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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MedTech news roundup January 2025
Our MedTech news roundup for January 2025 covers the amended IvDO, MedTech Europe’s 2024 Regulatory Survey results, the latest endorsement…
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MedTech news roundup November 2024
Our MedTech news for November 2024 covers MedTech Europe’s recommendations for EU Green Deal implementation, MDCG guidance on the regulatory…
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Artificial intelligence, machine learning & medical devices | 5 ways to mitigate knowledge gaps
Medical devices containing artificial intelligence (AI) or machine learning (ML) still pose significant challenges for regulatory authorities and manufacturers alike,…
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How the AI Act, NIS 2, & Data Act will impact the EU medical devices regulatory landscape
Between August this year and September next year the regulatory environment in the EU regarding data will become more complex,…
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