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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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 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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MedTech news roundup June 2024
Our MedTech news roundup for June 2024 includes the latest on Swissdamed, a fact sheet from MedTech Europe on new…
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A Regulatory Guide to Post-Market Surveillance
Post-Market Surveillance (PMS) according to MDR 2017/745 and IVDR 2017/746 is a systematic process to continuously monitor the safety and…
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MedTech news roundup May 2024
Our MedTech news roundup for May 2024 spans a new combined studies project from the EU Commission, new guidance from…
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MedTech news roundup April 2024
Our April 2024 MedTech news roundup covers an update from Swissmedic on medical device software, guidance from the MDCG regarding…
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