Quality and Regulatory | Ortho Consulting Group

Quality and Regulatory

We are able to act as a UK Responsible Person for manufacturers of orthopaedic and spine products based outside of the UK.  

All medical devices manufactured outside of the UK will require a UK Responsible Person to represent and register their product for sale in the UK market from 1st January 2021.

The UK Responsible Person must be established in the UK and acts on behalf of a manufacturer established outside of the UK, to carry out specified tasks in relation to the manufacturer’s obligations. This includes registering with the MHRA before the device is placed on the UK market.

Only a manufacturer or a designated UK Responsible Person can legally place a device on the UK market.

Our process:

Documentation Check
Registration Check
Audit Support
Vigilance Reporting

Discover more

If you would like to speak to one of our consultants to discuss how we can help meet your requirements to have a UK Responsible Person please contact us below.

contact us today

or email us directly info@orthocg.com

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