Module 17 2024

05/12/2024

The UK Regulatory System (UKCA)

Presented by:

Kevin Butcher: Principal Regulatory Consultant - NAMSA

Date: 5 th December 2024

The Organisation for Professionals in Regulatory Affairs

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Introduction to UKCA - Now

The UK left the EU on December 31st 2020, and therefore no longer covered by EU Regulations [MDR/MDD/AIMD or IVDR/IVDD]

New UK Regulation [UKCA – UK Conformity Assessed] came into operation on the 1 st January 2021 and will be fully implemented by July 2025* The UK Medical Devices Regulatory Authority: MHRA [Medical and Healthcare Regulatory Authority] are implementing a transition period between these two dates

The Organisation for Professionals in Regulatory Affairs

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