Are COTS products Medical Devices?

COTS products (Commercial Off The Shelf) that are developed for general commercial use and are not specific to health care such as database applications, encryption applications, and web portal applications, are not considered medical devices, even when they are integrated into health information systems and infrastructures that process personal health information.

However, where COTS products such as databases and portals are integrated into a patient management software product that is classed as a Class II device, the patient management software manufacturer must verify and validate that the COTS product has been safely and effectively configured and integrated into the patient management software product.

[Note: This answer was reviewed by Health Canada]