Software in Medical Devices, by MD101 Consulting

To content | To menu | To search

Regulations

Entries feed - Comments feed

Friday, 20 October 2023

New version of the FDA guidance on off-the-shelf software use in medical devices

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.

Continue reading...

Friday, 6 October 2023

Final 2023 FDA Premarket Cybersecurity guidance released

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.

Continue reading...

Friday, 16 June 2023

Final FDA guidance on Content of Premarket Submissions for Device Software Functions

The final version of the FDA guidance on Content of Premarket Submissions for Device Software Functions has been published.

Continue reading...

Monday, 9 January 2023

IEC 81001-5-1 was added to the list of recognized consensus standards

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

FDA Guidance on Clinical Decision Support Software

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.

Continue reading...

Friday, 16 December 2022

Manual on Borderline Classification Version 2 - December 2022

The Manual on borderline and classification under Regulations (EU) 2017/745 and 2017/746 - Version2 - December 2022 has been published yesterday.

Continue reading...

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.

Continue reading...

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.

Continue reading...

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.

Continue reading...

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.

Continue reading...

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.

Continue reading...

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.

Continue reading...

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.

Continue reading...

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.

Continue reading...

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.

Continue reading...

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.

Continue reading...

Wednesday, 26 May 2021

Rest in peace class I SaMD

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

Continue reading...

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.

Continue reading...

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.

Continue reading...

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.

Continue reading...

- page 1 of 5