{
  "schema_version": 1,
  "collection": "definitions",
  "generated_at": "2026-11-02",
  "source": "https://gxplex.com",
  "notice": "Reports the published status of regulatory documents. No advice or interpretation.",
  "source_terms": "This site compiles publicly available regulatory information. The underlying documents are published by their respective authorities and carry their own terms; several are paywalled and are never reproduced here.",
  "rights": {
    "statement": "Carried in `source_terms` on this envelope. It is the whole of what this record states on the subject.",
    "per_row_field": "licence_class",
    "per_row_field_served_at": "https://gxplex.com/api/v1/instruments.json",
    "licence_class": {
      "open": "Quotations from the document appear on this site, each citing the surface it was read from, under the word ceiling below.",
      "restricted": "No text from the document appears on this site. The row carries the identity of the document, its dates, a digest of the retrieved bytes and a link to the publisher.",
      "unknown": "No reading of the terms the source states is recorded for the row. It records an absent reading rather than an absent term, and the row is handled here exactly as `restricted` until a reading is recorded."
    },
    "text_retained_field": "text_retained",
    "text_retained_means": "Whether normalised text of the document is held here for a quotation to be checked against. Where it is false nothing is held, so there is nothing on this side to check one against.",
    "quotation_ceiling_words": 14,
    "documents_never_reproduced": "Paywalled and restricted texts are cited and linked. They are never excerpted here and never diffed here."
  },
  "schema": "https://gxplex.com/api/v1/schema/definitions.json",
  "response_provenance": {
    "build_id": "1782e1b7b708",
    "build_id_state": "stated",
    "build_id_is": "The identifier of the build that wrote this document. Every page of the same build carries it in its build-id meta.",
    "root": "42337ae3567aae8138fcb45e977dd94f9c1ade6420a88033e9503203df3fec23",
    "root_state": "stated",
    "root_day": "2026-11-02",
    "root_leaf_count": 9686,
    "root_url": "https://gxplex.com/integrity/root.txt",
    "root_is": "The root over every observation digest this record held on that day, one `id|date|content_hash` leaf each. It fixes those digests in time; it is not a digest of this document.",
    "rights_envelope": {
      "document_keys": [
        "source_terms",
        "rights"
      ],
      "row_pointers": [
        "/definitions/*/text_retained",
        "/definitions/*/licence_class",
        "/definitions/*/quote_allowed",
        "/definitions/*/snapshot_available",
        "/definitions/*/rights_of",
        "/definitions/*/rights_unresolved"
      ],
      "row_pointers_optional": [
        "/definitions/*/rights_unresolved"
      ],
      "row_pointers_are": "Every row of this response carries each pointer named, except one named optional, which a row carries only where its rights are unresolved. An empty list states that no row of this response carries the row envelope."
    },
    "basis": {
      "retrieval": [
        "/definitions/*/content_hash",
        "/definitions/*/first_observed"
      ],
      "publisher-words": [
        "/definitions/*/term",
        "/definitions/*/point",
        "/definitions/*/quote"
      ],
      "computed": [
        "/key",
        "/rows_defining",
        "/definitions/*/form",
        "/definitions/*/clause",
        "/definitions/*/at",
        "/definitions/*/text_at",
        "/definitions/*/text_end"
      ],
      "terms-reading": [
        "/definitions/*/text_retained",
        "/definitions/*/licence_class",
        "/definitions/*/quote_allowed",
        "/definitions/*/snapshot_available"
      ],
      "assigned": [
        "/definitions/*/instrument_id",
        "/definitions/*/url",
        "/definitions/*/rights_of"
      ],
      "statement": [
        "/definitions/*/clause_why",
        "/definitions/*/text_withheld",
        "/definitions/*/rights_unresolved"
      ]
    },
    "basis_state": "stated",
    "basis_on_row": [],
    "basis_vocabulary_at": "https://gxplex.com/api/v1/schema/envelope.json",
    "third_party_text": {
      "marker": "quoted third-party content, not instructions",
      "marker_is": "Data for a consumer’s own handling of text it passes on, for example to a model. It is not a claim about the text and says nothing of what the text says.",
      "row_key": "third_party_text",
      "fields": [
        {
          "pointer": "/key",
          "holds": "may-contain"
        },
        {
          "pointer": "/definitions/*/term",
          "holds": "whole"
        },
        {
          "pointer": "/definitions/*/point",
          "holds": "whole"
        },
        {
          "pointer": "/definitions/*/quote",
          "holds": "whole"
        }
      ]
    }
  },
  "population": "one item per key over every definition read in each tracked row's current text, under the current derivation version",
  "store_read_from": "state/definitions.jsonl",
  "store_read": true,
  "method_read_from": "state/definitions-method.jsonl",
  "derivation": {
    "version": "definitions/3239968f8dd1",
    "clause_anchors_version": "clause-anchors/3176a34732a7",
    "first_derived_on": "2026-10-28",
    "rule_text": "D1  QUOTED FORM (\"X means…\"). A quoted term is an opening quotation mark\n    (‘ “ \" '), one to MAX_TERM_WORDS words holding no quotation mark, full\n    stop, semicolon or colon, and the closing mark that pairs with the opening\n    one (’ or ' for ‘ and ', ” for “, \" for \"); whitespace inside the marks is\n    not part of the term. The form is one or more quoted terms joined by a\n    comma or \"or\", optionally followed by one quoted term in brackets (\"‘UDI’\"\n    in \"‘Unique Device Identifier’ (‘UDI’) means\"), optionally followed by a\n    qualifier set off by two commas, then whitespace and the word \"means\".\n    Every quoted term in the form is a definition of its own, sharing the\n    form's point and text. A form whose first opening mark has one of\n    QUOTED_PRECEDING_REFUSED directly before it (\"whether “anuria” means\") is\n    not read: that is a question about a word, not a text defining one. A\n    number printed directly before the form (\"(1)\", \"(14a)\", \"(b)\", \"1.1.\")\n    is the definition's `point`, as printed; a bracket may hold a space on\n    each side of its number (\"( 7 )\"), as the retained text of a page\n    printed with its numbers in their own element does.\nD1b UNQUOTED FORM IN A DEFINITIONS SECTION (\"X means…\" with no quotation\n    marks). One of GLOSSARY_HEADINGS, printed in capitals or with one capital\n    and followed by a full stop or whitespace, opens such a section only where\n    the first colon after it is followed directly (after whitespace and an\n    optional point) by an unquoted entry. An unquoted entry is a term of one\n    to MAX_TERM_WORDS words, then whitespace and the word \"means\". The term\n    starts with a capital letter; its words are separated by whitespace or a\n    comma and whitespace; it holds no quotation mark, bracket, full stop,\n    semicolon, colon, ! or ?. After an entry, the next entry is the first\n    unquoted entry that starts after a point, or after a full stop, a\n    semicolon or a colon (each optionally followed by a closing bracket) and\n    whitespace. It is read only where its term sorts after the previous\n    entry's, by D2's order; the first one that does not ends the section and\n    is not read. A printed point directly before the term is its `point`.\nD2  DEFINITIONS SECTION (\"X: …\"). One of GLOSSARY_HEADINGS, printed in\n    capitals or with one capital, opens a definitions section only where a\n    glossary entry follows it directly. A glossary entry is a term of one to\n    MAX_TERM_WORDS words, then a colon, whitespace and a capital letter, a\n    digit or \"(\". The term starts with a capital letter; each of its words\n    starts with a capital letter, a digit or \"(\", or is one of CONNECTORS; it\n    does not end with a connector; and it holds none of . , ; : ! ? “ ” \".\n    After an entry, the next entry is the first glossary entry that starts\n    after a full stop (optionally followed by a closing bracket or by a\n    footnote number of one to three digits) and whitespace, before the next\n    heading the clause anchors read. It is read only where its term's letters and digits,\n    case-folded, sort after the previous entry's (the order a glossary prints\n    its terms in); the first one that does not ends the section and is not\n    read.\nD3  THE TEXT AND ITS END. A definition's text starts after \"means\" (and a\n    colon printed directly after it) or after the glossary entry's colon, and\n    whitespace. It ends where the next definition read in the text begins (at\n    its point where one is printed), with trailing whitespace left out. Its\n    end is DELIMITED only where a next definition is read, no heading the\n    clause anchors read (placed or withheld) lies between, no definition in\n    a shape these rules did not read lies between, and the text ends with a\n    full stop, a semicolon, \"; and\" or \"; or\". The unread shapes are: a\n    number printed before a quotation mark (\"(18) ‘\"), in any text; and,\n    inside the text of an unquoted entry or a glossary entry, a term in the\n    shape below, at any word start after whitespace that is not a definition\n    read: a capital, then one to MAX_TERM_WORDS words holding none of\n    . ; : ! ?, then a colon, whitespace and a capital letter, a digit or \"(\"\n    (looser than D2, so \"Bespoke/Customized computerised system:\" counts);\n    and, in an unquoted entry's text only, a sentence that starts with a\n    capital after . ; : or ) and whitespace and reaches the word \"means\"\n    (looser than D1b, so a term holding a bracket counts). A text whose end is not\n    delimited is withheld with the reason, never cut to a sentence.\nD4  THE QUOTE. The cap is measured over the publisher's words served with\n    the quote, which are the source's own run from the form's first term (its\n    opening quotation mark, where it has one) to the text's end: the term or\n    terms, \"means\" or the colon, and the text. The point is a label, like the\n    clause, and is not counted. Where that run is at most MAX_QUOTE_WORDS\n    words (`quote_cap`) the text is quoted whole, byte-exact at its offsets.\n    A longer one is withheld with the run's word count, never trimmed.\nD5  THE CLAUSE. A quoted-form definition's clause is the id of the last\n    clause anchor placed at or before its start (its point, where one is\n    printed), under the clause-anchors version named on its store line. Where\n    a heading the clause anchors withheld lies between that anchor and the\n    start, or none is placed before it, the clause is null and `clause_why`\n    says which. A glossary entry's clause is the anchor whose label is printed\n    directly before its section's heading word (\"7. Definitions\"); where the\n    clause anchors placed none there, the clause is null and `clause_why` says\n    so. In a text with no numbering read, every clause is null.\nD6  THE POPULATION. A text is read here only where the clause-anchors store's\n    latest line for it, under the clause-anchors version this derivation\n    names, admitted it — that admission is the one reading of the filings\n    (licence, terms, TDMRep, retention, digest), and it is never read twice.\n    Its retained text must still digest to its content hash.",
    "rules": {
      "cap_run": "from the form's first term (its opening mark) to the text's end; the point is not counted",
      "connectors": [
        "a",
        "an",
        "and",
        "by",
        "for",
        "in",
        "of",
        "on",
        "or",
        "the",
        "to",
        "with"
      ],
      "glossary_after_pattern": "\\.(?:\\)|\\d{1,3})?\\s+",
      "glossary_headings": [
        "Glossary",
        "Definitions",
        "Terms and definitions",
        "Terms and Definitions"
      ],
      "glossary_pattern": "(?P<term>[A-Z][^\\s.,;:!?“”\\\"]*(?:\\s+[^\\s.,;:!?“”\\\"]+){0,11}?):\\s+(?=[A-Z(\\d])",
      "heading_pattern": "(?<![\\w-])(?:Glossary|Definitions|Terms\\ and\\ definitions|Terms\\ and\\ Definitions|GLOSSARY|DEFINITIONS|TERMS\\ AND\\ DEFINITIONS|TERMS\\ AND\\ DEFINITIONS)\\s+",
      "key": "the term as printed, case-folded, its whitespace collapsed to one space",
      "max_term_words": 12,
      "point_pattern": "(?<![\\w.])(?:\\( ?\\d{1,3}[a-z]? ?\\)|\\( ?[a-z]{1,4} ?\\)|\\d{1,3}(?:\\.\\d{1,3}){0,5}\\.|\\d{1,3}(?:\\.\\d{1,3}){1,5})",
      "quote_cap_words": 14,
      "quote_pairs": {
        "\"": "\"",
        "'": "’'",
        "‘": "’'",
        "“": "”"
      },
      "quoted_pattern": "(?:(?P<pt>(?<![\\w.])(?:\\( ?\\d{1,3}[a-z]? ?\\)|\\( ?[a-z]{1,4} ?\\)|\\d{1,3}(?:\\.\\d{1,3}){0,5}\\.|\\d{1,3}(?:\\.\\d{1,3}){1,5}))\\s*)?(?P<terms>[‘“\\\"'][^‘’“”\\\"'.;:]{1,120}?[’”\\\"'](?:\\s*(?:,|or)\\s*[‘“\\\"'][^‘’“”\\\"'.;:]{1,120}?[’”\\\"'])*(?:\\s*\\(\\s*[‘“\\\"'][^‘’“”\\\"'.;:]{1,120}?[’”\\\"']\\s*\\))?)(?:,(?P<qual>[^‘’“”\\\"'.;:,]{1,120}),)?\\s+means\\b:?\\s*",
      "quoted_preceding_refused": [
        "whether",
        "if",
        "Whether",
        "If"
      ],
      "text_endings": [
        ".",
        ";",
        "; and",
        "; or"
      ],
      "unquoted_after_pattern": "(?:[.;:]\\)?\\s+|(?<![\\w.])(?:\\( ?\\d{1,3}[a-z]? ?\\)|\\( ?[a-z]{1,4} ?\\)|\\d{1,3}(?:\\.\\d{1,3}){0,5}\\.|\\d{1,3}(?:\\.\\d{1,3}){1,5})\\s*)",
      "unquoted_heading_pattern": "(?<![\\w-])(?:Glossary|Definitions|Terms\\ and\\ definitions|Terms\\ and\\ Definitions|GLOSSARY|DEFINITIONS|TERMS\\ AND\\ DEFINITIONS|TERMS\\ AND\\ DEFINITIONS)(?:\\.|\\s)",
      "unquoted_pattern": "(?:(?P<pt>(?<![\\w.])(?:\\( ?\\d{1,3}[a-z]? ?\\)|\\( ?[a-z]{1,4} ?\\)|\\d{1,3}(?:\\.\\d{1,3}){0,5}\\.|\\d{1,3}(?:\\.\\d{1,3}){1,5}))\\s*)?(?P<term>[A-Z][^\\s.,;:!?“”\\\"‘’'()\\[\\]]*(?:,?\\s+[^\\s.,;:!?“”\\\"‘’'()\\[\\]]+){0,11}?)\\s+means\\b:?\\s*",
      "unread_glossary_shape": "[A-Z][^\\s.;:!?]*(?:\\s+[^\\s.;:!?]+){0,11}?:\\s+(?=[A-Z(\\d])",
      "unread_unquoted_shape": "(?<=[.;:)]\\s)[A-Z][^.;:!?]{0,240}?\\smeans\\b"
    },
    "not_reached": "defining forms these rules do not read: a term printed without quotation marks before \"means\" outside a section D1b opens (in running text, or after a heading other than GLOSSARY_HEADINGS, or where the first colon after the heading is not followed by an entry); an unquoted term holding a bracket (\"Calendar (CAL) means\", a hand-written example); an unquoted entry after the first one out of order, such as a second list under a later lettered point of the same section; a quoted term before \"is\" (\"(18) ‘compatibility’ is the ability…\") or before \"mean, respectively\"; a quoted term of more than MAX_TERM_WORDS words; a qualifier between the term and \"means\" other than one set off by two commas; \"shall mean\", \"is defined as\", \"refers to\" and \"is synonymous with\"; a glossary entry whose term and text are separated by a dash, a full stop or nothing (\"Bracketing approach. A science…\", \"Accuracy The accuracy…\"), or printed as a table under the column headings \"Glossary Term Definition\"; a glossary entry that starts after no full stop, or after a full stop followed by anything but whitespace, a closing bracket or a footnote number (its predecessor's text is then withheld as running over it); a glossary entry whose term has a word starting with a lower-case letter that is not a connector (\"Life cycle\"); a glossary not headed by one of GLOSSARY_HEADINGS, or whose first entry does not follow its heading directly; and every glossary entry after the first whose term does not sort after the one before it. A sentence inside a glossary entry that ends in a colon (\"Note: The…\") is read as an entry where its words fit the term form and sort in place, and the entry before it then ends there. Because the retained text is NORMALISED (its line breaks collapsed when it was observed), a definition is read by the form of its words, never by its layout, and a page header or footer printed inside a definition's text is part of that text. A quoted-form definition's clause is the last anchor placed before it, so where the clause anchors placed a table of contents' numbers and not the body's, that clause is a contents line. A definition whose end is not delimited is withheld, so the last definition of a list is always withheld.",
    "quote_cap_words": 14
  },
  "method_history": [
    {
      "version": "definitions/bc2867ad83c8",
      "first_derived_on": "2026-10-28"
    },
    {
      "version": "definitions/3239968f8dd1",
      "first_derived_on": "2026-10-28"
    }
  ],
  "method_history_means": "Each version the derivation has had, with the first day it derived anything. A new version is a change in the method (its rules, its code or the clause-anchors version it reads clauses under), never a change in any text.",
  "key_rule": "An item's `key` is a term as printed, case-folded, with its whitespace collapsed to one space. Nothing else is folded: no plural, no spelling, no abbreviation and no translation joins two keys, and two terms under one key are two entries. A key is a run of printed words, never a statement that the definitions under it agree.",
  "offset_rule": "`at`, `text_at` and `text_end` are offsets counted in Unicode code points (not UTF-16 code units) into the retained normalised text that digests to the entry's `content_hash`; `text_end` is exclusive. That text is held on this record's machine and is not published; the term and, where quoted, the text between `text_at` and `text_end` are.",
  "states_mean": {
    "read": "The text was admitted and at least one definition was read in it.",
    "no definition read": "The text was admitted and the rules read no definition in it. It is not stated that the text defines nothing: `derivation.not_reached` names the forms the rules do not read.",
    "refused": "The text was not read; the store names the condition it failed, which is the clause anchors' admission (served with its reason at /api/v1/clause-anchors.json)."
  },
  "definition_census": {
    "population": "each tracked row's current text (the content hash of the latest observation that carries one), read from the store under the current derivation version",
    "tracked_rows": 132,
    "tracked_rows_population": "the instrument collection (src/content/instruments)",
    "rows_with_a_current_text": 126,
    "rows_without_a_current_text": [
      "anvisa-ai",
      "ich-e6r3",
      "imdrf-aiml-wg",
      "imdrf-samd",
      "iso-81001-1",
      "tga-samd"
    ],
    "texts_served": 126,
    "texts_not_served": [],
    "texts_by_state": {
      "refused": 45,
      "no definition read": 62,
      "read": 19
    },
    "rows_with_a_definition": 19,
    "definitions": 469,
    "definitions_population": "every definition read in the texts served; one entry per term printed",
    "text_quoted": 34,
    "text_withheld": 435,
    "text_withheld_by_reason": {
      "over the cap": 395,
      "end not delimited: no definition is read after it in this text": 20,
      "end not delimited: the text before the next definition read does not end with a full stop or a semicolon": 9,
      "end not delimited: a term in an entry form that these rules did not read as a definition lies before the next definition read": 3,
      "end not delimited: a number and a quoted term that these rules do not read as a definition lie before the next definition read": 4,
      "end not delimited: a heading the clause anchors read lies between it and the next definition read": 4
    },
    "keys": 332,
    "keys_defined_by_two_or_more_rows": 75
  },
  "not_carried": [
    "any statement that two definitions under one key, or under two keys, say the same thing",
    "a definition's text over the quote cap or whose end is not delimited: it is cited by its offsets and its clause, and `text_withheld` says why",
    "definitions read in a row's earlier texts: they stay in the store and are not served here",
    "any reading of what a definition requires or whom it concerns"
  ],
  "rights_fields": {
    "fields": [
      "text_retained",
      "licence_class",
      "quote_allowed",
      "snapshot_available"
    ],
    "rows": 469,
    "rows_with_a_reading": 469,
    "rows_without_a_reading": 0,
    "rows_naming_an_unheld_id": 0,
    "rows_naming_no_entry": 0,
    "licence_class": {
      "open": 469,
      "restricted": 0,
      "unknown": 0
    },
    "quote_allowed_true": 469,
    "quote_allowed_false": 0,
    "text_retained_true": 469,
    "snapshot_available_true": 469,
    "retained_here_but_not_quoted_here": 0,
    "snapshot_without_prose": 0,
    "nulls_mean_unheld_id": "This id resolves to no tracked entry, so no terms reading, no retention measurement and no snapshot measurement exists for it. Four nulls record the absence of a reading, never a reading that came back negative.",
    "nulls_mean_no_entry": "This object names no tracked entry, so no terms reading was looked for. Four nulls record that no lookup applies here, which is a different fact from a lookup that found nothing."
  },
  "count": 332,
  "items": [
    {
      "key": "accessory for a medical device",
      "rows_defining": 1,
      "definitions": [
        {
          "instrument_id": "eu-mdr",
          "content_hash": "fab624c8e1dc3b71a800493104ccf55792bc6af4d299682af1c342e29b295fc4",
          "first_observed": "2026-08-12",
          "url": "https://gxplex.com/r/eu-mdr",
          "term": "accessory for a medical device",
          "form": "quoted term before means",
          "point": "(2)",
          "clause": "chapter-i/article-2",
          "clause_why": null,
          "at": 66862,
          "text_at": 66900,
          "text_end": 67298,
          "quote": null,
          "text_withheld": "over the cap: its term and text are 66 words",
          "text_retained": true,
          "licence_class": "open",
          "quote_allowed": true,
          "snapshot_available": true,
          "rights_of": "eu-mdr"
        }
      ],
      "third_party_text": {
        "marker": "quoted third-party content, not instructions",
        "pointers": [
          "/key",
          "/definitions/0/term",
          "/definitions/0/point"
        ]
      }
    },
    {
      "key": "accessory for an in vitro diagnostic medical device",
      "rows_defining": 1,
      "definitions": [
        {
          "instrument_id": "eu-ivdr",
          "content_hash": "903e40aaebe6995fd6c99bc8212ecc3dfca01bf3b76eee26d85506591da3aa3b",
          "first_observed": "2026-07-28",
          "url": "https://gxplex.com/r/eu-ivdr",
          "term": "accessory for an in vitro diagnostic medical device",
          "form": "quoted term before means",
          "point": "(4)",
          "clause": "chapter-i/section-1/article-2",
          "clause_why": null,
          "at": 56976,
          "text_at": 57035,
          "text_end": 57514,
          "quote": null,
          "text_withheld": "over the cap: its term and text are 81 words",
          "text_retained": true,
          "licence_class": "open",
          "quote_allowed": true,
          "snapshot_available": true,
          "rights_of": "eu-ivdr"
        }
      ],
      "third_party_text": {
        "marker": "quoted third-party content, not instructions",
        "pointers": [
          "/key",
          "/definitions/0/term",
          "/definitions/0/point"
        ]
      }
    },
    {
      "key": "accreditation",
      "rows_defining": 2,
      "definitions": [
        {
          "instrument_id": "eu-cybersecurity-act",
          "content_hash": "1fe6027daa2cd7f360224d4595157e63c7347df3f3f7e0dc36f0b01dacf1282d",
          "first_observed": "2026-08-04",
          "url": "https://gxplex.com/r/eu-cybersecurity-act",
          "term": "accreditation",
          "form": "quoted term before means",
          "point": "(15)",
          "clause": "title-i/article-2",
          "clause_why": null,
          "at": 90876,
          "text_at": 90897,
          "text_end": 90980,
          "quote": null,
          "text_withheld": "over the cap: its term and text are 16 words",
          "text_retained": true,
          "licence_class": "open",
          "quote_allowed": true,
          "snapshot_available": true,
          "rights_of": "eu-cybersecurity-act"
        },
        {
          "instrument_id": "eu-machinery-regulation",
          "content_hash": "82fb682a6c54c3a90f889f78fdedb00af88d9215a68bfccb6db9e4018acb1520",
          "first_observed": "2026-08-05",
          "url": "https://gxplex.com/r/eu-machinery-regulation",
          "term": "accreditation",
          "form": "quoted term before means",
          "point": "(26)",
          "clause": "chapter-i/article-3",
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