Is my software product a Medical Device?

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 Mark and obtaining this can involve business change and investment. But if you fail to CE Mark a software product which should be a Medical Device, this can have serious (including criminal) implications.

Working out whether an app or web-based 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 is changing in the move from the Medical Device Directive to the Medical Device Regulation

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 Mark.

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