The current Regulatory scenario for medical devices in the United Kingdom (UK) is governed by the Medical Devices Regulations 2002 (SI 2002 No. 618, as amended), also known as the UK MDR 2002. This framework was originally based on the European Union (EU) Directives, but following the UK’s exit from the EU, there have been changes to how medical devices are regulated in Great Britain (GB), comprising England, Wales, and Scotland.
Here are the key points with respect to the current Regulatory scenario for medical devices in the UK:

As the Brexit deadline is fast approaching, the occurrence of a no-deal Brexit is likely. In this context, the Medicines and Healthcare products Regulatory Agency (MHRA) of the UK has updated its no-deal Brexit guidance on the regulation of medicines, medical devices, and respective clinical trials. According to the update, medical device manufacturers wishing to place a device in the UK market must have a ‘UK Responsible Person’ to register their devices with the MHRA, as similar to the European Union (EU) authorized representative.