The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has published guidance on the new rules that will govern the regulation of medical devices and in vitro diagnostic medical devices placed on the market in England, Wales and Scotland after the BREXIT transition period (different rules will apply to Northern Ireland). This On the Subject outlines key dates for implementation of the new rules and certain practical implications of changed regime.
The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has published guidance (the Guidance) on new rules that will govern the regulation of medical devices after the end of the transition period. Whilst some of this guidance is similar to guidance issued as part of the “No deal BREXIT” publications in 2019, the MHRA has also set out proposals to engage and consult on a new medicines and medical devices regulatory framework for the UK.
The UK left the European Union (EU) in January 2020 but is currently in a transition period. The Guidance was released as part of a collection of updates covering various MHRA-regulated sectors (including medicines, clinical trials and licencing procedures) which will also be subject to new rules from 1 January 2021.
This update focuses on the new regulatory framework for medical devices and in vitro diagnostic medical devices (IVDs) placed on the market in England, Wales and Scotland (Great Britain) only. Different rules will apply to Northern Ireland.
Existing law to continue
The rules that currently regulate medical devices and IVDs in the UK (through the Medical Device Regulations 2002) will continue to have effect in Great Britain after the transition period.
Will the new EU Medical Devices Regulation (MDR) and EU In Vitro Diagnostic Medical Devices Regulation (IVDR) apply in the UK—and if so, when?
The MDR and IVDR will fully apply in the EU from 26 May 2021 and 26 May 2022, respectively.
The question as to the application of the MDR in the UK will be of key interest to medical device manufacturers, their supply chain and customers, many of which are working to achieve MDR compliance for EU markets.
The MDR was due to be implemented across the EU and UK from 26 May 2020. However, in early April 2020 the EU Commission proposed a one-year extension of the implementation date to avoid disruption and additional burdens on medical device manufacturers during COVID-19. This delay was approved by the EU Parliament and Council on 23 April 2020 and the new implementation date for the MDR is