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MHRA Response to the IMMDS Review Europe

MHRA Response to the IMMDS Review

The Medical and Healthcare products Regulating Authority (MHRA) has published a response to the report of the Independent medicines and medical devices safety (IMMDS) review. Report on Safety Review in Brief The review is based on the principle stating that the...

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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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MHRA Guidance on Field Safety Notices MHRA

MHRA Guidance on Field Safety Notices

The Medicines and Healthcare products Regulatory Agency (MHRA), UK’s authority responsible for the regulation of medical devices, issued guidance on field safety notices (FSNs). The document is intended to assist medical device manufacturers in preparing the...

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