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We are a team of medical device regulatory affairs experts with experience providing a European Authorised Representative service.
The United Kingdom (UK) left the European Union (EU) on the 31st January 2020 with the transition period ending on the 31st December 2020. This means that, from the 1st January 2021, manufacturers of medical devices based outside of the UK who want to place a device on the market in Great Britain (England, Scotland and Wales, but not including Northern Ireland) will need to appoint a UK Responsible Person that is based in the UK.
The UK Responsible Person needs to act on behalf of the manufacturer to perform certain duties, such as:
Benefits of appointing Insight Regulatory as your UK Responsible Person:
If you would like more information on our UK Responsible Person service, then please contact us