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EU Regulatory Roundup, June 2023: Medtech Shifts Focus To AI, Data And Digital

 
• By Eliza Slawther

The European Commission’s proposed AI Act entered high-level negotiations this month, generating a renewed interest among medtech stakeholders in this upcoming legislation and its impact on the sector.

Top Stories EU

On 14 June, the European Parliament adopted a draft mandate on the proposed Artificial Intelligence (AI) Act that will form the basis of its negotiations with the European Council and European Commission, known as trilogue discussions. The end result of these negotiations, which could conclude by spring 2024, will be a finalized version of the much-debated cross-sectoral regulation.

This news in itself was one of the top 10 most read articles among Medtech Insight subscribers in June,

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More from Europe

Faster Device Certification Among Keys To Unlocking Innovation In EU MedTech Sector

 
• By Amanda Maxwell

While MedTech Europe sharpens its focus on what the EU most urgently needs to advance the medtech market in four targeted measures, the European Commission has also unveiled four priorities for 2025.

Consumer Healthtech Investment Totaled $4.5BN In 2024, But Bar Is High Amid Economic Uncertainty

 
• By Marion Webb

Global investment in consumer healthtech increased by 9% year-over-year in 2024, totaling $4.5bn, with significant interest in mental health solutions, according to Galen Growth. While the first quarter of 2025 saw raised confidence and investments, the Trump administration’s new tariffs and sweeping changes to healthcare have introduced new uncertainties.

MedTech Europe’s Bisazza Urges Action As US Tariffs Jeopardize Critical Global Supply Chains

 
• By Amanda Maxwell

The intricate assembly of medical devices, often involving over 1,000 globally sourced components, faces severe disruption due to new US tariffs. These barriers could halt production and devastate small and medium-sized enterprises (SMEs), MedTech Europe’s CEO, Oliver Bisazza, warns in an interview with Medtech Insight.

Don’t Sleep On Inspections: Experts Warn FDA Maintains Enforcement Resources

 
• By Brian Bossetta

Manufacturers of medical products would be foolish to think that recent upheavals at the US FDA will result in a lack of inspections in the coming years. A panel of experts discussed the current state of inspections during a webinar hosted by the Food and Drug Law Institute.

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