ISO 10993-1 | What’s new in the latest draft standard?
ISO 10993-1 provides the governing foundation for the biological evaluation of medical devices, explaining the fundamental requirements and general principles.…
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MedTech news roundup May 2025
Our May 2025 MedTech news covers the Swiss Federal Council’s guidelines for expanding medical devices supply, an upcoming focus campaign…
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MedTech news roundup April 2025
Our April 2025 MedTech news covers new harmonised standards from the EU Commission, updates from MedTech Europe on IVDR, MDR,…
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MedTech news roundup March 2025
Our March MedTech news covers EU-US trade tensions, the Clean Industrial Deal, updated guidance on IVD classification, and calls for…
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Chemical Analysis for Biocompatibility Assessment of Medical Devices | Essentials from the FDA draft guidance
In September 2024, the FDA published its draft guidance on “Chemical Analysis for Biocompatibility Assessment of Medical Devices” to improve…
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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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