U.K., Sept. 24 -- The guidance below outlines the steps that you need to follow to meet the legal requirements before your product can be released into the UK market.
The first step that you need to take is to determine if your product is actually a medical device, by definition a medical device is any physical instrument, appliance, apparatus, material, software or other article that is used alone or combined for people to diagnose, prevent, monitor and/or treat a disease, diagnose, monitor, treat, alleviate or compensate for injury or handicap, control conception or finally to investigate replace and/or modify the anatomy or a physiological process. If you are manufacturing anything that meets this definition, you must follow specific ru...