Device classification

Touchdose is a software-only, stand-alone active medical device. It is classified as a Class I active medical device under the classification rules set out in Schedule 9 of the Medical Devices Regulations 2002 (SI 2002/618, as amended) ("UK MDR 2002"), which transpose Annex IX of Council Directive 93/42/EEC into UK law.

Touchdose is placed on the UK market under the UKCA conformity assessment route for Class I devices (self-declaration; no notified or approved body verification required).

The classification rationale is maintained by Dosium and is available on request.

See also the Intended use and Manufacturer information sections.