Software in Medical Devices, by MD101 Consulting

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Friday 30 September 2022

NIS2 Directive: are you involved or concerned?

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.

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Friday 2 September 2022

MDCG 2022-14: Red Queen Effect

The MDCG published in August 2022 the MDCG 2022-14 position paper on Notified body capacity and availability of medical devices and IVDs.

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Monday 27 June 2022

MDR: Les Shadoks and MHRA: The Gibis

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.

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Friday 10 June 2022

Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submission

The FDA issued in April a new draft guidance on Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions.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 There’s no word about the draft guidance of 2018. We can suppose that one is obsolete.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

The MDR is born bad

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

Software as a Medical Device Post-Market Surveillance

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 15 April 2022

SaMD decommissioning, recall, removal and withdrawal

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

Medical Device lifetime and SaMD

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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Monday 6 December 2021

FDA Draft Guidance on Content of Premarket Submissions for Device Software Functions

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

MDCG 2020-3: Substantial change or not Substantial change?

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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Wednesday 26 May 2021

Rest in peace class I SaMD

This is the end of MDD, and class I SaMD.

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Thursday 4 March 2021

Hey, European Commission, it's time to copy-paste Australian regulation!

The Australian Regulatory changes for software based medical devices took effect from 25th February 2021.

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Friday 5 February 2021

FDA about to exempt fifteen software devices from 510k clearance

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

Is my software in IVDR class A, B, C, or D: A new hope

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

CE marking a new medical device with the MDR or IVDR: will it take one year?

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

Brexit: Regulating medical devices from 1 January 2021 in the UK

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

FDA Guidance on Multiple Function Device Products

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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Sunday 3 May 2020

MDCG 2019-16 Guidance on cybersecurity for medical devices

So we have a new guidance on cybersecurity for medical devices: the MDCG 2019-16. This is not the one we expected so quickly, but we're not going to complain about the existence of this guidance! It was published in December 2019. At last I found time to write a review.
This guidance covers a broad range of topics applicable to all stakeholders in the medical device supply chains, and to end-users. It explains a bit why it is 46 pages long.

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Friday 6 December 2019

Is my software in class I MDD: Stayin' alive

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!

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Thursday 31 October 2019

Is my software in class IIa, IIb, or III, Dark Fate

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.

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