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IVDR Update: European MDCG Issues Guidance on Substantial Modification of a Performance Study
An MDCG guidance document explains the process for obtaining permission to conduct a substantial modification of a performance study in European Union member states according to Regulation (EU) 2017/746.
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).