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IMDRF Proposed Principles of IVD Classification

The International Medical Device Regulators Forum (IMDRF), an association composed of medical device regulating authorities, proposed new principles of classification of the in vitro diagnostic medical devices. The organization itself is focused on the development and...

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EC Guidance on Medical Devices in the COVID-19 Context

The European Commission (EC), the European authority responsible for medical devices regulation, issued guidance dedicated to medical devices, active implantable medical devices and in vitro diagnostic medical devices in the context of Coronavirus Disease 2019...

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