risk or benefit?

IT Compliance


The digital transformation now influences virtually every area of our daily lives – and this also includes our health. In this context, mHealth (mobile health) apps now have an important role to play. Based on scientific research, these mHealth apps are applications that are intended to have a positive, long-term influence on our physical, mental and social well-being.

It is estimated that the number of health apps available will soon pass the 400,000 mark. The reasons for this burgeoning trend are not hard to find: almost everyone now owns a smartphone or tablet PC, and mHealth is an area that has the potential to improve the quality and effectiveness of our individual lifestyles, and to revolutionise the field of healthcare. However, many people are unaware that using some of these apps involves substantial risks and dangers – not least because of a lack of quality and validation standards. Apps in this category are known as medical apps. These are applications that are specifically designed to prevent, diagnose and treat illnesses or injuries. They are classified as medical devices and are therefore subject to strict regulatory requirements.

An app is considered to be a medical device if it is covered by the definitions of such devices given in the new European MEDICAL DEVICE REGULATION (MDR) 2017/745 of 5 April 2017. These definitions are typically generic to ensure that they cover many different products.

The decision as to whether an app is a medical device and therefore has certain responsibilities as regards the safety of the software is made by the app developer. This distinction – medical device or not – is specified by the developer in the intended purpose defined for the app. Previously, app developers were able to bypass the strict legal requirements relating to the safety and efficacy of medical devices easily, simply by describing their product as merely a health or fitness app. To close this legal loophole, the FDA published a document (‘Mobile Medical Application – Guidance for Industry and Food and Drug Administration Staff’) in 2013 that explains exactly which apps must now be classified as medical apps.

In Europe, a new Medical Device Regulation (MDR 2017/745) was adopted in April 2017 with the aim of improving public safety and health. Despite all of the above, it is not a trivial matter to determine whether or not an app is actually a medical device. Accordingly, we are happy to draw on our 20 years of experience in regulated environments to help you to resolve issues related to this critical legal requirement.


  • Software as a medical device:
    • Guidance for answering the question: is your app a medical device?
    • Guidance for classifying your medical app in the correct risk class.
  • Medical app validation
  • Advice on Unique Device Identification (UDI) systems (also mandatory for medical apps from April 2017)
  • Compliance awareness workshops
  • Evaluation of your existing Quality Management system or setup of a new QMS
  • Update from ICH 9001 to ISO 14971
  • Preparation and review of standard operating procedures (SOPs)


Make use of our experience and industry expertise as medical app compliance specialists!

  • 20 years of expertise in GxP compliance
  • A wealth of expertise in regulatory requirements
  • Broad-based experience with a very wide range of IT systems
  • Integrative approach adopted for existing QM systems
  • High level of knowledge transfer
Matthias Bothe

Managing Director & Industry Unit Manager
Life Sciences, Chemie and Medical Engineering
phone: +49 681 93 666 0

Matthias Bothe, DHC GmbH
Carsten Buri

Director Sales & Marketing
phone: +41 44 500 888 7

Carsten Buri, DHC AG
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