Module 19: Regulation of In Vitro Diagnostic Medical Devices

28/03/2023

13

Technical documentation

How should it be compiled?

The Organisation for Professionals in Regulatory Affairs

13

14

How should it be compiled?

‘The technical documentation and, if applicable, the summary thereof to be drawn up by the manufacturer shall be presented in a clear, organised, readily searchable and unambiguous manner* and shall include in particular the elements listed in this Annex.’ (IVDR Annexes II and III)

The Organisation for Professionals in Regulatory Affairs

14