FDA considerations for GenAI-enabled medical devices
On 18 August 2026, the FDA’s CDRH published “Considerations for the Regulation of Generative AI-Enabled Medical Devices”, a discussion paper…
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MedTech news roundup Summer 2026
Our Summer 2026 MedTech news roundup covers a new MDCG position paper on UDI assignment between manufacturers and distributors, and…
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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 June 2026
Brought to you by our Head of Regulatory Richie Christian, our June 2026 MedTech news roundup covers the latest on…
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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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MedTech news roundup April 2026
Our MedTech news for April 2026 covers updates on device classification and the expansion of WET devices under the EU…
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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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