Validation of software classified as medical device

28. February 2020

Digitalisation now influences almost all areas of our lives – including our health. The so-called mHealth (mobile healthcare) apps play an important role in this. mHealth apps are applications that aim to positively and sustainably influence physical, mental and social well-being based on scientific findings.
Recently, the number of health apps was estimated at over 380,000 – and the trend is rising. This trend can be explained on the one hand by the fact that almost everyone owns a Smartphone or Tablet PC, and on the other hand because mHealth is an area that has the potential to improve the quality and efficiency of our lifestyle and revolutionise the healthcare system. But what many people don’t know is that some of these apps carry great risks and dangers – not least because of the lack of quality and validation standards. Such apps are called medical apps. These are applications that have their mission in the prevention, diagnosis and therapy of diseases and injuries. They are regarded as medical products and are therefore subject to strict legal requirements.

An app is considered to be a medical device if it meets the definition of such a device in the sense of the new European Medical Device Regulation (MDR) 2017/745 dated 5 April 2017. Definitions are usually generic so that they apply to many products.

The decision as to whether an app is classified as a medical device and thus the responsibility for the safety of the software lies solely with the manufacturer. This definition – whether a medical device or not – is defined by the manufacturer in the purpose written by him. Up to now, app developers have been able to easily circumvent the strict regulations regarding the safety and effectiveness of medical devices by simply referring to them as health or fitness apps in the product description. To close this legal gap, the FDA has published a document (“Mobile Medical Application- Guidance for Industry and Food and Drug Administration Staff”) in 2013, which explains which apps are to be classified as medical apps.

To improve safety and health, a new medical device regulation (MDR 2017/745) was adopted in Europe in April 2017. Unfortunately, it is still not trivial to find out whether a certain app is a medical device or not. With our more than 20 years of experience in the regulated environment, we would be happy to advise you on this issue and to examine this critical question in detail with you.


Software as a medical device:

  • Decision support for the question: Is your app a medical device?
  • Decision support for the classification of your medical app in the respective risk class.
  • Medical App Validation
  • Consulting on the Unique Device Identification (UDI) system (since April 2017 also mandatory for medical apps)
  • Compliance Awareness Workshops
  • Assessment of your existing quality management system or creation of a new one
  • Update from ICH9001 to ISO 14971
  • Preparation and review of the Standard Operating Procedures (SOP)


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