Do you need CE or UKCA marking for medical software?

Yes, you need either CE or UKCA marking, depending on your market. CE marking applies to the EU and European Economic Area; UKCA marking is required for the UK market since it left the European Union [#272][#341].

The specific classification depends on your software's intended use and risk level. Medical software typically falls under medical device regulation, and you'll need to comply with the relevant standards, notably ISO 13485 and the Medical Device Regulation (MDR) in Europe [#341]. The process is demanding: expect significant time, cost, and focused effort, particularly if you're pursuing both certifications simultaneously [#341].

One critical detail: if your software isn't CE or UKCA marked but processes medical images or clinical data, clinicians using it off-license assume personal liability for any patient harm [#265]. Transparency about your regulatory status matters for clinical adoption and trust [#399].