UK Life Sciences and Healthcare Newsletter- December 2020: Regulatory Updates

Regulatory Updates

• Medicines and Medical Devices Bill (MMDB) – The MMDB is intended to act as the primary UK legislation specifying powers that would enable the regulatory regimes for human medicines, clinical trials, veterinary medicines and medical devices to be updated by way of delegated legislation at the end of the EU Exit Transition Period (currently 31 December 2020). A date is yet to be announced for the bill to enter the Report stage in the House of Lords.
• Medicines and Healthcare products Regulatory Agency (MHRA) Brexit Update – On 1 September 2020, MHRA published new guidance on the regulation of medical devices in the UK. From 1 January 2021, manufacturers or suppliers of medical devices to the UK will need to register their devices with the MHRA. After 30 June 2023, manufacturers and suppliers must have obtained the UK conformity assessment and UK Conformity Assessed (UKCA) mark for medical devices marketed in the UK.