Monday, 6 December 2021
By Mitch on Monday, 6 December 2021, 13:32 - Regulations
Great news! The FDA announced their list of new or revised guidances for 2022. Software is going to be privileged, with 6 guidances on Clinical Decision Support software, SaMD risk categorization, cybersecurity, QMS SW, and Artificial Intelligence / Machine Learning. The draft guidance Content of Premarket Submissions for Device Software Functions opens the ball in 2021. This draft guidance will supersede the guidance titled Content of Premarket Submissions for Software Contained in Medical Device, when it is published in its final version. This little change in the title is a sign of the times.
Friday, 6 December 2019
By Mitch on Friday, 6 December 2019, 14:10 - Regulations
So we have a corrigendum (almost 100% sure. A vote by the EU Parliament is still in the pipe December the 16th, though). To corrigendumize: that's a neologism I propose to name bug fixing activities in legal matters. I corrigendumize, you corrigendumize, they corrigendumize! Any resemblance to "randomize" is purely coincidental!
Thursday, 31 October 2019
By Mitch on Thursday, 31 October 2019, 14:03 - Regulations
Here we are! White smoke over the European Parliament! The MDCG 2019-11 guidance on qualification and classification of medical device software (MDSW) was published the 11th of October 2019.
Wednesday, 9 October 2019
By Mitch on Wednesday, 9 October 2019, 14:39 - Regulations
We know that Drug Prescription Assistance Software are software as a medical device, thanks to the European Court of Justice. But how to CE mark that kind of software?
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, 19 January 2018
By Mitch on Friday, 19 January 2018, 14:15 - Regulations
Here is a quick follow-up of the new version of the FDA Guidance titled Medical Device Accessories – Describing Accessories and Classification Pathways, published in December 2017. This comes a bit in parallel to the Section 3060 guidance described in the previous post on the 21st Century Cures Act.
Friday, 12 January 2018
By Mitch on Friday, 12 January 2018, 15:00 - Regulations
Since the last blog post on US FDA guidance on software classification, things evolved quickly with the FDA. We know where they want to go with software as medical device, but not exactly how they will implement it.
Let's do a review of what has been done since the publication of the 21st Century Cures Act.
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.
Monday, 26 May 2014
By Mitch on Monday, 26 May 2014, 00:02 - Misc
After MHRA's guidance on standalone software, we continue with another official document published by the International Medical Device Regulators Forum (IMDRF): the consultation on software as a medical device: Possible Framework for Risk Categorization and Corresponding Controls.
Wednesday, 25 September 2013
By Mitch on Wednesday, 25 September 2013, 17:28 - Regulations
After two years of gestation, FDA issues final Guidance on Mobile Medical Apps!
Friday, 1 March 2013
By Mitch on Friday, 1 March 2013, 14:31 - Standards
We've seen in the last post how to manage changes in legacy software. Let's see it from another point of view: the type of legacy software.
Friday, 22 February 2013
By Mitch on Friday, 22 February 2013, 14:09 - Standards
Most of medical devices manufacturers have legacy software that was not designed according to IEC 62304. The devices that embed legacy software were once verified and validated. These devices and their software work well and no major adverse event were raised by software issues.
But one day, the manufacturer decides that it's time to bring that legacy software into line with IEC 62304, to align the technical file of that software (or the contribution of software to technical file content) with up-to-date standard or regulatory requirements.
Monday, 21 January 2013
By Mitch on Monday, 21 January 2013, 15:34 - Standards
In the last two posts, we've seen what a software unit is, and when to do software detailed design, according to IEC 62304 and FDA Guidances.
Saturday, 30 June 2012
By Mitch on Saturday, 30 June 2012, 10:13 - Misc
After a long series of posts about agile methods, let's continue with
something less serious!
If you saw Prometheus, the sci-fi movie about a team of astronauts who search
for human origins, you were probably amazed by the Weyland Corp Medical Pod
720i. Like me.
Monday, 23 April 2012
By Mitch on Monday, 23 April 2012, 05:02 - Misc
I didn't have time to post anything worth it this week.
To give a side view of my last post about software classes, here is a link to DO-178B on wikipedia. It is the reference about software embarked in aircrafts.
If you take time to read this document, you will see that it goes very further than what we have today in IEC 62304. The constraints about design on high classes are very very hard to respect. That's normal, when you think that software is used in flight commands and other stuff in the cockpit.
It has some side effects, mainly to stretch software development projects, and to ban software from some parts of the plane, for cost-driven reasons.
For example, a microcontroler plus software plus electric motors would be perfect to memorize and retreive the position settings of the pilot's seat. But the cost to develop such software is very high, as the pilot's seat is seen as a critical component. Aircraft manufacturers prefer replacing software and microcontroler by good old analogic electronics to do the same task on some models.
In my humble opinion, the constraints of the two highest classes for software in aircrafts would be to high for medical devices. There is always a pratician, or an emergency medical service, able to "catch" the patient if something goes wrong. Whereas there is nobody to "catch" a falling plane if its flight commands fail. The consequences of risks are far higher in aircrafts, with potentially hundreds of victims in an accident.
That is why classes A, B and C, and their design constraints are enough for medical devices.
Next week, I'll talk about exemptions of ISO13485 for standalone software medical devices.
Saturday, 14 April 2012
By Mitch on Saturday, 14 April 2012, 23:35 - Standards
IEC 62304 defines three safety classes for software:
- Class A: No injury or damage to health is possible
- Class B: Non-SERIOUS INJURY is possible
- Class C: Death or SERIOUS INJURY is possible
Here comes the eternal question: Which class my software belongs to?
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.
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.