Friday, 6 April 2012
By Mitch on Friday, 6 April 2012, 11:08 - Misc
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.
Continue reading...
Friday, 30 March 2012
By Mitch on Friday, 30 March 2012, 10:51 - Regulations
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.
Continue reading...
Monday, 6 February 2012
By Mitch on Monday, 6 February 2012, 18:14 - Regulations
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After the draft guidance of the FDA about mobile apps, after the guide on regulation of health apps by a UK medical charity, this MEDEV is the third document released in a few months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.
Continue reading...
Monday, 28 November 2011
By Mitch on Monday, 28 November 2011, 17:19 - Regulations
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.
Continue reading...
Friday, 25 November 2011
By Mitch on Friday, 25 November 2011, 15:51 - Regulations
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.
Continue reading...
Friday, 4 November 2011
By Mitch on Friday, 4 November 2011, 14:20 - Regulations
Medical devices shall have CE mark before being sold in the EU. The process to have CE mark can be summarized this way:
- Determining the class of the device,
- Choosing the CE procedure to apply,
- Declaring CE conformity of the device.
Software follows exactly the same process as other devices. Here are the steps to follow to CE mark software.
Continue reading...
