Monday, 9 January 2023
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 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
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
Friday, 30 September 2022
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
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.
Monday, 27 June 2022
By Mitch on Monday, 27 June 2022, 14:50
Friday, 10 June 2022
By Mitch on Friday, 10 June 2022, 13:47
The FDA issued in April a new draft guidance on Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions.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 There’s no word about the draft guidance of 2018. We can suppose that one is obsolete.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
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
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, 15 April 2022
By Mitch on Friday, 15 April 2022, 14:26
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
Medical device regulations require the manufacturers to define lifetime for their devices. In the case of SaMD, this requirement needs some interpretation.
Monday, 6 December 2021
By Mitch on Monday, 6 December 2021, 13:32
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
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.
Wednesday, 26 May 2021
By Mitch on Wednesday, 26 May 2021, 00:01
This is the end of MDD, and class I SaMD.
Thursday, 4 March 2021
By Mitch on Thursday, 4 March 2021, 17:50
Friday, 5 February 2021
By Mitch on Friday, 5 February 2021, 12:40
A Notice was published in the Federal Register the 15th January 2021, about the exemption of a long list of medical devices from premarket notification. This list, found in table 6 of the Notice, contains 83 class II devices.
Yet, we have to wait for 120 days, to see this Notice published with the list in its final version.
Friday, 25 December 2020
By Mitch on Friday, 25 December 2020, 13:55
After the MDCG guide 2019-11 for the MDR, the MDCG 2020-16 gives the regulatory oversight on In-Vitro Diagnostic medical devices (IVD MD) classification; including software qualified as IVD MD. Let's see the consequences for software.
Friday, 20 November 2020
By Mitch on Friday, 20 November 2020, 14:01
The MDR 2017/745/EU and IVR 2017/746/EU define requirements, present in the Annex VII of both regulations, addressing the conformity assessment process that Notified Bodies shall put in place. It would be an understatement to say that this process will take some time.
Friday, 6 November 2020
By Mitch on Friday, 6 November 2020, 12:23
While the winds of Covid are blowing a bad air on Europe, the UK MHRA published in September 2020 the guidance on regulatory status of medical devices, IVD and AIMD from 1 January 2021.
Friday, 4 September 2020
By Mitch on Friday, 4 September 2020, 14:34
The FDA published in July the final version of the Guidance on Multiple Function Device Products. Despite the absence of the word "software" in the title, it addresses at first software medical devices. It also addresses hardware devices, but we will focus on software in this post.