Software in Medical Devices, by MD101 Consulting

We saw in the previous post how the lifetime of a SaMD can be defined. Let's continue with the operations that can affect this lifetime.

So we have a corrigendum (almost 100% sure. A vote by the EU Parliament is still in the pipe December the 16th, though). To corrigendumize: that's a neologism I propose to name bug fixing activities in legal matters. I corrigendumize, you corrigendumize, they corrigendumize! Any resemblance to "randomize" is purely coincidental!

We know that Drug Prescription Assistance Software are software as a medical device, thanks to the European Court of Justice. But how to CE mark that kind of software?

We've seen in the previous article the revolution in the regulatory classification brought by the new rule 10a for standalone software.
Let's see now the other changes. These changes are relevant for all software: standalone, embedded, device or accessory.
They're not as big as the new rule 10a, but they will deserve a significant amount of man-hours and documentation.

The final version of the negotiated text of the new Medical Device Regulation (MDR) was published by the European Commission in June 2016. It is a big upheaval for all medical device manufacturers. Contrary to what the draft version of September 2015 contained, software is invited to the party.

IEC 82304-1 Health software -- Part 1: General requirements for product safety standard is still under development. Its status is visible on the page of ISO website, dedicated to IEC 82304-1. There is even a preview of the first three pages of this draft standard.

We continue this series on validation of software used in production and QMS with the Validation Protocol and Reports.

When should a manufacturer report devices changes or QMS changes to notified bodies, according to the 93/42/CE directive?
There hasn't been clear criteria, until the Notified Bodies Operating Group (NBOG) published the Best Practice Guide 2014-3 : Guidance for manufacturers and Notified Bodies on reporting of Design Changes and Changes of the Quality System.

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.