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Monday 20 February 2023
By Mitch on Monday 20 February 2023, 13:56 - Standards
These three concepts come from IEC 62443 and were adopted in IEC 80001-5-1. SOUP isn't present in IEC 81001-5-1.
What are the differences between SOUP and Maintained software, Supported software, and Required software?
Monday 9 January 2023
By Mitch on Monday 9 January 2023, 15:31 - Regulations
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 good way to make thing (a bit) more simple.
Remark: UL 2900-x can still be applied in the US!
Friday 6 January 2023
By Mitch on Friday 6 January 2023, 13:24 - Regulations
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
By Mitch on Friday 16 December 2022, 13:50 - Regulations
The Manual on borderline and classification under Regulations (EU) 2017/745 and 2017/746 - Version2 - December 2022 has been published yesterday.
Monday 5 December 2022
By Mitch on Monday 5 December 2022, 11:47 - Misc
Hi EPSCO!
I hope you’re doing well!
We’re a bit concerned by your mindset, it looks like you don’t know where you have to go at your meeting of the 9th December.
Please find below some suggestions just for you.
Friday 11 November 2022
By Mitch on Friday 11 November 2022, 13:24 - Processes
That's a bit like a new album of your favorite group. You've been waiting it for years. At last, it's been released! Are you going to be be impressed or disappointed?
The draft FDA guidance on Computer Software Assurance [CSA] for Production and Quality System Software has been published in September 2022. At last!
Friday 30 September 2022
By Mitch on Friday 30 September 2022, 14:01 - Regulations
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
By Mitch on Friday 2 September 2022, 12:47 - Regulations
The MDCG published in August 2022 the MDCG 2022-14 position paper on Notified body capacity and availability of medical devices and IVDs.
Friday 8 July 2022
By Mitch on Friday 8 July 2022, 13:52 - Standards
The 6th June 2022, a draft request has been published to update the list of EU MDR/IVDR harmonized standards. This request brings changes to the list presented in the draft list of April 2021.
Monday 27 June 2022
By Mitch on Monday 27 June 2022, 14:50 - Regulations
The UK Government response to consultation on the future regulation of medical devices in the United Kingdom has been published on Sunday 26th June 2022.
Tuesday 14 June 2022
By Mitch on Tuesday 14 June 2022, 21:41 - Misc
Have you seen the MDCG 2022-11 - MDCG Position Paper: Notice to manufacturers to ensure timely compliance with MDR requirements?
Friday 10 June 2022
By Mitch on Friday 10 June 2022, 13:47 - Regulations
The FDA issued in April a new draft guidance on Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions. This guidance will supersede the guidance on Content of Premarket Submissions for Management of Cybersecurity in Medical Devices of 2014, when it is finalized. There’s no word about the draft guidance of 2018. We can suppose that one is obsolete.
Monday 23 May 2022
By Mitch on Monday 23 May 2022, 13:08 - Regulations
The Medical Device Regulation (MDR) is born bad. The success of a project depends on its timing. It is clear that the MDR has been plagued by a series of setbacks that have hindered its implementation.
Friday 13 May 2022
By Mitch on Friday 13 May 2022, 13:55 - Regulations
Post-Market Surveillance (PMS) is one of the strengthened requirements of the Medical Device Regulation (MDR). Performing an effective PMS can be a time consuming task, shared by several departments of MD manufacturers. This is also true for SaMD.
Friday 22 April 2022
By Mitch on Friday 22 April 2022, 14:20 - Misc
A new unofficial SaMD classification scheme. Will it be adopted with the postponement of the MDR?
Friday 15 April 2022
By Mitch on Friday 15 April 2022, 14:26 - Regulations
We saw in the previous post how the lifetime of a SaMD can be defined. Let's continue with the operations that can affect this lifetime.
Friday 25 February 2022
By Mitch on Friday 25 February 2022, 14:28 - Regulations
Medical device regulations require the manufacturers to define lifetime for their devices. In the case of SaMD, this requirement needs some interpretation.
Thursday 13 January 2022
By Mitch on Thursday 13 January 2022, 13:54 - Standards
IEC 81001-5-1 was published in December 2021. We already talked about the draft version here. Combined with IEC/TR 60601-4-5, published in February 2021, these two standards constitute the state of the art in cybersecurity of medical devices in Europe.
The final version is very close to the draft version, apart from a few changes to the organizational requirements; formerly clause 10 present in the draft, but removed and copied to clause 4 in the final version.
Be prepared to apply these two standards for your MDR CE Mark submissions, when they are harmonized. Most probably by 2024.
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.
Monday 8 November 2021
By Mitch on Monday 8 November 2021, 13:56 - Regulations
That is the question.
MD manufacturers are pressed by end-users to implement changes. Especially SaMD, where the users are used to receiving new versions weekly or monthly. Thus, Class I MDD SaMD manufacturers are pressed to find a way to qualify their software changes as non-substantial according to the MDCG 2020-3. Otherwise, they can't deliver new versions to their end-users, blocked by the deadly MDR rule 11 and its class IIa trap.
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