Significant Change Analysis Checklist

Date:

1. Nature of Change:

2. Reference Documents:

3. Risk Analysis (as per below Questionnaire):

Questionnaire used for identifying significant changes (Given in Technical
Construction File.
For the changes in design, does the change :
a) introduce new hazards which have not been previously addressed?
b) adversely affect the risk associated with existing hazards?
c) Alter the classification of the device?
d) alter the details on intended use and/or compliance with the essential
requirements given in the Device Master Record submitted to the Notified
Body and/or health Canada (MDR) ?
e) mean that the device will have different end users or be used in a different
manner or for a different purpose?
f)

mean that the clinical data for the original device is not sufficient to confirm
conformity of the changed device with the required characteristics and
performance?

Form No.:
Issue No:

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For changes to the quality system the matters that are considered when deciding
whether or not particular changes are substantial include the following. Does the
change:
a) alter the manufacturing technologies?
b) affect product conformity route?
c) affect the continued compliance of the quality system with the relevant
harmonised standards against which it has been approved?
d) affect the arrangements for ensuring continued compliance with the
requirements of the Directive for example verification, validation etc.?
e) require that manufacturing processes and controls are re-validated?

4. Conclusion:
1. As analyzed above, does this change fall in to the category of significant
change ?

2. As analyzed above, does this change fall in to the category of product or

process change?

3. Does this change warrant any Biocompatibility testing, as the material

remains same?

4. Is there any change in electronics and does this warrant any additional safety
testing?

5. Does the device continue to comply with the essential requirements of the
directive MDD 93/42/EEC or any essential requirements need to be updated?

6. List QMS Documents that are updated and added.

Form No.:
Issue No:

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7. Other remarks, if any.

Form No.:
Issue No:

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