This guidance will apply from exit day in line with the Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 .
This guidance sets out how medical devices will be regulated in the UK in a no-deal Brexit scenario.
In a no deal scenario the UK’s current participation in the European regulatory network for medical devices would end, and theMHRA would take on the responsibilities for the UK market currently undertaken through the EU system.
This guidance provides further detail on how the UK system would operate, including for:
- getting your device certified
- CE marking your device
- registering your device with the MHRA
These proposals are still subject to parliamentary approval of the changes to the relevant statutory instruments that are required to bring these proposals into law.
This guidance will apply from exit day in line with the Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 .
This notice is meant for guidance only. You should consider whether you need separate professional advice before making specific preparations.