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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 mHealth 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.

Medical app development guidemHealth App Development Guide

Read our definitive guide to mHealth & medical app development (2020). In this expert-written guide you’ll learn what is medical app development and what you need to consider when developing these types of apps, including medical device compliance. We’ll talk about how medical apps are shaping the future of healthcare and we’ll also provide you with some practical advice about developing medical apps. From developing your mHealth strategy, to choosing the right app developer and medical device compliance.

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mHealth Resources

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

Resources for app developers & e-Health entrepreneurs

Medical App Developer Directory, Articles & News:

If you’re looking for medical app developers for your project then our directory will help you to find an suitable company 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 healthcare 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.