MedTech news roundup October 2024
Our MedTech news for October 2024 covers the EU Parliament resolution on MDR revision, MDCG guidance on IVD qualification and…
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PFAS in medical devices
Per- and polyfluoroalkyl substances (PFAS) are set to be increasingly regulated in the EU. In our 5-minute guide below, our…
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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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MedTech news roundup September 2024
Our MedTech news for September 2024 covers new procedures from Swissmedic for submitting clinical trials applications, the latest from EMA…
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Clinical evaluation under MDR | Determining adequate clinical evidence
The introduction of MDR has significantly increased the importance of clinical evaluation for medical devices. And whilst several guidelines exist…
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MedTech news roundup August 2024
Our MedTech news roundup for August 2024 includes the latest from Swissmedic on EU IVDR equivalence and Swissdamed respectively, and…
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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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MedTech news roundup July 2024
Our MedTech news roundup for July 2024 covers WHO’s announcement of MeDevIS, the EU AI Act, MDCG guidance on medical…
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