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Medical Devices – Latest News
Let’s meet at MEDICA-COMPAMED 2025
Let's meet at MEDICA-COMPAMED 2025 in Dusseldorf from 17-20 November
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Updated Manual on Borderline and Classification for Medical Devices Released
The fourth version of the 'Manual on Borderline and Classification for Medical Devices...
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Future restrictions on PFAS and current regulatory activities from FDA and EU REACH
PFAS in medical devices, typically large-molecule materials known as fluoropolymers, garnered significant public...
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MDCG and AIB release guidance on interplay between EU MDR/IVDR and AI Act
MDCG 2025-6 and AIB 2025-1, released on June 19, 2025, and setting out...
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European Commission releases updated MDCG 2019-11 guidance on software qualification and classification under MDR and IVDR
EU updates MDCG 2019-11 guidance on qualification and classification of medical device software
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