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EC Decision on Standardization for Medical Devices

The European Commission (EC), the medical device regulating authority of the European Union, issued a new regulation regarding standardization aspects in the context of Medical Devices Regulation 2017/745 (MDR) and In Vitro Diagnostic Medical Devices Regulation...

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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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