Sunday 26 May 2019
By Mitch on Sunday 26 May 2019, 14:00 - Regulations
Today is the 26th of May 2019. Rings a bell? In one year exactly, your class I MD software will be living in borrowed time on the EU market.
Because of rule 11 of 2017/745/UE Medical Device Regulation (MDR).
Friday 2 September 2016
By Mitch on Friday 2 September 2016, 13:27 - Regulations
We've seen in the previous article the revolution in the regulatory classification brought by the new rule 10a for standalone software.
Let's see now the other changes. These changes are relevant for all software: standalone, embedded, device or accessory.
They're not as big as the new rule 10a, but they will deserve a significant amount of man-hours and documentation.
Wednesday 10 August 2016
By Mitch on Wednesday 10 August 2016, 10:09 - Regulations
A new version of the MEDDEV 2.1/6 was published in July 2016.
The first version of 2012 was a major breakthrough. The new version won't change you life. Almost nothing new, excepted a few definitions on software, input data, output data, a remarkable reference to IMDRF definitions, and a non-significant update of the first decision tree.
Add to that a few typos, and you have the new version of the MEDDEV:
- "lossless compression" disappeared from the decision tree (was it intentional?) but is still present in the explanations of decision step 3,
- Decision step 7 doesn't have any explanation.
MEDDEV for nothing ♫ and tips for free ♬.
Friday 22 July 2016
By Mitch on Friday 22 July 2016, 13:28 - Regulations
The final version of the negotiated text of the new Medical Device Regulation (MDR) was published by the European Commission in June 2016. It is a big upheaval for all medical device manufacturers. Contrary to what the draft version of September 2015 contained, software is invited to the party.
Wednesday 17 February 2016
By Mitch on Wednesday 17 February 2016, 10:13 - Regulations
Warning: obsolete content. Please read: Is my software in class I, IIa, IIb or III.
Last update on 2016/07/31.
The British Standard Institute published in February 2016 a white paper titled How to prepare for and implement the upcoming MDR – Dos and don’ts. Register on BSI website to download the paper.
This white paper gives top-notch recommendations on the way to compliance with the future EU Medical Device Regulation (MDR), based on the draft version. But their interpretation of MDR classification rules on standalone software are somewhat surprising.
Friday 15 January 2016
By Mitch on Friday 15 January 2016, 14:30 - Standards
IEC 82304-1 Health software -- Part 1: General requirements for product safety standard is still under development. Its status is visible on the page of ISO website, dedicated to IEC 82304-1. There is even a preview of the first three pages of this draft standard.
Wednesday 23 September 2015
By Mitch on Wednesday 23 September 2015, 09:57 - Standards
Long time no see. For those of you guys who have been following this blog for a long time.
Today I have time to write a short article on the new version of IEC 62366 standard: IEC 62366-1:2105 Application of usability engineering to medical devices.
Friday 28 August 2015
By Mitch on Friday 28 August 2015, 12:54 - Regulations
We continue this series on validation of software used in production and QMS with the Validation Protocol and Reports.
Friday 24 July 2015
By Mitch on Friday 24 July 2015, 11:57 - Regulations
We continue this series on validation of software used in production and QMS with the Validation Master Plan (VMP).
Better than endless explanations, I added a Validation Master Plan template to my templates repository page.
Friday 12 December 2014
By Mitch on Friday 12 December 2014, 21:42 - Regulations
When should a manufacturer report devices changes or QMS changes to notified bodies, according to the 93/42/CE directive?
There hasn't been clear criteria, until the Notified Bodies Operating Group (NBOG) published the Best Practice Guide 2014-3 : Guidance for manufacturers and Notified Bodies on reporting of Design Changes and Changes of the Quality System.
Friday 14 February 2014
By Mitch on Friday 14 February 2014, 12:48 - Misc
To conclude this series about clearance of mobile medical apps, here are a few tips to newcomers in the world in medical devices.
Friday 15 November 2013
By Mitch on Friday 15 November 2013, 13:51 - Regulations
Today I begin a new series of articles about developing (or more broadly designing) a smartphone App that is a medical device.
The very first question is:
Is your App a medical device and does it need to be CE Marked or FDA cleared ?
Friday 22 March 2013
By Mitch on Friday 22 March 2013, 11:59 - Regulations
A few words about guidances in Europe. News are rare enough to point them out.
First, the guidance on electronic labelling came into force on 1st march 2013, see the MHRA website for some explanations and the original decision on the EU website.
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
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
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.
Friday 9 March 2012
By Mitch on Friday 9 March 2012, 13:45 - Standards
Don't worry, I'm not going to talk about money and quantitative easing! I let people with better knowledge in economics (that makes a lot of people!) do that.
When I talk about inflation, I mean the inflation of software medical devices in their number and variety, which creates a collateral inflation in the number of regulations, guidances, standards, and the like.
This post is the first of a series of three. In this first post, I focus on the inflation of standards. The next one will be on the inflation of regulations and the last one on the inflation of medical devices.
Wednesday 22 February 2012
By Mitch on Wednesday 22 February 2012, 09:21 - Regulations
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
Where do I find relevant documents?
Which one do I begin with?
I created a page where I gather my own list of guidances. It’s a selection of
guidances and recommendations for CE mark.
here to see the list.
Hope you enjoy it :-)
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.
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.
Wednesday 18 January 2012
By Mitch on Wednesday 18 January 2012, 10:33 - Regulations
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.
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.