Feb 20, 2023
MDCG
The article provides an overview of the revised guidance document addressing the classification rules. Table Of Contents The Medical Device Coordination Group (MDCG), an advisory body of the European Commission responsible for the medical devices regulatory framework,...
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Aug 19, 2021
EU MDR/IVDR
The Medical Device Coordination Group (MDCG), an advisory body of the European Commission responsible for medical devices regulations, has published a guidance document dedicated to the performance evaluation of SARS-CoV-2 in vitro diagnostic medical devices. Please...
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May 25, 2021
Australia and Oceania
The Therapeutic Goods Administration (TGA), the Australian regulating authority in the sphere of healthcare products, has published guidelines describing the process of inclusion of medical devices in the national register. The present guidelines describe: The process...
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Apr 21, 2021
Australia and Oceania
The Therapeutic Goods Administration (TGA), the Australian regulating authority in the sphere of medical devices and other healthcare products, has published revised guidelines on clinical evidence for medical devices. The document is intended to provide medical...
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Mar 16, 2021
MHRA
The Medicines and Healthcare products Regulatory Agency (MHRA), the UK regulating authority in the sphere of medical devices, has published updated guidance on in vitro diagnostic (IVD) medical devices intended for point of care use. The initial version of the...
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