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Wednesday, 18 January 2012
By Mitch on Wednesday, 18 January 2012, 10:33
Breast implants are technically far from software and one may say they don’t have anything in common. Yes, they do, when software is part of a medical device, they are both subject to the regulation of the 93/42 CE directive.
Is it possible to have a massive injury of people with software, like the one we discovered with the breast implants scandal?
To understand how this happened, let us begin with a brief history of the CE mark.
Monday, 28 November 2011
By Mitch on Monday, 28 November 2011, 17:19
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.
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.
Friday, 25 November 2011
By Mitch on Friday, 25 November 2011, 15:51
In How to classify and CE mark software, I tried to make a thorough explanation about how to obtain CE mark for software medical devices. Here is a short explanation about Canadian rules.
Monday, 14 November 2011
By Mitch on Monday, 14 November 2011, 10:32
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 The FDA is clear about these "mobile medical apps" in a draft guidance published in july 2011: "For the subset of mobile medical apps that are subject to regulatory oversight, manufacturers must meet the requirements associated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 see the Draft Guidance.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!
Friday, 4 November 2011
By Mitch on Friday, 4 November 2011, 14:20
Medical devices shall have CE mark before being sold in the EU. The process to have CE mark can be summarized this way:
Software follows exactly the same process as other devices. Here are the steps to follow to CE mark software.
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