UK Medical Device Registration Overview

Post-Brexit, the UK is still altering and adding its regulations for medical devices. The regulations to be followed in the country are bifurcated geographically – Great Britain (GB) and Northern Ireland (NI). Medicines and Healthcare Products Regulatory Agency (MHRA) is the regulatory authority that looks after medical device. Northern Ireland is required to comply with European Union Medical Devices Regulations (EU MDR) 2017/745 and In Vitro Diagnostic Devices Regulations (IVDR) 2017/746. Non-UK manufacturers must appoint a UK Responsible Person (UK RP) to help them comply with these regulations and ensure a successful UK Medical Device Registration process.