GxPlex

Subject (as stated): medical devices

7 of 86 tracked instruments.

This is a projection of the tracker, not a separate dataset. Its canonical URL is the tracker.

Status unknown 1 frozen 3 draft 1 in-force 2

Ordered by the lifecycle the values themselves name.

Jurisdiction International 2 EU 2 US 2 Canada 1

Ordered by count, then alphabetically.

Class (as stated) no self-stated class 3 consensus standard 2 legal act 2

The words a document uses about itself. One that uses none is filed under "no self-stated class" — a fact about the reading, not a kind of document.

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Showing 7 of 86 instruments. Clear all filters

Subject (as stated): medical devices — 7 instrument(s) — no change has been detected yet, so rows are alphabetical; they order by change date as soon as one is
Instrument Authority Jurisdiction Status Last verified Last changed Source
EU IVDR European Parliament and Council EU in force verified 2026-07-28 link (opens in new tab) · retrieved
EU MDR European Parliament and Council EU in force verified 2026-07-28 link (opens in new tab) · retrieved
FDA AI device list US Food and Drug Administration US not yet verified frozen register states no status link (opens in new tab)
FDA device cybersecurity US Food and Drug Administration US not yet verified awaiting link (opens in new tab)
Health Canada ML Health Canada Canada draft — under consultation verified 2026-07-28 link (opens in new tab) · retrieved
ISO 13485 ISO/IEC International final tool-read paywalled — progression tracked 2026-07-31 link (opens in new tab) · retrieved
ISO 14971 ISO/IEC International final tool-read paywalled — progression tracked 2026-07-31 link (opens in new tab) · retrieved

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