Module 15 2022

5/19/2022

The New UK Regulatory System

UKCA

The UK Responsible Person • Required for manufacturers located outside the UK • Appears on labelling of UKCA marked devices • A manufacturer can only appoint 1 UK Responsible Person • Responsibilities include:

• Registration of devices • Ensure DoC and technical file drawn up • Provide information/device samples to MHRA on request • Cooperate with MHRA on CAPAs • Inform manufacturer about complaints/suspected incidents • terminate the relationship if the manufacturer acts contrary to their obligations

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© NAMSA 2021

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The New UK Regulatory System

UKCA

Work in Progress:

• UK Approved Bodies – three so far (BSI, SGS and UL) • Development of the new regulatory system:

• Independent expert panel commissioned

• Consultation process

• New secondary legislation spring 2022

• The Cumberlege Report (July 2020)

• Delivery plan 2021-2023

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© NAMSA 2021

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