Module 19 2021

01/06/2021

Standards

Standards have a critical role in the advancement of technologies 1 , in regulation and in regulatory harmonisation efforts 2 Although regulatory processes among regions differ, most Regulatory Authorities share the common objectives to ensure IVD safety and performance and to protect public health. International consensus standards are based upon science, technology and experience and generally reflect the best experience of industry, researchers, consumers, regulators and other experts worldwide.

1 New York Times Feb 16 2019 “The Joy of Standards” 2 IMDRF/Standards WG/N51 FINAL:2018 “Optimizing Standards for Regulatory Use”

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Standards

Role of standards in regulatory processes Reliance upon consensus standards is a key element of a robust regulatory framework. Appropriate use of standards will promote efficiencies and innovation while facilitating objective assessment of device safety and performance. IMDRF encourages the use of appropriate consensus standards in regulatory regimes and recommends that all RAs assess standards and publish a list of recognized or approved standards

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