Software in Medical Devices, a blog by MD101 Consulting

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Inflation of software medical devices - part 2

Today I’m going to talk about the inflation to regulations in the world of software for medical devices. In my previous post, I had a look at the inflation of standards for medical devices. As the medical devices industry is heavily controlled by regulations, they deserve a dedicated post.


The most well-known (or widespread?) regulations are the 21CFR of the USA and the 93/42 directive of the European Union. The FDA has recently increased its number of inspections, mainly in foreigner countries. Even if FDA lacks of agents to do so, the trend is here. And an inspection of the FDA can be compared to being sued. If one day you have one, you’re not going to enjoy it! The regulations themselves don’t change but the FDA will to increase the law enforcement by foreign companies.
On the other side of the Atlantic Ocean, a new directive on medical devices is being drafted by the European commission. The content of this directive is still under construction but some new features are already known. The classification rules will change, for instance products which contain biological substances will be class III. The list of essential requirements will contain new ones, especially about software. This new directive should be released by 2013 or early 2014 and be active a few years later (remember that 2007/47 directive became mandatory in 2010).

What about software?

Focusing on software, we can see the following trend: With the multiplication of standalone software, the FDA and the European Commission felt the urgency to release guidance documents about these kinds of medical devices. The affected types of software are Clinical Decision Support (CDS), like Medical Device Data Systems (MDDS) and mobile Health (mHealth) apps. In general, every kind of software, which belongs to Health IT (HIT) is being watched by regulation agencies.
The excellent article FDA's approach to clinical decision support software depicts the situation with the FDA and the lack of official position about standalone software. FDA decides to regulate almost case by case. However, the FDA issued a draft guidance document about mobile apps. Needless to say that they deserved one, given the maelstrom of new medical apps produced by the emergence of smartphones. The EU hasn’t released an equivalent document to the FDA guidance on mobile apps yet. Its approach is broader, with the MEDDEV 2.1/6 about qualification and classification of standalone software.

An attempt of synthesis

It’s difficult to quickly do a synthesis on trends about software in a short blog article. But the web is a source of precious data. The COCIR (a lobby of European radiological and HIT industry) made a presentation about regulation of medical software, which contains a fair good attempt of synthesis. Read it, it’s very instructive!
The concept of inflation of regulations should not be seen as the multiplication of regulations but more as the mix of three phenomena. National agencies are strengthening the existing regulations. They’re increasing the monitoring and control of manufacturers and distributors. And in the case of software, they’re trying to adapt the regulations to the fast moving world of Health IT.

It's too early to have a worldwide consensus on how to regulate Health IT. Wait and see.

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