CE marking of apps: It Can Be Done and Here Is How
If there is one thing that I have learnt by now working with medical apps and medical device law is that physicians have little idea about rules for apps with medical functionality, companies are in the dark about how to CE mark their apps and EU regulators start to slowly devote some attention to this phenomenon, while the FDA is trying to keep the pace of developments. Regulatory compliance is a starting to take serious proportions in the field of medical apps and when physicians are using them more and more, it is just a matter of time before the scandals start popping up and patients suffer the consequences. Better be compliant from the start, that’s a good business model if you ever want to sell your company for a good price or avoid product liability lawsuits.
For those reasons it is very nice to come across an initiative that shows that It Can Be Done and Here Is How by the UK charity d4. d4 mission is to draw attention to the regulation of health apps and publishes guidance document to help health professionals, organisations, patients and industry.
It Can Be Done
With respect to the It Can Be Done I would like to draw your attention to a new app, Mersey Burns ( a clinical tool for estimating burn area percentages, prescribing fluids using Parkland, background fluids and recording patients’ details) that was the first app to be officially registered at the UK MHRA as per the local implementation of the Medical Devices Directive. I am celebrating this event because I have no idea if apps have already been registered as class I devices in the Netherlands, for example. I also don’t know which app was the first to ever complete all regulatory requirements for the EU and I know there are some on the market already. However, this is a great example of development and deployment of compliant apps in the scope of the EU medical devices directives, which makes it newsworthy.
Here Is How
Regarding the ‘Here Is How’ d4 published a new guidance document to help draw further attention to the issue of health app regulation and provide practical guidance to both users and manufacturers of apps for the healthcare market. The primary purpose of this guide is to highlight the challenges that surround the provision and use of health apps from a regulatory standpoint, whether as a patient, health care professional, application developer, healthcare organisation, pharmaceutical or medical devices company. That’s right, this document is interesting for all parties concerned with the development, use and implementation of the app.
Although the guidance document has been developed primarily for the UK market, it is a very good guide for other EU member states too, as the system for regulation of medical apps will be similar if not identical because of the harmonization by the EU Medical Devices Directive. I can testify to that as I was involved in some last minute minor edits to the guide.
You can download the guide for free on the website of d4. It’s good reading if you are a hospital starting to work with apps, a developer starting to develop apps or a device manufacturer that wants to develop and deploy your first app. If you can read Dutch, here is a presentation that I did recently together with a French/Dutch company that has an telemedicine product on the Dutch and French markets about how to do compose a technical file and set up a quality system for software as a medical device.