Feb 18, 2022 Clinical Trial Regulations in the EU – how will the UK follow? By Kate Burgess The European Medicines Agency has confirmed that the new Clinical Trials Regulation is now in effect as of 31 January 2022. Please see...
Dec 13, 2021 Do medical devices have systematic bias? By Kate Burgess Anna Ward An investigation has been launched by the UK’s Department of Health and Social Care (“DHSC”) with the overall aim of improving healthcare...
Mar 22, 2021 The future regulation of medical devices in the UK under the Medicines and Medical Devices Act 2021 By Kate Burgess Anna Ward The Medicines and Medical Devices Act 2021 (the “MMD Act”) was granted royal assent on 11th February 2021. The MMD Act confers broad...
Feb 22, 2021 EUDAMED: streamlining the registration process between Legacy and Regulation Devices By Kate Burgess The European Commission has published a guidance document aiming to further assist manufacturers with understanding how Legacy Devices...
Feb 16, 2021 An ever-changing landscape - European regulator looks to speed up authorisation process for modified vaccines addressing COVID-19 variants By Kate Burgess At a time where drug makers are taking action to develop modified versions of their vaccines in order to address the evolving variants of...