Software in Medical Devices, by MD101 Consulting - Tag - IEC 81001-5-1 - 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 820.2024-03-29T12:42:03+01:00Cyrille Michaudurn:md5:9c06172e7cd5ed0f5b192883b657eabbDotclearIEC 81001-5-1 Right Here Right Now - Mitchurn:md5:cfd95641de5fc681162e09d6dc86c5872024-02-28T17:30:06+01:002024-02-28T17:30:06+01:00Mitch<p>HI Peter,<br />
Thanks for your feedback.<br />
Yes, it was supposed to be harmonized by May 2024. But the MDCG WG on standards held a meeting the 19 January 2024. This report states that it is being postponed to 2028. There is no official information. But you can find it on lnkn.</p>IEC 81001-5-1 Right Here Right Now - Peter Olssonurn:md5:72d333446a9a6d0339d5ef7a968874b22024-02-26T13:56:48+01:002024-02-26T13:56:48+01:00Peter Olsson<p>Hi,</p>
<p>Interesting article! I have a consideration about the harmonzation of 81001-5-1 during 2028. I thought that 81001-5-1 was supposed to be harminized May 27th this year (2024)?</p>