Module 17 2024

05/12/2024

Chapter 14: Alternative Routes to Market

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On 14 November 2024, the MHRA issued a further consultation process on the UK Medical Device Regulations entitled “Routes to market and in vitro diagnostic devices”. This consultation process will end on 05 January 2025. The consultation covered four areas: • UKCA Marking • International Reliance • IVDs • Assimilated EU Law. The area concerning International Reliance covers alternative routes to the market. One minor change is from International Recognition to International Reliance. The rationale for this name change is that “Recognition” is the acceptance of the regulatory decision of another regulator, whereas “Reliance” is the act whereby the regulatory authority in one jurisdiction takes into account and gives significant weight to assessments performed by another regulatory authority Chapter 14: Alternative Routes to Market

The Organisation for Professionals in Regulatory Affairs

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