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EC Amends Notified Bodies Designation Procedure

The European Commission (EC), the EU body responsible for medical devices regulatory framework, announces amendments to the designation procedures related to the Notified Bodies (NBs), and also to the rules on the EU-wide derogations. EC New Regulations in Brief Both...

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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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