Software in Medical Devices, by MD101 Consulting

Today I begin a new series of articles about developing (or more broadly designing) a smartphone App that is a medical device.

The very first question is:

Is your App a medical device and does it need to be CE Marked or FDA cleared ?

This article is the last of three articles which deal with the concept of "inflation" of medical devices. The first one was on inflation of standards, the second about inflation of regulations. This one, the most interesting to my eyes, is about multiplication of apps on mobile devices, especially smartphones and tablets.
More that 6000 apps are classified in the "heath", "heathcare" or "medical" categories of the Apple or Android appstores. Many of these apps are classified as medical devices and are in the scope of regulations like FDA and CE Mark. Note that some apps may be regulated the FDA but not the CE Mark or vice-versa.

Don't worry, I'm not going to talk about money and quantitative easing! I let people with better knowledge in economics (that makes a lot of people!) do that.
When I talk about inflation, I mean the inflation of software medical devices in their number and variety, which creates a collateral inflation in the number of regulations, guidances, standards, and the like.
This post is the first of a series of three. In this first post, I focus on the inflation of standards. The next one will be on the inflation of regulations and the last one on the inflation of medical devices.

New! MEDDEV 2.1/6 Guidelines on classification of standalone software released!
HIS, CIS, PDMS, RIS, PACS, LIMS … Which ones are medical devices, which ones are not?
To answer this question, the European Commission issued a new Guidelines document: MEDDEV 2.1/6, about the qualification and classification of standalone software as Medical Devices or In Vitro Diagnosis Devices.
Download here
After the draft guidance of the FDA about mobile apps, after the guide on regulation of health apps by a UK medical charity, this MEDEV is the third document released in a few months about standalone software.

Medical devices shall have CE mark before being sold in the EU. The process to have CE mark can be summarized this way:

1. Determining the class of the device,
2. Choosing the CE procedure to apply,
3. Declaring CE conformity of the device.

Software follows exactly the same process as other devices. Here are the steps to follow to CE mark software.