The harmonised standards under the MDR are listed in Commission Implementing Decision (EU) 2021/1182 and its amendments. The most recent
The IVDR, Regulation (EU) 2017/746, has applied since 26 May 2022. It replaced the list-based approach of Directive 98/79/EC with
For FDA's fiscal year 2027, which started on 1 October 2026, the standard user fee for an original PMA is
In February 2026, FDA issued "Cybersecurity in Medical Devices: Quality Management System Considerations and Content of Premarket Submissions". It supersedes
Article 5(2) of the MDR requires a device to meet the general safety and performance requirements (GSPR) in Annex I
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
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