Nav.AI: a cognitive assisted digital regulatory navigation platform for health product innovators

Products designed for use in the health sector cover a very wide range of form and function. Products designed for use in this sector may have a medical function which makes the product either a medicinal product or a medical device product or they may fall outside the product classification requirements. The regulations, standards and guidance which govern the sector are complex and present a maze which developers find difficult to navigate. A product developer must navigate this regulatory maze and meet the regulatory requirements before a product can be sold.

NAV.AI aims to develop a cognitively assisted platform to guide a user through the maze of regulations for health related products and on the basis answers to questions about

* What the product is designed to achieve
* How the product achieves its goal
* The claims the developer wishes to make for the product
* Publicly available data regarding medical device, medicinal compound and disease classification

identify the most appropriate classification for the product i.e. is it a medical device (Medical Device, IVD or active implantable medical device) or some other form of regulated product? The platform will also identify any other regulations which the product must comply with. Once the platform has determined the type of product it will then determine the options available for obtaining a UKCA and/or a EU CE mark required to sell the product.

The project is innovative since the compliance software available that is designed for use in the health products industry, are designed to help the user maintain regulatory compliance and not identify the regulations which a product should comply with. This platform aims to provide product developers with a road map for how to demonstrate the compliance of their product with the relevant regulations, standards and the resources available to help them achieve it.

Since the aim of NAV.AI is a proof of principle, a smaller subset of regulations will be considered. The platform will be tested using product details and judged against its ability to correctly identify the applicable regulations standards etc, which the product must comply with and the support available to meet those requirements.