Medical Devices Risk Classification Tool
The Medical Device Risk Classification Tool is a query tool to help you identify the risk classification of a medical device. It is designed in accordance to the risk classification rules of GN-13 Guidance on the Risk Classification of General Medical Devices and GN-14 Guidance on the Risk Classification of In Vitro Diagnostic Medical Devices.
You are advised to verify the risk classification results derived from this tool with the product owner of the medical device. However, if in doubt, you may contact the Medical Device Branch for further clarification.
If, based on the product owner's intended purpose, two or more risk classifications rules apply to the medical device, the medical device is allocated the highest level of risk classification indicated.
This classification tool may take you 10 minutes to complete.
Medical Device Classification
To begin, please select the type of medical device below
From the information provided, your device is classified as
No risk classification can be provided based on your selections. Please verify your previous selections.
Alternatively, you may click "Restart" to try again.
NOTE: When using the risk classification tool for IVD medical devices, Question 17 would refer to IVD analysers that are not intended for use in specific medical diagnostic purposes. Example: sample-preparation instruments
The above classification tool is intended to provide general guidance only. Although we have tried to ensure that the information contained here is accurate, we do not, however, warrant its accuracy or completeness. The Health Sciences Authority (HSA) accepts no liability for any errors or omissions in this tool, or for any action/decision taken or not taken as a result of using this tool. The information contained in this logic tool should not be a substitute for professional advice from your own professional and healthcare advisors.