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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…
Congenius
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…
Congenius
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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