The final version of the FDA guidance on Computer Software Assurance was published in September 2025, three years after its draft version.
Friday, 24 October 2025
Final FDA CSA guidance released
By Mitch on Friday, 24 October 2025, 15:06
Regulations
Thursday, 14 August 2025
TÜV AI.LAB White Papers - whack a mole game
By Mitch on Thursday, 14 August 2025, 13:29
The TÜV AI.Lab published two white papers on the interaction between the AI Act and the MDR:
Better Safe Than Sorry? ISO 13485 and the EU AI Act
and:
AI Act and MDR - A match made in heaven or double the trouble.
Some serious content behind the itching titles.
Friday, 11 July 2025
AIB 2025-1 - MDCG 2025-6 - Welcome to the AI Act, MD manufacturer
By Mitch on Friday, 11 July 2025, 14:09
The Artificial Intelligence Bureau (AIB), in charge of some regulatory aspects of the AI Act, and the MDCG published in June 2025 a common guidance. This guidance is a FAQ, it will be updated when new questions arise.
Friday, 4 July 2025
2025 update of FDA Premarket Cybersecurity guidance
By Mitch on Friday, 4 July 2025, 14:11
A new version of the FDA guidance named Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions was published in June 2025.
The body text had minor updates: clarifications, updated references to standards and guides, editorial corrections. Note that this 2025 guide mentions AAMI SW96, which was not cited in the previous version. This was because SW96 had not yet been published and recognized by the FDA in 2023.
Friday, 27 June 2025
Rogue 11: a MDR story
By Mitch on Friday, 27 June 2025, 13:00
MDCG 2019-11 rev.1 was published in June 2025. Almost 6 years after the first version.
Despite the passage of time, and the advent of modern AI, nothing has really changed. The rigorous approach is more than ever present in this guide.
Friday, 16 May 2025
Team-NB position paper on EU AI Act
By Mitch on Friday, 16 May 2025, 13:53
The Team-NB published the V2 of a position paper on the EU AI Act in April 2025.
It's interesting to see that this paper was published just before the white paper from BSI.
BSI White paper: The EU AI Act meets the MDR
By Mitch on Friday, 16 May 2025, 13:51
BSI Notified Body published in May 2025 a new White Paper on the AI Act and its interactions with MDR / IVDR.
Friday, 11 April 2025
Team-NB questionnaire on artificial intelligence in medical devices
By Mitch on Friday, 11 April 2025, 13:32
The team-NB published a questionnaire on artificial intelligence in medical devices in November 2024. This questionnaire is simply a (very long) list of questions that a Notified Body may take one by one, when they review a technical file of a medical device containing AI.
Friday, 7 February 2025
FDA Guidance on Artificial Intelligence enabled device software functions
By Mitch on Friday, 7 February 2025, 13:53
The FDA published early January 2025, a long-awaited guidance about Artificial Intelligence Enabled device software functions. This guidance contains FDA's recommendations on how to document an AI-enabled device in marketing submissions.
Almost 70 pages long, this guidance is a monster!
Friday, 26 July 2024
Once again MDR and rule 11 are proven to be wrong
By Mitch on Friday, 26 July 2024, 13:12
And this is the Australian TGA who demonstrates that.
Friday, 19 April 2024
Transition or not, your MDD SaMD may die in 2025, not 2028
By Mitch on Friday, 19 April 2024, 13:32
Yes, 2025.
Why? Because Windows 10 end-of-support is the 5th October 2025.
Are there any MDD SaMD running on Windows 11? No, Windows 11 was released the 5th October 2021, just after May 2021.
So, all MDD SaMD are officially running on Windows 10. Till the 5th October 2025.
Thank-you Microsoft, you set a regulatory deadline involuntarily!
Friday, 29 March 2024
New IMDRF document on Medical Device Software
By Mitch on Friday, 29 March 2024, 13:42
The IMDFR organization published in January 2024 a new document on Medical Device Software: Considerations for Device and Risk Characterization
Say briefly, this document is a gem!
Friday, 20 October 2023
New version of the FDA guidance on off-the-shelf software use in medical devices
By Mitch on Friday, 20 October 2023, 14:12
The FDA released in August 2023 a new version of their guidance on off-the-shelf software (OTSS) use in medical devices. It’s worth noting that this guidance didn’t go through a draft version.
Something visible in the content of that guidance.
Friday, 6 October 2023
Final 2023 FDA Premarket Cybersecurity guidance released
By Mitch on Friday, 6 October 2023, 14:09
The final version of the FDA guidance titled "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions was published the 27th September 2023.
Friday, 16 June 2023
Final FDA guidance on Content of Premarket Submissions for Device Software Functions
By Mitch on Friday, 16 June 2023, 13:54
The final version of the FDA guidance on Content of Premarket Submissions for Device Software Functions has been published.
Monday, 9 January 2023
IEC 81001-5-1 was added to the list of recognized consensus standards
By Mitch on Monday, 9 January 2023, 15:31
The FDA added late December 2022 IEC 81001-5-1 to the list of recognized consensus standards.
That's it. After beating around the bush on this blog on whether UL 2900-x or IEC 81001-5-1 would be applicable to 510(k) submissions and other regulatory clearances, we now have the answer.
We can use IEC 81001-5-1 as:
- A Secure Product Development Framework according to the latest draft FDA guidance on cybersecurity,
- A method of answer to GSPR on cybersecurity of EU MDR and IVDR.
A good way to make thing (a bit) more simple.
Remark: UL 2900-x can still be applied in the US!
Friday, 6 January 2023
FDA Guidance on Clinical Decision Support Software
By Mitch on Friday, 6 January 2023, 13:24
The latest version of the FDA Guidance on Clinical Decision Support Software (CDSS) was published in September 2022. Here is a review of the document and a short comparison with the status of CDS with regard to the MDR.
Friday, 16 December 2022
Manual on Borderline Classification Version 2 - December 2022
By Mitch on Friday, 16 December 2022, 13:50
The Manual on borderline and classification under Regulations (EU) 2017/745 and 2017/746 - Version2 - December 2022 has been published yesterday.
Friday, 30 September 2022
NIS2 Directive: are you involved or concerned?
By Mitch on Friday, 30 September 2022, 14:01
That’s the story of the pig and the hen for breakfast: the pig is involved (ham) and the hen is concerned (eggs). With the NIS2 directive in preparation, a medical device manufacturer will be in either situation.
Friday, 2 September 2022
MDCG 2022-14: Red Queen Effect
By Mitch on Friday, 2 September 2022, 12:47
The MDCG published in August 2022 the MDCG 2022-14 position paper on Notified body capacity and availability of medical devices and IVDs.
« previous entries - page 1 of 5
