The first stage is to confirm your product or service is legally classified a Software as a Medical Device (SaMD); the product must first have a stated intended purpose that is medical as defined by the medical Directives. It is sometimes difficult to determine if your software or part (modules) of the software has a medical purpose (borderline purposes); for more information you should consult MEDDEV 2.1/6. If software is an accessory to a medical device, MEDDEV 2.1/6 states, “if the software is an accessory to a medical device, it is not a medical device, but it falls under the MDD 93/42/ EEC.”
As indicated in the MDD, standalone software which has a medical purpose is considered to be an active medical device. Classification depends on the risk to the patient and users. To classify your software fully you will need to review rules 9, 10, 11 and 12 of Annex IX of the MDD and also Annex IX, 2.3: Software which drives a device or influences the use of a device, falls automatically in the same device class.
If you are unsure regarding classification, please come and talk with BSI. The European Commission's guidance MEDDEV 2.1/6 is only applicable to standalone software which it defines as: “Software which is not incorporated in a medical device at the time of its placing on the market or its making available.”
AIMD and IVD Directives
Standalone software shall be classed as an AIMD/ IVD or an accessory to an AIMD/ IVD provided that it meets the definition contained in the relevant Directive.