Change management under the MDR   

The MDR transition period started on 26 May and new regulatory requirements now apply. According to MDR Art. 120 (3), significant changes to the design or intended purpose of devices certified under the Directives are now restricted. Changes that are not correctly categorised can result in discontinuation of a product under MDD.  

In light of this, a superior change management system is crucial for the transition period, in order to give manufacturers the possibility to fully access their product portfolio under the Directives and facilitate transition to the new Regulation.  

This presentation provides guidance for manufacturers over how to establish a compliant change management system under the new Regulation. It further covers the regulatory framework and the Notified Body´s expectations concerning submission of significant changes.


Date and time: Monday, 8 November 2021, 6.30 pm (CET)

Your speaker: Dr Michael Binder | Team Lead Center of Cardiovascular Excellence and Process Owner Change Management

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