Software in Medical Devices, by MD101 Consulting

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Friday, 26 July 2024

Once again MDR and rule 11 are proven to be wrong

And this is the Australian TGA who demonstrates that.

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Friday, 29 March 2024

New IMDRF document on Medical Device Software

The IMDFR organization published in January 2024 a new document on Medical Device Software: Considerations for Device and Risk Characterization
Say briefly, this document is a gem!

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Friday, 22 April 2022

New SaMD Classification scheme

A new unofficial SaMD classification scheme. Will it be adopted with the postponement of the MDR?

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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FDA Draft Guidance on Content of Premarket Submissions for Device Software Functions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 The draft guidance Content of Premarket Submissions for Device Software Functions opens the ball in 2021. This draft guidance will supersede the guidance titled Content of Premarket Submissions for Software Contained in Medical Device, when it is published in its final version.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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Friday, 26 March 2021

When Web meets SOUP

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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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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Wednesday, 9 October 2019

What happened to my Drug Prescription Assistance Software?

We know that Drug Prescription Assistance Software are software as a medical device, thanks to the European Court of Justice. But how to CE mark that kind of software?

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Sunday, 26 May 2019

MDR: one year left and too late for class I software

Today is the 26th of May 2019. Rings a bell? In one year exactly, your class I MD software will be living in borrowed time on the EU market.
Why?
Because of rule 11 of 2017/745/UE Medical Device Regulation (MDR).

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Friday, 19 January 2018

FDA Guidance on Medical Device Accessories updated

Here is a quick follow-up of the new version of the FDA Guidance titled Medical Device Accessories – Describing Accessories and Classification Pathways, published in December 2017. This comes a bit in parallel to the Section 3060 guidance described in the previous post on the 21st Century Cures Act.

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