One great debate that always comes around when auditing Regulatory Affairs as part of your ISO 13485 system relates to change notifications to notified bodies. When exactly do you report a change i.e. when is a change a significant change?
Help is at hand in the EU Association of Notified Bodies give guidance on this issue.
The guidance notes start by recommending that each manufacturer have a (documented) procedure to clarify the reporting procedure for any changes to the design, device and/or quality system as significant or not significant (i.e. to report or not to report).
So to ensure compliance you actually need to check that you have a procedure and the requirements for reporting in that procedure.
What should the procedure say?
The procedure should define what a significant change is and when the change should be communicated to your notified body.
Changes can be categorised into two main types:
1. Product changes, where the change would affect conformity with (i) the essential requirements and/or (ii) the conditions prescribed for the intended use of the device
2. Changes to the quality system, that would (i) affect compliance of the devices covered by the quality system with the essential requirements or the approved type / design or (ii) mean additions to the product range covered by the quality system.
Significant product/device changes…
As a checklist for product changes the procedure should cover the following situations:
• Changes that introduce new hazards which have not been previously addressed
• Changes adversely affect the risk associated with existing hazards
• Changes that alter the details on intended use
• Changes that alter compliance with the essential requirements contained in the technical file
• Changes that the device will have different end users or be used in a different manner
• Changes that mean that the clinical data may not support the new device characteristics and performance
Significant system changes…
The procedure should cover the following situations:
• Changes that alter the manufacturing technologies or product-range covered
• Changes that affect product conformity with the essential requirements
• Changes that affect the continued compliance of the quality system with the relevant harmonized standards
• Changes that affect the arrangements (e.g. verification, validation, organizational
• Structure, change in sub-contractor) for ensuring continued compliance.
Reporting a significant change…
A notification of any substantial should include prompt (or even advanced) notification to your notified body to include:
• A brief description of the modifications compared to the approved design/device or approved quality system
• The reason for the changes / modifications
• in the case of design / device changes, a statement on the relevance to the compliance with the essential requirements.
The procedure referred to may not have to be a stand alone procedure but control of changes must be defined within your quality system.