Software as a Medical Device

Helping you understand Software as a Medical Device

BSI Software DevicesThe 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 Standalone 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 your software has a medical purpose (borderline purposes). Refer to the guidance document (MEDDEV 2.1/6) if you require assistance. If your 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.”

If you are unsure regarding classification, please contact our friendly experts on 1300 730 134. 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.”

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.

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.



Why choose BSI for certification?

Many BSI QMS assessors and client managers are medical device life cycle experts. Many of our active medical device and IVD instrument assessors and client managers have significant years of experience auditing medical device software for compliance with IEC 62304. BSI Software Technical Specialists are software life cycle process experts having performed technical visits to client sites and design dossier reviews, assessing any medical devices with software for compliance with the medical device directives for CE marking purposes.

Several of BSI’s QMS assessors have TickIT certification (third-party certified through IRCA) and conduct process-based audits taking into account ISO/IEC 90003:2004, Software and System Engineering Guidelines for the application of ISO 9001 to computer software.


BSI Software expertise

BSI Software expertise