Declare your Medical Device status

You need to tell us whether you have assessed your product to be a medical device.

If you declare that it is, you need to ensure you comply with the relevant legal requirements.

Help and tips for completing this section

The following resources provide more information about when software applications are considered to be a medical device and how they are regulated:

Q.1

Is your product or service a medical device?
Supporting information

Download the EU standard for Guidance on Qualification and Classification of Software in Regulation.

Q.1.1

Which Medicines and Healthcare products Regulatory Agency (MHRA) classification does your product comply with?
Q.1.2
Supporting information

Review the Medicines and Healthcare products Regulatory Agency (MHRA) interactive guidance.

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