If you’re selling a digital health product or app into the UK market, you’ll need to decide whether or not it constitutes a Medical Device. Medical Devices require a CE or UKCA Mark and obtaining this can involve business change and investment. But if you fail to comply, this can have serious (including criminal) implications.

Working out whether a software product is a Medical Device can be complex for a number of reasons:

• The definition of a Medical Device and the associated guidance is not specific to software and can therefore be difficult to interpret
• Innovation in digital health often moves faster than the regulators
• The rules can be open to interpretation
• Tiny changes in product functionality or the manner in which a product is described can alter the regulatory position
• The law itself has changed in 2021 in both the UK and EU, especially for software products

Ultimately, every digital health product is a special case and needs to be evaluated on its own merits. We can help you come to a justified decision and, if your product requires it, obtain the necessary CE/UKCA Mark.

Safehand specialises in advising digital health companies on their compliance strategy. To book a one-day Discovery Session, contact us.