UK Responsible Person Service

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 Mosaic Surgical is providing UK Responsible Person Service to manufacturers of medical devices who wish to continue to supply the UK market once the UK has fully departed the EU regulatory structure on 31 December 2020.  This means that Mosaic Surgical would act on behalf of the manufacturer for relations with the regulating authority in the UK. 

The UK has left the European Union with a trade deal that requires non-UK manufacturers to appoint a UK Responsible Person for their medical devices, Mosaic Surgical offer a UK Responsible Person service, that allows us to register your products with the MHRA (MHRA Account no. 11356) on your behalf.
Mosaic Surgical understand that it is vitally important that non-UK based companies retain access to the UK market. We have made the necessary arrangements to align with stated requests from the MHRA.
The amended UK Medical Devices Regulations 2002 (SI 2002 No 618) (UK MDR 2002) which governs medical devices in the UK, will include these extra registration requirements.Our UK responsible Person Scheme is headed by our Medical Device Expert, Head of QA/RA Heather Pendlebury. We have long experience in the field of regulations regarding medical devices and are at the forefront of regulatory compliance post-Brexit. 

• Access to individuals with expert knowledge in regulatory compliance.
• Registration using Mosaic Surgical as your responsible person.
• Vigilance tracking and reporting including communication with relevant interested      parties.
• Maintaining document files for questions arising from the MHRA.
• General regulatory correspondence in the UK as required.

This service conforms fully with the requirements of the MHRA guidance. 

• Annual fixed fee including set up and maintenance incl 3 hours
• Additional services offered on an ad hoc basis as needed

  https://www.gov.uk/guidance/regulating-medical-devices-in-the-uk#responsible