And this is the Australian TGA who demonstrates that.
Friday, 26 July 2024
Once again MDR and rule 11 are proven to be wrong
By Mitch on Friday, 26 July 2024, 13:12 - Regulations
Tag - CE Mark
Friday, 30 September 2022
NIS2 Directive: are you involved or concerned?
By Mitch on Friday, 30 September 2022, 14:01 - Regulations
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.
Friday, 13 May 2022
Software as a Medical Device Post-Market Surveillance
By Mitch on Friday, 13 May 2022, 13:55 - Regulations
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.
Friday, 15 April 2022
SaMD decommissioning, recall, removal and withdrawal
By Mitch on Friday, 15 April 2022, 14:26 - Regulations
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.
Friday, 25 February 2022
Medical Device lifetime and SaMD
By Mitch on Friday, 25 February 2022, 14:28 - Regulations
Medical device regulations require the manufacturers to define lifetime for their devices. In the case of SaMD, this requirement needs some interpretation.
Friday, 6 December 2019
Is my software in class I MDD: Stayin' alive
By Mitch on Friday, 6 December 2019, 14:10 - Regulations
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
Is my software in class IIa, IIb, or III, Dark Fate
By Mitch on Thursday, 31 October 2019, 14:03 - Regulations
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
What happened to my Drug Prescription Assistance Software?
By Mitch on Wednesday, 9 October 2019, 14:39 - Regulations
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?
Sunday, 26 May 2019
MDR: one year left and too late for class I software
By Mitch on Sunday, 26 May 2019, 14:00 - Regulations
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).
Friday, 2 September 2016
EU Medical Device Regulation - Changes for software
By Mitch on Friday, 2 September 2016, 13:27 - Regulations
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.
Wednesday, 10 August 2016
MEDDEV 2.1/6 2016
By Mitch on Wednesday, 10 August 2016, 10:09 - Regulations
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
Is my software in class I, IIa, IIb or III - 2016 Revolution
By Mitch on Friday, 22 July 2016, 13:28 - Regulations
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.
Wednesday, 17 February 2016
Breaking news: standalone software is not an active medical device!
By Mitch on Wednesday, 17 February 2016, 10:13 - Regulations
Warning: obsolete content. Please read: Is my software in class I, IIa, IIb or III.
Last update on 2016/07/31.
The British Standard Institute published in February 2016 a white paper titled How to prepare for and implement the upcoming MDR – Dos and don’ts. Register on BSI website to download the paper.
This white paper gives top-notch recommendations on the way to compliance with the future EU Medical Device Regulation (MDR), based on the draft version. But their interpretation of MDR classification rules on standalone software are somewhat surprising.
Friday, 15 January 2016
IEC 82304-1 - latest news about the standard on Health Software
By Mitch on Friday, 15 January 2016, 14:30 - Standards
IEC 82304-1 Health software -- Part 1: General requirements for product safety standard is still under development. Its status is visible on the page of ISO website, dedicated to IEC 82304-1. There is even a preview of the first three pages of this draft standard.
Wednesday, 23 September 2015
IEC 62366-1 becomes recognized by the FDA
By Mitch on Wednesday, 23 September 2015, 09:57 - Standards
Long time no see. For those of you guys who have been following this blog for a long time.
Today I have time to write a short article on the new version of IEC 62366 standard: IEC 62366-1:2105 Application of usability engineering to medical devices.
Friday, 28 August 2015
Validation of software used in production and QMS - Part 3 Validation Protocol and Reports
By Mitch on Friday, 28 August 2015, 12:54 - Regulations
We continue this series on validation of software used in production and QMS with the Validation Protocol and Reports.
Friday, 24 July 2015
Validation of software used in production and QMS - Part 2 Validation Master Plan
By Mitch on Friday, 24 July 2015, 11:57 - Regulations
We continue this series on validation of software used in production and QMS with the Validation Master Plan (VMP).
Better than endless explanations, I added a Validation Master Plan template to my templates repository page.
Friday, 12 December 2014
NBOG’s Best Practice Guide 2014-3: all you wanted to know about reporting software design changes
By Mitch on Friday, 12 December 2014, 21:42 - Regulations
When should a manufacturer report devices changes or QMS changes to notified bodies, according to the 93/42/CE directive?
There hasn't been clear criteria, until the Notified Bodies Operating Group (NBOG) published the Best Practice Guide 2014-3 : Guidance for manufacturers and Notified Bodies on reporting of Design Changes and Changes of the Quality System.
Friday, 14 February 2014
How to develop a smartphone App to be FDA-cleared or CE Marked? - part 6 Conclusion
By Mitch on Friday, 14 February 2014, 12:48 - Misc
To conclude this series about clearance of mobile medical apps, here are a few tips to newcomers in the world in medical devices.
Friday, 15 November 2013
How to develop a smartphone App to be FDA-cleared or CE Marked? - part 1 regulations
By Mitch on Friday, 15 November 2013, 13:51 - Regulations
Today I begin a new series of articles about developing (or more broadly designing) a smartphone App that is a medical device.
The very first question is:
Is your App a medical device and does it need to be CE Marked or FDA cleared ?
« previous entries - page 1 of 2
