Technical Documentation under the MDR  

Medical Device Regulation 2017/745 updates the legal framework for all medical devices intended to be placed on the European Single Market. In addition to several new requirements, the MDR includes detailed lists of requirements for complete Technical Documentation in Annexes II and III. Technical Documentation is required for all medical devices independent of their individual risk classes.

This webinar provides information about the key elements of Technical Documentation, with a valuable insight into the approach of a Notified Body towards reviewing Technical Documentation. Well-organised and clear Technical Documentation will support quick market access – including under the MDR – and reduce problems in the conformity assessment procedure, thereby enabling stakeholders to focus on issues of real importance.

Date and time: Wednesday, 4 November 2020, 4:30 pm (CET)

Your speaker: Martin Witte, Senior Director Strategic Business Development


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