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European Notified Body Survey: MDR, IVDR Certification Numbers Remain Low
A survey from the European Commission shows that many medical device and in vitro diagnostic (IVD) manufacturers have yet to apply for certification under the Medical Devices Regulation (MDR) or In Vitro Diagnostic Medical Devices Regulation (IVDR).
UK Medical Device Regulators Extend UKCA Transition Plan by One Year
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has officially delayed implementation of planned medical device regulations by 12 months in order to avoid potential supply disruptions and allow more time for preparing necessary systems.