I'd like to know if we need, for the certification puroposes, a filled device classification map (questionnaire) or if the result of classification is enough? In order words, is the chosen MD class enough or we need to show how we got to the specific MDR/IVDR class?
To clarify bit more: we used an online software to classify the MD. We got the result, but not the path with questions and answers.
Thank you,
L.
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ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more 
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
There are no direct requirements that some kind of checklist is supposed to be used for classification. However, just a statement that your device is a certain classification according to some rule is again not enough. You need to elaborate on why your device can fall to a certain rule. For example, devices like sterile gauze for wound management are class I s, under Rule 4 so classification justification will be:
These are non-invasive devices that come into contact with injured skin or mucous membranes can be used as a mechanical barrier, for compression, or for absorption of exudates. According to Rule 4, those devices are class I, but since they are sterile that they are class Is.
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Nov 08, 2022