Knowing the regulatory route to market is key to successful commercialisation. For example, some igital health products 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 product’s compliance with EU legislation.
Through its expertise in business support, DigitalHealth.London can assist with, and provide feedback on commercialisation and development. This is provided through our Accelerator programme, as well as bespoke consultancy services. Find out more by emailing email@example.com.
- When developing new products, it may be useful to refer to the British Standards Institution for advice on health and wellness apps.
- 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?