Evidence for systems that carry regulated work.
Source-backed reporting and analysis connected to the companies, capabilities, authorities, and operating domains it affects.
Regulation (EU) 2017/746 connects scientific validity, analytical performance, clinical performance, post-market follow-up, and lifecycle updates. One completed study or stored report cannot stand in for that maintained evidence chain.
ISO IDMP defines data structures for identifying and exchanging medicinal-product information. It does not approve a medicine, establish its current authorization status, or show that a dossier or authority submission is complete.
The July package refresh adds forward-compatibility samples and revises regional vocabulary, conformance, and transmission materials for a standard FDA already accepts for new applications.
The June release expands access to structured medicinal-product data while marketing authorisation holders face staged manufacturer and pack-data enrichment deadlines.
The rule now incorporates ISO 13485:2016 by reference and replaces QSIT with a new inspection process, shifting the questions device manufacturers should ask of quality systems and evidence.
Draft revisions to Chapter 4 and Annex 11, plus a proposed Annex 22 for artificial intelligence, signal the direction of travel—but remain consultation drafts rather than operative requirements.
