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Difference between revisions of "Medical devices classification tool draft/"
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'''This tool is intended to assist you with the classification of your medical device by walking through the classification rules found in Schedule 1 of the Medical Devices Regulations.''' | '''This tool is intended to assist you with the classification of your medical device by walking through the classification rules found in Schedule 1 of the Medical Devices Regulations.''' | ||
| − | ='''[https://forms.office.com/r/ | + | ='''[https://forms.office.com/r/A8bxGt061p Classification Tool]'''= |
For additional guidance, explanations and examples of how to apply the classification rules, please refer to the following guidance documents: | For additional guidance, explanations and examples of how to apply the classification rules, please refer to the following guidance documents: | ||
Revision as of 10:47, 18 August 2025
This tool is intended to assist you with the classification of your medical device by walking through the classification rules found in Schedule 1 of the Medical Devices Regulations.
Classification Tool
For additional guidance, explanations and examples of how to apply the classification rules, please refer to the following guidance documents:
- Guidance Document: Guidance on the Risk-based Classification System for Non-In Vitro Diagnostic Devices (non-IVDDs)
- Guidance Document Software as a Medical Device (SaMD): Definition and Classification
- Guidance Document Software as a Medical Device (SaMD): Classification Examples
- Guidance Document: Guidance for the Risk-based Classification System for In Vitro Diagnostic Devices (IVDDs)
