Technical Documentation under the IVDR

The In-Vitro Diagnostic Regulation 2017/746 updates the legal framework for all in-vitro diagnostic medical devices intended to be placed on the European Single Market. In addition to several new requirements, Annexes II and III of the IVDR provide a detailed list of requirements for complete Technical Documentation. Technical Documentation is required for all IVDs irrespective of their individual risk class.

This webinar informs about the key elements of Technical Documentation and provides valuable insight into the approach applied by Notified Bodies to the review of Technical Documentation. Technical Documentation that is well organised, easily searchable and clear supports quick market access – including under the IVDR - and reduces problems in the conformity assessment process.

Date and time: Thursday, 5 November 2020, 04:30 pm (CET)

Your speaker: Marta Carnielli, IVD Technical Officer


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