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Difference between revisions of "Medical devices classification tool draft/"
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| + | [[File:Screenshot 2025-01-28 153306.png|thumb|177x177px]] | ||
| + | '''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/Pages/DesignPageV2.aspx?prevorigin=shell&origin=NeoPortalPage&subpage=design&id=FZD9Qk3eI0KjaLrqyrSJJyG_2PeVuVlHvSZss2grfWZUOEhQWktaRlM0Q0FLSUMyOTBHQVc0U1g0Mi4u&topview=Preview '''Classification Tool'''] = | |
| − | |||
| − | = [https://forms.office.com/Pages/DesignPageV2.aspx?prevorigin=shell&origin=NeoPortalPage&subpage=design&id=FZD9Qk3eI0KjaLrqyrSJJyG_2PeVuVlHvSZss2grfWZUOEhQWktaRlM0Q0FLSUMyOTBHQVc0U1g0Mi4u&topview=Preview '''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 07:31, 12 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)
