Software in Medical Devices, by MD101 Consulting

To content | To menu | To search

Regulations

Entries feed - Comments feed

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...

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FDA Draft Guidance on Content of Premarket Submissions for Device Software Functions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 The draft guidance Content of Premarket Submissions for Device Software Functions opens the ball in 2021. This draft guidance will supersede the guidance titled Content of Premarket Submissions for Software Contained in Medical Device, when it is published in its final version.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

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.

Continue reading...

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.

Continue reading...

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.

Continue reading...

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.

Continue reading...

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!

Continue reading...

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.

Continue reading...

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?

Continue reading...

Friday 26 July 2019

Guideline on Cybersecurity from ANSM French Competent Authority

The ANSM French Competent Authority published in July 2019 a draft guideline on cybersecurity for medical devices. The European medical device sector should greatly applaud this initiative. This is the first and only guideline on cybersecurity with regard to the European medical device regulations.

Continue reading...

Friday 19 July 2019

Guidance from GMED Notified Body on significant changes in the framework of article 120 of MDR

The GMED notified body has published a guide on substantial changes: named Guidance document for the interpretation of significant changes in the framework of article 120: “Transitional provisions” of Regulation (EU) 2017/745. This guide addresses changes according to the article 120 of the MDR. It's a decision tree in the same vein as FDA guidances on deciding when to submit a new 510k.

As a manufacturer, your mission, if you accept it, is to answer "No" for all your products CE marked with the MDD.
For hardware, be prepared to place your design in the freezer.
For software, be prepared to place your design in liquid nitrogen.

The guidance is on the page on white papers of GMED website.

- page 1 of 4