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EU MDR postponed to May 2021

Medical Device Regulation (MDR) is postponed until 2021

The new European Union regulations for medical devices will now come into full force on May 26th 2021. Transitioning from the Medical Device Directive (MDD) to the Medical Device Regulation (MDR) has kept the med tech and pharma sectors extremely busy over the last couple of years. The MDR introduces some significant changes to the way in which medical device software and apps can be legally marketed within Europe and this has created some considerable challenges for some of the smaller eHealth start-ups. So why the delay?

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Featured Resources

Guide to regulation of medical appsMedical App Regulation

Read our Quick Guide to Medical App Regulation to see if your app meets the definition of a medical device and requires CE Marking. If you’re involved in developing a medical app then you should be considering the regulatory aspects before you start your project. If your app is classed as medical device software (MDSW) then it will need to go through CE Marking. To help you get started we’ve created this simple guide about medical app regulation.

How mHealth Is Improving HealthcaremHealth White Paper

Read our How mHealth is improving health and social care white paper. With approximately five billion smartphone users worldwide, there are huge opportunities for mobile health (mHealth) apps and other technology to revolutionise healthcare and patient outcomes and experience. This is reflected in economic forecasts and a report by  Mordor Intelligence suggests that the global mHealth market will reach $62.84 billion by 2021.

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Check out our useful tools and informative documents designed to help you with your health and medical app development projects.

Resources for app developers & e-Health entrepreneurs

Directory, articles & news:

Our app developer directory will help you to find an app designer that can work alongside you to map out your mobile health (mHealth) strategy, design & code your app, build a prototype and connect it to a smart medical device, if required.

Our featured articles, news and resources sections will provide you with useful content, eBooks and tools to help get up to speed on the various aspects of developing medical apps and some of the other areas you will need to consider such as medical device compliance and data protection. Furthermore, our site is one of the leading online resources for providing high quality content and advice relating to medical app compliance, CE Marking and developing apps that will be classed as medical device software (MDSW).

We’re always on the look-out for well written articles so if you’d like to use gApps as a platform to share your thought leadership and expertise then learn more about writing for us.

Types of health & medical apps:

  • Health measurement, fitness & wellness – healthcare apps that help patients to better manage medical conditions and lead a healthier lifestyle and apps that helps sports enthusiasts to monitor their activities and performance
  • Clinical interaction – apps that improve communication between HCPs and patients, self-management of medical conditions and medication adherence
  • Hospital administration & patient management – medical apps designed to integrate with admin tools to support patient care & provide access to medical records
  • Medical devices, connectivity & clinical tools– apps that function or connect to medical devices and assist clinicians & pharmacists in performing medical calculations & diagnoses
  • Medical education & clinical trials – apps that operate as resources for medical education, training, clinical pathways, prescribing aids & clinical trials