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Strategy to assess if the change is a significant change

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Guest user Created:   Sep 14, 2020 Last commented:   Sep 15, 2020

Strategy to assess if the change is a significant change

Could you tell me what the strategy is to assess if the change is a significant change?  Perhaps I’m not searching using the correct wording.  Any chances that the documentation would refer to the “NBOG’s Best Practice Guide 2014-3 Guidance for manufacturers and Notified Bodies on reporting of Design Changes and Changes of the Quality System”?

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ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Kristina Zvonar Brkić Sep 15, 2020

When you have significant change for your medical device, you are obliged to report it to your Notify Body according to the guidelines from the practice guide that you have mentioned. Each Notify Body has its own templates for reporting the changes so you will need to fulfill them. Than the Notify body will decide, depending on the significance of the change, is additional audit necessary or not.

In our documentation toolkit, we do not have that template for reporting the change since it is Notify body form. 

Since we are talking here about the change of the medical device, then definitively you will have a change in your technical documentation (medical device file). Document change management is described in the procedure 00_Procedure_for_Document_and_Record_Control_Premium_EN, in section 3.5 Document updates and changes.

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Sep 14, 2020

Sep 15, 2020