Software Apps as Medical Devices: The Regulatory Landscape

Innovative software applications have revolutionized the medical device industry over the last few years. With the growth of mobile and tablet adoption, there are now apps available that contribute to the treatment of diabetes, to facilitate the transfer of lab results for display at nursing stations, and even to help detect cognitive disorders.

With the recentness of these new technologies within the healthcare sector, there is still much confusion over how to deal with them for regulatory purposes.

This whitepaper provides advice to help developers remain compliant and navigate their way through the regulatory landscape. It discusses important considerations for app developers including:

  • When is software considered a medical device?
  • How to classify apps under the Medical Devices Directive?
  • What is needed for a Product Technical File?
  • Is a Software Lifecycle Management process required?
  • What are the differences between European and United States regulatory requirements?