Software in Medical Devices, by MD101 Consulting

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.

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.

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.

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.

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.

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 The draft guidance Content of Premarket Submissions for Device Software Functions opens the ball in 2021. This draft guidance will supersede the guidance titled Content of Premarket Submissions for Software Contained in Medical Device, when it is published in its final version.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.

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

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.

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.

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.