Module 19 2021

24/05/2021

Comment on format of technical documentation

‘clear, organised, readily searchable …’ Whilst the wording of Annexes II and III don’t specifically exclude use of paper formats it could be interpreted to mean that electronic formats should be used

The Organisation for Professionals in Regulatory Affairs

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How should it be compiled?

• How closely should summary technical documentation follow the order and content of IVDR Annexes II and III? • Will notified bodies expect a high level of concordance to make it easier to assess compliance (check-box approach)?

The Organisation for Professionals in Regulatory Affairs

22

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