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UK Responsible Person 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:
- Registering the devices with the UK regulatory body for medical devices, the MHRA
- Reviewing and keeping a copy of the technical documentation/technical file, declaration of conformity and any CE certificates.
- Provide responses to and facilitate communication with the MHRA, including arranging access to samples of the devices.
- Inform the manufacturer of complaints and suspected incidents regarding the devices.
Benefits of appointing Insight Regulatory as your UK Responsible Person:
- We have a wealth of experience working with the MHRA so we can communicate with them effectively on your behalf, reducing the risk of the devices being taken off the market inappropriately.
- We have experience providing a European Authorised Representative service through our associated company, Eclipse Medtech Ltd , based in Ireland
- We are a team of medical device regulatory affairs experts, meaning that we can review your technical files efficiently and effectively to demonstrate compliance without suggesting unnecessary changes to documents.
If you would like more information on our UK Responsible Person service, then please contact us
