MDR/IVDR Watch / Archive
MIR 7.3.1 manufacturer incident report form: updated XSD/XSL files and changelog (SB 11252)
Deadline 01 May 2026 Published 11 Jun 2026
The new MIR 7.3.1 form is mandatory from 1 May 2026; the page states that all MIR 7.3.1 versions from the December 2025 publication onward are acceptable, and versions published before December 2025 (SB 10781) can no longer be used. New XSD/XSL files and a changelog for SB 11252 are provided for implementation in manufacturers' databases, and the PDF is password-protected for specific authorised uses.
Original title: Update MIR 7.3.1. form – Updated XSD-XSL files for field 4.3.3.d. and Changelog file (SB 11252)
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New MDCG guidance, implementing acts, standards and EUDAMED changes, each explained in two lines: what changed and who must act.
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The Commission announces new measures aimed at making the EU health sector more innovative, competitive and resilient. The headline does not specify whether medical devices or IVDs are directly affected, so the relevance to device manufacturers is unclear from the text provided.
Published 19 Jan 2026
The Commission has published a factsheet on the EU medical device rules, aimed at explaining the benefits of the MDR and IVDR for patients. It is general background material with no new obligations for manufacturers.