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Friday, 23 November 2012
By Mitch on Friday, 23 November 2012, 13:06
The Global Harmonization Task Force released an update of their guidance on Essential Principles of Safety and Performance of Medical Devices. It supersedes the last version released in 2005.
Friday, 12 October 2012
By Mitch on Friday, 12 October 2012, 06:42
Here is the second part of my last article about EU Proposal of new regulation.
Monday, 8 October 2012
By Mitch on Monday, 8 October 2012, 11:13
The proposal of new regulation for CE Mark of medical devices was unveiled last week. If you've not heard about it, you were in the desert without access to the internet.
I won't argue on the length of the document or the consequences of this possible new regulation on the early release of technologic improvements in the european market. I invite you to have a look at Mat's article.
Let's see what's new for software in this proposal. To do so, I took my best PDF viewer and searched for "software" in the actual directive and in the new proposal.
Friday, 30 March 2012
By Mitch on Friday, 30 March 2012, 10:51
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.
Wednesday, 22 February 2012
By Mitch on Wednesday, 22 February 2012, 09:21
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.
Hope you enjoy it :-)
Monday, 6 February 2012
By Mitch on Monday, 6 February 2012, 18:14
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After the draft guidance of the FDA about mobile apps, after the guide on regulation of health apps by a UK medical charity, this MEDEV is the third document released in a few months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.
Saturday, 28 January 2012
By Mitch on Saturday, 28 January 2012, 11:40
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.
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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