Software in Medical Devices, by MD101 Consulting - MEDDEV 2.1/6 Guidelines on classification of standalone software released! - 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 820.2024-03-27T15:32:28+01:00Cyrille Michaudurn:md5:9c06172e7cd5ed0f5b192883b657eabbDotclearMEDDEV 2.1/6 Guidelines on classification of standalone software released! - MassimoMurn:md5:de9333c017f3a6963a8a05df2ebc7bc02013-08-06T11:48:59+02:002013-08-06T13:40:49+02:00MassimoM<p>I think it's clear that it's up to the manufacturer to declare a product as a medical device. You can choose not to declare this. But probably no medical operators will use your system, as they must use only CE marked products</p>MEDDEV 2.1/6 Guidelines on classification of standalone software released! - carlaurn:md5:43896c0299264aa19b1201e3c83f25df2013-02-08T14:05:43+01:002013-02-08T14:05:43+01:00carla<p>hi Mitch, so kind of you<br />
i'm reading back all stuff you posted here, very useful indeed!<br />
thanks a lot!</p>MEDDEV 2.1/6 Guidelines on classification of standalone software released! - Mitchurn:md5:756abd1403671010c1186287caf0615c2013-02-08T13:02:29+01:002013-02-08T13:02:29+01:00Mitch<p>Hi Carla,</p>
<p>Complicated, as you say!</p>
<p>"<span style="background-color: rgb(255, 255, 255); color: rgb(51, 51, 51); font-family: Helvetica, Arial, sans-serif; line-height: 18px; ">all i infer that an intended use unambiguously declared by the manufacturer is an unavoidable requirement for a software product to claim it to be a medical device?"</span></p>
<p><span style="background-color: rgb(255, 255, 255); color: rgb(51, 51, 51); font-family: Helvetica, Arial, sans-serif; line-height: 18px; ">Yes, true.</span></p>
<p style="margin: 0 0 1em; color: rgb(51, 51, 51); font-family: Helvetica, Arial, sans-serif; line-height: 18px; background-color: rgb(255, 255, 255); ">And therefore: no unambiguously stated intended used => no medical device => I can go to market safely now with my product as plain software, and in the meantime do all what needs to be done to issue a software medical device later?</p>
<p style="margin: 0 0 1em; color: rgb(51, 51, 51); font-family: Helvetica, Arial, sans-serif; line-height: 18px; background-color: rgb(255, 255, 255); ">Probably yes. I can't say more, unfortunately.</p>MEDDEV 2.1/6 Guidelines on classification of standalone software released! - carlaurn:md5:0f8693eecd6d549231944578b320c8b42013-02-05T20:06:51+01:002013-02-05T20:06:51+01:00carla<p>Hi Mitch,<br />
thank you so much for your kind reply;<br />
I know it's a complicated question<br />
my guess is this: let's say i've got a software that allows collecting, store and communicate patient data: they're medical data, of course.<br />
According to decision step 3 in Meddev 2.1/6 as long as the software performs no actions on data other than those previously listed, the software is not a medical device.<br />
But they're medical data: i collect, store and communicate them in order for someone (a practitioner?) to review them and, maybe, support medical care, or just monitoring health state. However, I do not state an intended use, which doesn't mean someone could use the software as indicated (as well as exploit software for other uses).</p>
<p>And then say I'm not ready to put it on the market as medical device (quality management system is not ready yet even though i'm working to its fine-tuning, no clinical investigations ready yet, and lack of conformity with other requirements for the time being,...)</p>
<p>If i go back to MDD 47/2007, to iso 13485, to iso 14791, to iec 62304, to TR80002-1, i can't say how many references I've found to "manufacturer specified intended use". So, shall i infer that an intended use unambiguously declared by the manufacturer is an unavoidable requirement for a software product to claim it to be a medical device?<br />
And therefore: no unambiguously stated intended used => no medical device => I can go to market safely now with my product as plain software, and in the meantime do all what needs to be done to issue a software medical device later?</p>
<p>I know it's a complicated matter, but though I've read so many things about MDs and related regulations and standards, I can find nowhere someone who's addressed the matter.</p>
<p>Thank you again for reading, have a nice week<br />
Carla</p>MEDDEV 2.1/6 Guidelines on classification of standalone software released! - Mitchurn:md5:db8b7346bd79fe05cc6bebf3c40307402013-02-05T09:33:22+01:002013-02-05T09:33:22+01:00Mitch<p>Hello Carla,</p>
<p>Good question, I don't have the answer. Maybe this is the job of a lawyer to answer that kind of question!</p>
<p>My own opinion is that it's possible to "avoid" claiming an intended use for medical purposes if it's obvious that the device was not specifically designed for medical purposes.</p>MEDDEV 2.1/6 Guidelines on classification of standalone software released! - carlaurn:md5:a1e8679d63dbc416eaf56d9c8873a67e2013-02-02T21:05:25+01:002013-02-02T21:05:25+01:00carla<p>Hi mitch,<br />
i've been reading lot of your stuff, grat job! and thanks for all information you create and share.<br />
i still have a question which i cant' find an ultimate answer to.<br />
Let's say a manufactirer have developed a stand-alone software which handles data in such a way that according to meddev 2.1/6 could be classified as medical device.<br />
Yet the manufacturer hasn't stated that the software is specifically intended for diagnostic and/or therapeutic purposes (see a) decision step 5 in meddev and b) medical device definition in Directive 2007/47/EC).<br />
This being the situation (no intended use stated as diagnosis, prevention, monitoring, treatment) is the software still a medical device? Does the manufacture need CE mark in order to sell the software or can the manufacturer state the software isn't a medical device (say 'cause it doesn't fulfill all the directive requirements) and sell it simply as a software?<br />
Hope my question is clear enough :)<br />
thanks in advance, have a nice sunday<br />
carla (italy)</p>