# 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 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](/content/contact/index.html).

# How can we help?

For more information about our digital health compliance services get in touch by calling us or using our online enquiry form.

[+44 (0)114 4000455](tel:+441144000455)

[ENquire Online](/content/contact/index.html)