The Medicines and Healthcare products Regulatory Agency (MHRA) has published new guidance on GOV.UK, which sets out how medical devices will be regulated after the transition period with the EU has ended (from 1 January 2021).
Key takeaways and learning objectives
- The introduction of the new UK route to market and the mark of conformity for devices.
- The transition period for products already CE marked, following confirmation of recognition of the CE mark until 30 June 2023.
- The implications of Great Britain not implementing the EU Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR).
- Outline of how the requirements will impact manufacturers in the UK and EU.
Join BSI’s Dr Jayanth Katta, Senior Regulatory Lead, to hear the Notified Body perspective on the announcement regarding the new UK Conformity Assessed (UKCA) mark.