IEC 62304 was first published in 2006. Amendment 1 followed in 2015, and the current consolidated version, IEC 62304:2006+AMD1:2015 (edition
IEC 81001-5-1:2021, edition 1.0, was published on 16 December 2021. In December 2025, IEC issued Interpretation Sheet 1 and a
On 18 December 2025, MDSAP documents moved to a new website, mdsap.global, managed by Australia's TGA (FDA). Since 2 February
In May 2026, FDA finalised "Content of Human Factors Information in Medical Device Marketing Submissions", replacing the December 2022 draft
ISO 13485:2016 was last reviewed and confirmed by ISO in 2025, so the 2016 edition remains current. In the EU,
Article 51 of the MDR, Regulation (EU) 2017/745, divides devices into classes I, IIa, IIb and III, using the 22
ISO/IEC 27001:2022, the third edition, was published in October 2022. Amendment 1, on climate action changes, followed in February 2024
The MDR (Regulation (EU) 2017/745 of 5 April 2017) requires risks to be acceptable "taking into account the generally acknowledged
Regulation (EU) 2017/745 of 5 April 2017, the MDR, introduced the summary of safety and clinical performance (SSCP) in Article
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