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The FDA issued in April a new draft guidance on Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions.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 There’s no word about the draft guidance of 2018. We can suppose that one is obsolete.
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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.
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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.
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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?
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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.
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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.
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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.
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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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Saturday, 6 November 2021
By Mitch on Saturday, 6 November 2021, 16:18 - Misc
This blog is ten years old!
Thank you to all of you who read, download and share the content of this blog.
Keep goin'
Friday, 9 July 2021
By Mitch on Friday, 9 July 2021, 13:37 - Standards
The draft list of harmonized standards for the MDR regulation was published in May 2021. In this document, we find the references to the following cybersecurity standards:
- IEC 80001-1: Safety, effectiveness and security in the implementation and use of connected medical devices or connected health software - Part 1: Application of risk management,
- IEC 81001-5-1 (not published): Health Software and health IT systems safety, effectiveness and security - Part 5-1: Security - Activities in the product lifecycle,
- IEC/TR 60601-4-5: Medical electrical equipment - Part 4-5: Guidance and interpretation - Safety-related technical security specifications.
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Wednesday, 26 May 2021
By Mitch on Wednesday, 26 May 2021, 00:01 - Regulations
This is the end of MDD, and class I SaMD.
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Friday, 26 March 2021
By Mitch on Friday, 26 March 2021, 13:38 - Misc
The definition of SOUP, and the requirements related to their lifecycle in IEC 62304 processes, are totally independent of any technology. Making no technological assumption, that's the way the standard is thought, so that it can be applied to any health software.
Cloud-based applications and web technologies make an intensive use of SOUPs. Let's see how IEC 62304 requirements can be applied to these technologies.
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Thursday, 4 March 2021
By Mitch on Thursday, 4 March 2021, 17:50 - Regulations
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Friday, 19 February 2021
By Mitch on Friday, 19 February 2021, 13:43 - Standards
That's a déjà-vu. The second version of IEC 62304 is still in draft. It has been in this state for five years, since the publication of the amendment 1. We already had a draft version in 2019. A new draft version is, again, in public review (or has been in public review in your country) under the name IEC CDV 62304:2021. Go to the website of your national standardization organization, to see if you can still download it for free!
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Friday, 5 February 2021
By Mitch on Friday, 5 February 2021, 12:40 - Regulations
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.
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Friday, 25 December 2020
By Mitch on Friday, 25 December 2020, 13:55 - Regulations
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.
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Friday, 20 November 2020
By Mitch on Friday, 20 November 2020, 14:01 - Regulations
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.
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Friday, 6 November 2020
By Mitch on Friday, 6 November 2020, 12:23 - Regulations
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.
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Friday, 4 September 2020
By Mitch on Friday, 4 September 2020, 14:34 - Regulations
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.
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