This application helps determine if a piece of software qualifies as a medical device under UK MHRA regulations. It provides a guided questionnaire based on the official MHRA flowchart and offers detailed explanations for the classification results.
- Guided Questionnaire: An interactive form that walks users through the MHRA's decision-making flowchart.
- Instant Classification: Get an immediate conclusion on whether your software is a medical device, an IVD, an accessory, or not a medical device at all.
- Detailed Explanations: Understand the reasoning behind the classification with clear, referenced explanations.
- In-Depth Guidance: An extensive, built-in library of regulatory guidance, broken down into easily navigable topics.
- Official Resources: Quick links to download the official MHRA PDF and access public registries for the UK, US, and EU.
- Framework: Next.js (with App Router)
- Language: TypeScript
- Styling: Tailwind CSS
- UI Components: ShadCN UI
- Logic: The classification engine in
src/lib/mhra-software-classifier.tsis a direct implementation of the MHRA's guidelines.