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Is Your Software a Medical Device?

Good question. The answer is, ‘It depends’. It depends on the ‘Intended Use’ of the software, the criticality of the application, and the resulting classification given all the facts of its use. Implied  in this is the intention of the manufacturer who created and marketed the software. Therefore, a proper assessment of the software should be completed to ensure that the software follows the correct path to compliance. This may include development and qualification to the harmonized IEC 62304 software development lifecycle standard.

Currently, the definition of software as a medical device per the Directive 93/42 (European Medical Device Directive or MEDDEV) is being challenged in at least one case in the European Union. Even though this case ruling, when rendered, will apply to a specific medical software application, it could have wide ranging implications to the medical software application industry.

Here are the MEDDEV guidance documents on software that can be helpful in the process of determining if the software is a medical device:

MEDDEV 2.4/1 rev.9 Classification of medical devices – June 2010

MEDDEV 2.1/6 Qualification and Classification of stand alone software – July 2016

MEDDEV 2.1/1 Definitions of “medical devices”, “accessory” and “manufacturer” – April 1994

One additional resource for software is the MHRA Guidance on medical device stand-alone software (including apps) & IVDMD, last updated in September 2016:

Also, there are several documents by the International Medical Device Regulators Forum (IMDRF), specifically addressing “Software as a Medical Device” (SaMD). The following three IMDRF documents may also be helpful:

IMDRF – Software as a Medical Device (SaMD): Key Definitions:

IMDRF – Software as a Medical Device (SaMD): Possible Framework for Risk Categorization and Corresponding Considerations:

IMDRF – Software as a Medical Device (SaMD): Application of Quality Management System:

For help in navigating though the compliance pathway, including IEC 62304 guidance, qualification, and Verification & Validation of your software based product, contact The Realtime Group at 972-985-9100 or