Software in Medical Devices, by MD101 Consulting - MDR: one year left and too late for class I software - 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:md5:9c06172e7cd5ed0f5b192883b657eabbDotclearMDR: 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>