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MHRA guidance on new Medical Devices Post-Market Surveillance requirements
The Medicines and Healthcare products Regulatory Agency (MHRA) has published a suite of guidance to help medical device manufacturers...
Feb 1, 20251 min read
New MDCG 2023-4 on Medical Device Software (MDSW) - Hardware combinations: guidance on MDSW intended to work in combination with hardware or hardware components
The Medical Device Coordination Group (MDCG) endorsed a new guidance document, MDCG 2023-4 , on Medical Device Software (MDSW) - Hardware...
Jan 31, 20251 min read
Update of MDCG 2022-11 Position Paper: Notice to manufacturers and notified bodies to ensure timely compliance with MDR and IVDR requirements
The Medical Device Coordination Group (MDCG) endorsed MDCG 2022-11 Rev.1 , an update of the position paper with the notice to...
Jan 31, 20251 min read
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