Software in Medical Devices, by MD101 Consulting

Too many documents in too many places, that’s what I felt the first time I looked for guidances and other similar stuff about software medical devices.
Where do I find relevant documents?
Which one do I begin with?
My answer:
I created a page where I gather my own list of guidances. It’s a selection of guidances and recommendations for CE mark.

Click here to see the list.

Hope you enjoy it :-)

LESSIS, the federation of french editors of medical and social IT systems, proposes the creation of a unique agency to homologate health IT systems. Original article here (in french).

No more than 6 french governmental agencies are in charge of the homologation of health IT systems in France. Following the example of the CE mark, LESSIS proposes to build a common route to certification. Like the Afssaps for medical devices, a unique agency would be in charge of delivering the certificates, auditing the companies and applying sanctions.

The GHTF (Global Harmonization Task Force) issued a draft of a new guidance on medical device classification They recommend to implement four classes for medical devices based on intended use: from class A (lowest risk) to class D (highest risk). And they give a set of rules on how to choose the classification of the devices.

Comparison with regulations

Wait, I've already seen this elsewhere. Classification of devices in Europe (CE mark) and in Canada have systems very similar to what GHTF recommends. This is a good thing to have an ongoing harmonization process. National regulations copy what GHTF recommends and GHTF copies what national regulations require. This is a virtuous circle. Maybe one day the FDA will implement this classification system.

The boom of mobile apps on smart phones clearly impacts the medical devices industry. Doctors are eager to have the last software gadget (the app) on their hardware gadget (the smartphone, the tablet). As a result, many apps on Apple Store and Android Store fall into the scope of medical devices: terminal to remotely display medical images, apps to compute doses of medicines, an so on ... The list is long.

And gess what? These apps shall be certified before being put in the Apple-Android stores. The FDA is clear about these "mobile medical apps" in a draft guidance published in july 2011: "For the subset of mobile medical apps that are subject to regulatory oversight, manufacturers must meet the requirements associated with the applicable device classification." see the Draft Guidance. For the CE mark, the rule is the same, mobile medical apps fall into the category of active medical devices.

The big family of medical devices is getting more and more children. Welcome to the baby smartphone apps!