Companies trying to determine whether their product should be classed as a medical device or in vitro diagnostic, or neither, can receive guidance from the European Commission and other stakeholders.
Softwares can provide information for treatments and devices or provide support for healthcare personal.
The Medical Devices guidance outlines six steps to help classify the devices:
- Decision step 1: Determine if a product is software according to the definition in the document
- Decision step 2: If the software is incorporated into a medical device rather than standalone software, it must be considered as part of that medical device in the regulatory process of that device. If it is standalone software, proceed to step 3
- Decision step 3: If the software does not perform an action on data, or performs an action limited to storage, archival, communication, “simple search” or lossless compression (i.e. using a compression procedure that allows the exact reconstruction of the original data) it is not a medical device. Altering the representation of data for embellishment purposes does not make the software a medical device. In other cases, including where the software alters the representation of data for a medical purpose, it could be a medical device
- Decision step 4: Software for the benefit of individual patients is software intended to be used for the evaluation of patient data to support or influence the medical care provided to that patient. Examples of software not considered to be for the benefit of individual patients are those which aggregate population data, provide generic diagnostic or treatment pathways, scientific literature, medical atlases, models and templates as well as software for epidemiologic studies or registers
- Decision step 5: If the manufacturer specifically intends the software to be used for any of the purposes listed in Article 1(2)a of Directive 93/42/EEC, then the software shall be qualified as a device. However, if only a non-medical purpose is intended by the manufacturer, such as invoicing or staff planning, it is not a medical device. Note: A task such as emailing, web or voice messaging, data parsing, word processing, and back-up is by itself not considered as being a medical purpose, according to Directive 93/42/EEC
- Decision step 6: If the software is an accessory to a medical device, it is not a medical device, but it falls under Directive 93/42/EEC. The legal definition of ‘putting into service’ requires that a device is made available to the final user/operator as being ready for use on the Community market. Software made available to the user over the internet (directly or via download) or via in vitro diagnostic commercial services, which is qualified as a medical device, is subject to the medical devices directives