Module 19: Regulation of In Vitro Diagnostic Medical Devices

13/04/2023

What is published? Published experience gained

• What is issued (printed or otherwise reproduced textual material etc.) for sale or distribution to the public • The work of that is issued publicly • What is submitted (content) online, (e.g. laboratory/hospital intranet) • What is announced formally or officially; proclaimed; promulgated • What can be accessed upon request (e.g. internal document)

Any published item should be authored (identifiable source) and cover the intended purpose.

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Key considerations Published experience gained

• Reports or collations of data used must contain sufficient information to allow rational and objective assessment of the clinical performance of the device

• Reports not adequately supported by data, such as anecdotal reports or opinion, should not be used

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