Sunday 3 May 2020
By Mitch on Sunday 3 May 2020, 14:20
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.
Friday 6 December 2019
By Mitch on Friday 6 December 2019, 14:10
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!
Thursday 31 October 2019
By Mitch on Thursday 31 October 2019, 14:03
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.
Wednesday 9 October 2019
By Mitch on Wednesday 9 October 2019, 14:39
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?
Friday 26 July 2019
By Mitch on Friday 26 July 2019, 13:34
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.
Friday 19 July 2019
By Mitch on Friday 19 July 2019, 14:10
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.
Sunday 26 May 2019
By Mitch on Sunday 26 May 2019, 14:00
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.
Because of rule 11 of 2017/745/UE Medical Device Regulation (MDR).
Tuesday 26 March 2019
By Mitch on Tuesday 26 March 2019, 16:21
To be software as a medical device or not to be.
That is the question.
And you rely on Competent Authorities to determine whether software is a medical device or not.
For example, you have some practical examples on the ANSM website (google translate is my Friend): here is the lastest version.
And you wish you had a way to be noticed by the ANSM when the page changes. Hell no, no way.
Especially you wish you had been noticed when the ANSM change their mind on telesurveillance software: here is the previous version on archive.org if you want to compare with the latest.
Before: examples showing that communicating data, like tele follow-up is not a MD, with the invocation of expert function (found in MEDDEV 2.1/6 only for qualification of IVD, not MD) to exclude software without such function.
After: examples showing that tele surveillance is a MD (exit the expert function).
Arrgghh, This isn't Good Regulatory Practice.
Thursday 24 January 2019
By Mitch on Thursday 24 January 2019, 12:50
Friday 19 January 2018
By Mitch on Friday 19 January 2018, 14:15
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.
Friday 12 January 2018
By Mitch on Friday 12 January 2018, 15:00
Since the last blog post on US FDA guidance on software classification, things evolved quickly with the FDA. We know where they want to go with software as medical device, but not exactly how they will implement it.
Let's do a review of what has been done since the publication of the 21st Century Cures Act.
Monday 3 July 2017
By Mitch on Monday 3 July 2017, 14:06
We continue this series of posts on cybersecurity with some comments on impacts of cybersecurity on the software development documentation.
Saturday 6 May 2017
By Mitch on Saturday 6 May 2017, 10:59
The Medical Device Regulation and In-Vitro Device Regulation have been published the 5th May 2017!
See the Official Journal of the EU.
Friday 10 February 2017
By Mitch on Friday 10 February 2017, 14:20
By Mitch on Friday 10 February 2017, 14:19
Monday 24 October 2016
By Mitch on Monday 24 October 2016, 16:50
We begin today a series of posts on cybersecurity in medical devices. Cybersecurity was not a subject before the advent of computerized medical devices. Now that every manufacturer wants its connected medical device, cybersecurity matters!
Let's start with the regulations.
Friday 2 September 2016
By Mitch on Friday 2 September 2016, 13:27
We've seen in the previous article the revolution in the regulatory classification brought by the new rule 10a for standalone software.
Let's see now the other changes. These changes are relevant for all software: standalone, embedded, device or accessory.
They're not as big as the new rule 10a, but they will deserve a significant amount of man-hours and documentation.
Friday 19 August 2016
By Mitch on Friday 19 August 2016, 13:48
The FDA released three new FDA guidances in July 2016:
- Two draft guidances on Deciding When to Submit a 510(k) for a Change to an Existing Device,
- The final guidance on General Wellness: Policy for Low Risk Devices.
Wednesday 10 August 2016
By Mitch on Wednesday 10 August 2016, 10:09
A new version of the MEDDEV 2.1/6 was published in July 2016.
The first version of 2012 was a major breakthrough. The new version won't change you life. Almost nothing new, excepted a few definitions on software, input data, output data, a remarkable reference to IMDRF definitions, and a non-significant update of the first decision tree.
Add to that a few typos, and you have the new version of the MEDDEV:
- "lossless compression" disappeared from the decision tree (was it intentional?) but is still present in the explanations of decision step 3,
- Decision step 7 doesn't have any explanation.
MEDDEV for nothing ♫ and tips for free ♬.
Friday 22 July 2016
By Mitch on Friday 22 July 2016, 13:28
The final version of the negotiated text of the new Medical Device Regulation (MDR) was published by the European Commission in June 2016. It is a big upheaval for all medical device manufacturers. Contrary to what the draft version of September 2015 contained, software is invited to the party.