, CEO of MedTech Europe, shared his views on why Europe’s healthcare resilience depends less on buying European and more on buying better. Price-only procurement undermines innovation, outcomes and competitiveness. Revising EU procurement rules to prioritise quality and value would strengthen supply security, patient care and Europe’s medical technology industry.

Medtech Europe responds to AI Act provisional agreement

After the EU Council presidency and European Parliament reached a provisional agreement on amendments to the AI Act, MedTech Europe, which had lobbied for simpler rules, expressed disappointment at the results of negotiations. “The agreement adds an unnecessary layer of complexity to a sector already operating under some of the world’s most stringent oversight,” Alexander Olbrecht, Director of digital health and medtech value, said to POLITICO.

What U.S. manufacturers need to know about EU’s medical device rules fix

For years, U.S. medtech companies eyeing the European market have had one recurrent complaint: The EU’s regulatory system for medical devices was too slow, too complex, and too unpredictable. They weren’t wrong. But the system is now changing—faster than many realise. Petra Zoellner, Director, Regulatory Affairs (IVDR and MDR) at MedTech Europe, shared her insights in Medical Product Outsourcing.

For more information, please contact Dominika Suchonova, Manager Communications.