Software Medical Device Classification



Dear experts,
I'm trying to find a criterion for the classification of Software Medical Device, to implement management procedures (test and maintenance).
In addition to the classical classification in relation to the risk class (Class I, IIa,IIb,III in Europe, and Class A,B,C in USA) does anyone have other references or personal ideas to catalog SW MD?
Thanks in advance for any feedback.


Staff member
Super Moderator
IEC 63204 has class A, B, C as well.

In the US, the FDA has a "level of concern" rating: Minor, Moderate, and Major.


Thanks for feedback. I asked for a different criterion of classification in addition to classical classification related to risk.
For example: functional classification, morphological classification, software connected or disconnected to the network....
Rules and Regulations for Medical Device Update

Medical updates are necessary for a number of reasons. A healthcare setting has to keep giving medical updates to the families of patients that it is treating. A medical update becomes very important for the media when an important person is undergoing treatment. Medical updates are also given out on social media whenever something significant is noticed or discovered that could be of use to society at large.
The effect of software on the safety and performance of medical devices has continued to grow over recent years. This is particularly relevant when the device itself is a software only product.
As a Notified Body, we have world-leading product specialists in the Active Devices, IVD and Active Implantable Medical Devices teams with a wealth of experience gained from device and other regulated industries to understand the complete range of medical device software

Is my Software a Medical Device?

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.

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