DigitalHealth.London can assist with and provide feedback on the development of commercialisation and route to market models.
Knowing the regulatory route to market is key to successful commercialisation. Some digital health products, such as apps, may be classified as medical devices by the Medicine and Healthcare products Regulatory Agency (MHRA). More guidance on this can be found here. Most however, will fall under a ‘low risk’ category, so a self-certified/ self-declaration CE mark is possible. A CE mark is a key indicator (but not proof of) a products compliance with EU legislation. It is a good idea to approach MHRA early and talk to them if unsure whether a product is a medical device: Devices.Regulatory@mhra.gsi.gov.uk.
- When developing new products, it may be useful to refer to the British Standards Institution (BSI) Health and wellness apps. Quality criteria across the life cycle. Code of practice.
- There is not a single app-approval process, but it may be useful to consider some existing evaluation processes:
- In order to meet the standards required to handle care information, visit NHS Digital’s Information Governance (IG) page. Engage with IG teams and requirements early.
- If you want to supply to the NHS, the London Procurement Partnership (LPP) can act as a bridge between customer and supplier. Engage with Procurement teams and ask questions early if setting up a trial i.e. at what point do the trust need to be going out to market?
c/o: Health Innovation Network
5 Montague Close