EN 18286 | What’s new & what’s the impact?
Last month (July 2026), CEN & CENELEC published the European Standard EN 18286, which defines a QMS specifically to meet…
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MDR 2.0 & EU AI Act | Implications for AI in MedTech
The Commission’s proposal COM (2025) 1023 final (widely known as MDR 2.0) aims to simplify and streamline the MDR by…
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MedTech news roundup May 2026
Our MedTech news for May 2026 covers the new implementing rules from the EU Commission, MedTech Europe’s call for regulatory…
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AI Index Report 2026 | Key takeaways
The ninth edition of the AI Index Report has been released – and for the first time, it features standalone…
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AI, ML, & Medical Devices | A comprehensive overview
Artificial Intelligence (AI) and Machine Learning (ML) in medical devices are reshaping disease prevention, diagnosis, and management. The technologies enable…
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The AI Act | An updated overview
As mentioned in last week’s article – The Data Act’s relevance in 2026, back in 2024, the EU regulatory environment…
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MedTech news roundup June 2025
Our June 2025 MedTech news covers the recent guidance from the MDCG on the interplay between the MDR/IVDR and the…
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MedTech news roundup February 2025
Our February MedTech news covers calls from the European MedTech industry for the EU to become a full member of…
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