Software in Medical Devices, by MD101 Consulting - Tag - Classification - CommentsBlog about software medical devices and their regulatory compliance. Main subjects are software validation, IEC 62304, ISO 13485, ISO 14971, CE mark 93/42 directive and 21 CFR part 820.2024-03-18T07:25:39+01:00Cyrille Michaudurn:md5:9c06172e7cd5ed0f5b192883b657eabbDotclearIs my software in class A, B or C? - Mitchurn:md5:8f49068be58b8057c2e9e4ffc707b0ae2022-09-21T18:34:50+02:002022-09-21T17:34:50+02:00MitchHi, the medical image database only for storage is not regulated as medical device. Regards.Is my software in class A, B or C? - Shubhangi Chouhanurn:md5:53e3ba58e251a621563da3e7ae04edea2022-09-19T15:24:37+02:002022-09-19T14:24:37+02:00Shubhangi Chouhan<p>My SW system has three items:</p>
<p>1) User Interface: used for user login, (Non medical)<br />
2) Data Storage: used for secure storage and retrieval of patients wound image Class ??<br />
3) Image analyzer: used to sizing and segmentation of wound to suggest treatment to nurse (classIIa)</p>
<p>My question is about the data storage platform Item, is that consider as MD, if this only for storage purpose?</p>
<p>Thank you</p>Is my software in class I MDD: Stayin' alive - Mitchurn:md5:4ed2d8df45850de549b9d9de9eb1ce652020-12-04T11:40:18+01:002020-12-04T11:40:18+01:00MitchHi Kahina,
A MDD class I software can be placed on the market until May 2024. Thus, the deadline to implement a QMS is May 2024 and CE mark your software in class IIa. It means that you've initiated this work 24 months before!Is my software in class I MDD: Stayin' alive - Kahinaurn:md5:385e9b6401d3c87aafa5d26be5ce50012020-12-01T17:01:37+01:002020-12-01T17:01:37+01:00Kahina<p>Hey Mitch,<br />
Merci pour ce superbe travail!<br />
Un logiciel de classe I selon MDD passera en IIa selon MDR, quelle serait la date butoir pour mettre en place un SMQ ?<br />
Merci d'avance</p>Is my software in class I MDD: Stayin' alive - Mitchurn:md5:5c20c39a2c1a0bd90321237a964b7cdd2020-11-13T17:43:51+01:002020-11-13T17:47:25+01:00MitchIt's not a matter of class I. Regulatory requirements on risk management are exactly the same for every class.
ISO 14971:2019 isn't harmonized, this is why I didn't mention it in this article. There are lots of comments about ISO 14971:2019 not being harmonized on the web!
Just take it like this:
-ISO 14971:2012 is enough for the MDD/IVDD/AIMDD, with annexes ZA, ZB, ZC giving the deviations between the standard and the regulations.
-ISO 14971:2019 is for the MDR/IVDR, but is not enough. You also have to make your own assessment of deviations between the annex I of the MDR, which defines requirements on risk management, and ISO 14971:2019.
As soon as we have the annexes ZD, and ZE for the MDR and IVDR in EN ISO 14971:2019, this standard will be enough for the MDR/IVDR.Is my software in class I MDD: Stayin' alive - Oliverurn:md5:eaf6d6f5c90d8865f37d5068ae12b15d2020-11-10T23:01:47+01:002020-11-10T23:01:47+01:00Oliver<p>Hey Mitch, great post as always :)</p>
<p>Quick question: Why the ISO 14971:2012 (emphasis on 2012) for risk management and not the newer version from 2019? Is there anything specific to the old version which makes it more suitable for class I devices?</p>
<p>Thanks! :)</p>
<p>Oliver</p>Is my software in class A, B or C? - Mitchurn:md5:1d2f32d1100d075d2687478bfb8ff9d82020-10-09T19:59:41+02:002020-10-09T18:59:41+02:00Mitch<p>Yes, definitely possible!</p>Is my software in class A, B or C? - Victorurn:md5:a001696df2da92796b265c818fb665e92020-10-08T17:07:26+02:002020-10-08T16:07:26+02:00Victor<p>Is it possible that device has class I but its software has class C? It is out of logic but 62304 does not exclude this case.</p>Is my software in class A, B or C? - Mitchurn:md5:3982c11ed161a27ee6a194877adae5902020-07-24T17:14:38+02:002020-07-24T16:14:38+02:00MitchToss a coin :-)Is my software in class A, B or C? - CAurn:md5:16c78eb1f5dc0e3385d95413509f82a22020-07-20T11:24:26+02:002020-07-20T10:24:26+02:00CA<p>Are baby incubators class B or class c medical devices</p>How to bring legacy software into line with IEC 62304? - part 1 - Mitchurn:md5:29976eed5d4d8f59637854720e3936092020-07-17T16:25:22+02:002020-07-17T15:25:22+02:00MitchHi Mike
I agree with you, the comment you mentioned makes the assumption that the software was legally placed on the market in the first case. If that's no the case, the only solution is reverse-engineering.How to bring legacy software into line with IEC 62304? - part 1 - Mikeurn:md5:c87f44b05a0c594bf3e04ed3c61992fe2020-07-16T19:26:38+02:002020-07-16T18:26:38+02:00Mike<p>Hi Mitch,</p>
<p>In your response of Wednesday 30 August 2017 you stated the possibility of using the Legacy Software requirements of IEC62304 Amd 1 2015 to bring R&D software up to the clinical version. However, how would this be allowed given that the definition of Legacy Software is "medical device software that was legally placed on the market ..."?</p>What happened to my Drug Prescription Assistance Software? - Mitchurn:md5:bd7121cef68ca01b9ad87d1fb16bfde72019-10-13T17:26:57+02:002019-10-13T16:26:57+02:00MitchThanks!
I have to review the guidance to assess if my post is still relevant :-)What happened to my Drug Prescription Assistance Software? - David Gurn:md5:09be831810ff66207a277b826a208b9e2019-10-11T23:47:18+02:002019-10-11T22:47:18+02:00David G<p>EU software guidance is now out:<br />
<a href="https://ec.europa.eu/docsroom/documents/37581?locale=en" title="https://ec.europa.eu/docsroom/documents/37581?locale=en" rel="ugc nofollow">https://ec.europa.eu/docsroom/docum...</a></p>MDR: one year left and too late for class I software - Mitchurn:md5:272693b9591b61c717c5cac6f91b6f032019-07-16T09:58:59+02:002019-07-16T08:58:59+02:00Mitch<p>Hi Nicolas,<br />
That's difficult to answer to this question without an analysis of the intended use, device description and indications for use.<br />
But I can try to give an answer: IF your software doesn't provide information used as an aid to diagnosis or therapy, AND your software doesn't monitor physiological processes, THEN your software is in class I.</p>MDR: one year left and too late for class I software - Villeneuveurn:md5:5c76cd5f0db850570d1fc83fd97c127f2019-07-13T16:38:49+02:002019-07-13T15:38:49+02:00Villeneuve<p>Hi,<br />
thanks for this very detail information.</p>
<p>Have you an idea if, as developer of hypnosis session in VR, we are considered in class IIa or class I?<br />
Thanks in advance</p>
<p>Nicolas Villeneuve</p>Is my software in class A, B or C? - Mitchurn:md5:1d245b6b028785978b4134af00e6cb582019-04-22T14:35:20+02:002019-04-22T13:35:20+02:00Mitch<p>Hi Mike,<br />
There's not direct relationship. Regulatory classes and SW safety classes are two different scales coming from two different source.<br />
It's very likely that class I / II / III device contains class A / B / C software. But this is just a rule of thumb.</p>Is my software in class A, B or C? - Mikeurn:md5:d68f7a486c2f9dc4a2b52bdfb73158592019-04-18T18:58:26+02:002019-04-22T13:32:41+02:00Mike<p>How does the software safety class A, B, C relate to the medical devices classification I, II, III ?<br />
Thanks!</p>Is my software in class A, B or C? - Mitchurn:md5:14f865c00bd42756366579b9219a634e2018-08-12T20:40:48+02:002018-08-12T19:41:56+02:00MitchHi Mike,
Yes, this is still a hazard, but with a very high detectability: the device will be put apart if it is inoperable. Thus the hazard has a very low probability. Hazards with very low probability are usually acceptable. Do the math with your risk assessment criteria to verify whether it is acceptable or not. Then apply the diagram of section 4.3 of IEC 62304 + Amd1 2015 to see if your device is in class A.
Regards.Is my software in class A, B or C? - Mikeurn:md5:197f836a35a09277ad7f26532bf436f02018-08-09T18:40:47+02:002018-08-12T19:34:09+02:00Mike<p>Hi Mitch, I understand if a compromised Firmware update is installed on a diagnostic instrument it can be a hazard when the instrument produces an incorrect result or somehow after beginning a diagnostic test the result is delayed. However, do you know if still considered a hazard if an installed update causes the instrument to be non-operational meaning not able to begin tests in the first place? I can see how an inoperable instrument may cause someone to not be tested (especially if only one on-site) and therefore result in delay of diagnosis and ultimately delay in treatment. I am just not sure if that is how it is viewed by governing bodies or where the line is drawn. Thanks!</p>