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Medical Devices – Latest News
Public consultation launched: EU Commission seeks feedback on reform of MDR and IVDR
The EC launched a public consultation on the reform of the MDR and...
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MDCG publishes new guideline on post-market surveillance
MDCG publishes MDCG 2025-10 guideline on post-market surveillance for medical devices and in...
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MDCG releases guidance on breakthrough devices
MDCG releases guidance on breakthrough devices aims to support the development, conformity assessment,...
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EUDAMED: First four modules confirmed operational
On 27 November 2025, the EC published Decision (EU) 2025/2371, confirming the functionality...
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New ISO 10993-1:2025 Standard for Medical Device Biological Evaluation Released
New MD biocompatibility standard, ISO 10993-1:2025, helps manufacturers identify, assess, and manage biological...
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