Module 17 2024

27/11/2024

The Role of the RA Professional

Specific Roles in the UK

• The UK Responsible Person

• Qualified Person (future)

The Organisation for Professionals in Regulatory Affairs

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The Role of the RA Professional

The UK Responsible Person

” a person established in any part of the United Kingdom who acts on behalf of a manufacturer established outside the United Kingdom in relation to specified tasks with regard to the manufacturer's obligations under these regulations”

• Only required for manufacturers located outside the UK

• Manufacturer must appoint a UKRP in writing

• Appears on labelling of UKCA marked devices

• Responsible for registering devices with the MHRA

The Organisation for Professionals in Regulatory Affairs

Lecture 1

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