# Evidence packet — MHRA AI

Generated 2026-09-18. Packet version 1.
Published at https://gxplex.com/packet/mhra-ai

This packet reports what a publisher published and when this record observed it. It carries no assessment of what the document requires and no reading of what any change means.

## Source

| field | value |
| --- | --- |
| id | mhra-ai |
| title | MHRA publications on AI and software as a medical device |
| jurisdiction | UK |
| source url (asked) | https://www.gov.uk/government/publications/software-and-artificial-intelligence-ai-as-a-medical-device |
| answered url | https://www.gov.uk/government/publications/software-and-artificial-intelligence-ai-as-a-medical-device |
| observed cadence | monthly |
| row | https://gxplex.com/r/mhra-ai |

## Publisher

| field | value |
| --- | --- |
| authority | Medicines and Healthcare products Regulatory Agency |
| origin host | — |
| origin citation | — |
| standards body | — |
| standards body citation | — |

No origin host is recorded for this row. The authority named above is the body; the host is a fact about which origin answered, and this row does not carry one.

## Type

| field | value |
| --- | --- |
| class as stated by the publisher | — |
| read from | — |
| source kind, recorded here | document |
| source type, recorded here | document |
| record tier | core |

No class statement by the publisher is recorded for this row, so this packet states none. That is an absent reading rather than a document without a class.

## Lifecycle

| field | value |
| --- | --- |
| status | final |
| status qualifier | — |
| status as of | — |
| effective date | — |
| last changed | — |
| status read from | — |
| status withdrawn | — |
| status withdrawn on | — |
| decay class | live |
| frozen reason | — |

These are the dates the record holds for this document's own status. They state nothing about which products or activities the document reaches.

## Verification

| field | value |
| --- | --- |
| state | ● verified |
| what the state states | checked against the primary source by a person |
| checked by | human |
| check date | 2026-07-30 |
| last verified | 2026-07-30 |

## Terms

| field | value |
| --- | --- |
| licence class | open |
| text retained here | yes |
| quotation appears in this record | yes |
| snapshot retained here | yes |

## Observations with retained text

| first seen | seq | days | digest | class | answered at | bytes |
| --- | --- | --- | --- | --- | --- | --- |
| 2026-07-30 | 5 | 44 | 110d6c8e7c56695c1d9d6e142f6bbef244d128fd9a9a43aac8178a00bfdb04d2 | document | https://www.gov.uk/government/publications/software-and-artificial-intelligence-ai-as-a-medical-device | 3134 |
| 2026-09-08 | 1 | 1 | d4b6bb0450a88d7f3c23a74b60b24949f0dd71b7d974a7fb09f142095c33384b | document | https://www.gov.uk/government/publications/software-and-artificial-intelligence-ai-as-a-medical-device | 3181 |
| 2026-09-09 | 1 | 1 | 0d4b2abb3a4fdc70b67096c0eafb5ed0e5dfa726bbdbfcb5797a712757b30aac | document | https://www.gov.uk/government/publications/software-and-artificial-intelligence-ai-as-a-medical-device | 3181 |
| 2026-09-10 | 1 | 1 | 8fc70fdfe3a5f042bff55fa7c11a67c77b2f13f76b6f8eec3000728700c089c2 | document | https://www.gov.uk/government/publications/software-and-artificial-intelligence-ai-as-a-medical-device | 3181 |
| 2026-09-11 | 1 | 1 | 95ff73c7efa26058465bf11ac1d968a97a02f9c9915ae31e4fa989a914853f7a | document | https://www.gov.uk/government/publications/software-and-artificial-intelligence-ai-as-a-medical-device | 3181 |
| 2026-09-12 | 1 | 1 | 21fde7c052b400702464b718b815337971e5757ea8ed070bfbd569dafc49b35d | document | https://www.gov.uk/government/publications/software-and-artificial-intelligence-ai-as-a-medical-device | 3181 |
| 2026-09-13 | 1 | 1 | d722379e4120a9c4c8f76d1bb52c7a08e79bd5af11d92ac6ba69c1b31cde2403 | document | https://www.gov.uk/government/publications/software-and-artificial-intelligence-ai-as-a-medical-device | 3181 |
| 2026-09-14 | 1 | 1 | f61cf3af50631aaf06a7a9d0cb561121fc90f598cf503b9a402dc4393c643fec | document | https://www.gov.uk/government/publications/software-and-artificial-intelligence-ai-as-a-medical-device | 3181 |

Digests recorded: 8. With retained text: 8. Without: 0. Series state: comparable.

These readings interleave: at least one digest was observed again after a later one had already appeared, so they are the digests this record has seen, in the order it first saw each, and not a sequence of versions.

## Changes

One entry per consecutive pair of retained readings, in the order this record first saw each digest. Every entry carries a measured difference or the first condition that refused one. A refused entry was never tested against the conditions after it.

| from | to | verdict | condition | words | exact |
| --- | --- | --- | --- | --- | --- |
| 2026-07-30#5 | 2026-09-08#1 | difference | — | 4 | yes |
| 2026-09-08#1 | 2026-09-09#1 | difference | — | 2 | yes |
| 2026-09-09#1 | 2026-09-10#1 | difference | — | 2 | yes |
| 2026-09-10#1 | 2026-09-11#1 | difference | — | 2 | yes |
| 2026-09-11#1 | 2026-09-12#1 | difference | — | 2 | yes |
| 2026-09-12#1 | 2026-09-13#1 | difference | — | 2 | yes |
| 2026-09-13#1 | 2026-09-14#1 | difference | — | 2 | yes |

### 2026-07-30#5 → 2026-09-08#1

| field | value |
| --- | --- |
| earlier digest | 110d6c8e7c56695c1d9d6e142f6bbef244d128fd9a9a43aac8178a00bfdb04d2 |
| later digest | d4b6bb0450a88d7f3c23a74b60b24949f0dd71b7d974a7fb09f142095c33384b |
| earlier answered at | https://www.gov.uk/government/publications/software-and-artificial-intelligence-ai-as-a-medical-device |
| later answered at | https://www.gov.uk/government/publications/software-and-artificial-intelligence-ai-as-a-medical-device |
| verdict | difference |
| condition | — |
| condition kind | — |
| words differing | 4 |
| figure is exact | yes |
| words removed | 0 |
| words added | 4 |
| the words that differ, published at | https://gxplex.com/compare/mhra-ai#cmp-2026-07-30-5-2026-09-08-1 |

### 2026-09-08#1 → 2026-09-09#1

| field | value |
| --- | --- |
| earlier digest | d4b6bb0450a88d7f3c23a74b60b24949f0dd71b7d974a7fb09f142095c33384b |
| later digest | 0d4b2abb3a4fdc70b67096c0eafb5ed0e5dfa726bbdbfcb5797a712757b30aac |
| earlier answered at | https://www.gov.uk/government/publications/software-and-artificial-intelligence-ai-as-a-medical-device |
| later answered at | https://www.gov.uk/government/publications/software-and-artificial-intelligence-ai-as-a-medical-device |
| verdict | difference |
| condition | — |
| condition kind | — |
| words differing | 2 |
| figure is exact | yes |
| words removed | 1 |
| words added | 1 |
| the words that differ, published at | https://gxplex.com/compare/mhra-ai#cmp-2026-09-08-1-2026-09-09-1 |

### 2026-09-09#1 → 2026-09-10#1

| field | value |
| --- | --- |
| earlier digest | 0d4b2abb3a4fdc70b67096c0eafb5ed0e5dfa726bbdbfcb5797a712757b30aac |
| later digest | 8fc70fdfe3a5f042bff55fa7c11a67c77b2f13f76b6f8eec3000728700c089c2 |
| earlier answered at | https://www.gov.uk/government/publications/software-and-artificial-intelligence-ai-as-a-medical-device |
| later answered at | https://www.gov.uk/government/publications/software-and-artificial-intelligence-ai-as-a-medical-device |
| verdict | difference |
| condition | — |
| condition kind | — |
| words differing | 2 |
| figure is exact | yes |
| words removed | 1 |
| words added | 1 |
| the words that differ, published at | https://gxplex.com/compare/mhra-ai#cmp-2026-09-09-1-2026-09-10-1 |

### 2026-09-10#1 → 2026-09-11#1

| field | value |
| --- | --- |
| earlier digest | 8fc70fdfe3a5f042bff55fa7c11a67c77b2f13f76b6f8eec3000728700c089c2 |
| later digest | 95ff73c7efa26058465bf11ac1d968a97a02f9c9915ae31e4fa989a914853f7a |
| earlier answered at | https://www.gov.uk/government/publications/software-and-artificial-intelligence-ai-as-a-medical-device |
| later answered at | https://www.gov.uk/government/publications/software-and-artificial-intelligence-ai-as-a-medical-device |
| verdict | difference |
| condition | — |
| condition kind | — |
| words differing | 2 |
| figure is exact | yes |
| words removed | 1 |
| words added | 1 |
| the words that differ, published at | https://gxplex.com/compare/mhra-ai#cmp-2026-09-10-1-2026-09-11-1 |

### 2026-09-11#1 → 2026-09-12#1

| field | value |
| --- | --- |
| earlier digest | 95ff73c7efa26058465bf11ac1d968a97a02f9c9915ae31e4fa989a914853f7a |
| later digest | 21fde7c052b400702464b718b815337971e5757ea8ed070bfbd569dafc49b35d |
| earlier answered at | https://www.gov.uk/government/publications/software-and-artificial-intelligence-ai-as-a-medical-device |
| later answered at | https://www.gov.uk/government/publications/software-and-artificial-intelligence-ai-as-a-medical-device |
| verdict | difference |
| condition | — |
| condition kind | — |
| words differing | 2 |
| figure is exact | yes |
| words removed | 1 |
| words added | 1 |
| the words that differ, published at | https://gxplex.com/compare/mhra-ai#cmp-2026-09-11-1-2026-09-12-1 |

### 2026-09-12#1 → 2026-09-13#1

| field | value |
| --- | --- |
| earlier digest | 21fde7c052b400702464b718b815337971e5757ea8ed070bfbd569dafc49b35d |
| later digest | d722379e4120a9c4c8f76d1bb52c7a08e79bd5af11d92ac6ba69c1b31cde2403 |
| earlier answered at | https://www.gov.uk/government/publications/software-and-artificial-intelligence-ai-as-a-medical-device |
| later answered at | https://www.gov.uk/government/publications/software-and-artificial-intelligence-ai-as-a-medical-device |
| verdict | difference |
| condition | — |
| condition kind | — |
| words differing | 2 |
| figure is exact | yes |
| words removed | 1 |
| words added | 1 |
| the words that differ, published at | https://gxplex.com/compare/mhra-ai#cmp-2026-09-12-1-2026-09-13-1 |

### 2026-09-13#1 → 2026-09-14#1

| field | value |
| --- | --- |
| earlier digest | d722379e4120a9c4c8f76d1bb52c7a08e79bd5af11d92ac6ba69c1b31cde2403 |
| later digest | f61cf3af50631aaf06a7a9d0cb561121fc90f598cf503b9a402dc4393c643fec |
| earlier answered at | https://www.gov.uk/government/publications/software-and-artificial-intelligence-ai-as-a-medical-device |
| later answered at | https://www.gov.uk/government/publications/software-and-artificial-intelligence-ai-as-a-medical-device |
| verdict | difference |
| condition | — |
| condition kind | — |
| words differing | 2 |
| figure is exact | yes |
| words removed | 1 |
| words added | 1 |
| the words that differ, published at | https://gxplex.com/compare/mhra-ai#cmp-2026-09-13-1-2026-09-14-1 |


## Integrity

| field | value |
| --- | --- |
| root | fd0980cf7ca42518ff7457b92b075df16163772d48d6f75e546b4869fe7bedab |
| leaves the root covers | 5393 |
| algorithm | SHA-256 over sorted `id\|date\|content_hash` lines, pairwise; an odd final node is promoted, never doubled. |
| fixed on | 2026-09-18 |
| root published at | https://gxplex.com/integrity/root.txt |
| leaves published at | https://gxplex.com/integrity/leaves.txt |
| the commands | https://gxplex.com/verify |
| leaf lines for this row | 51 |

The root is over every leaf line the record holds, not over the lines below. Reducing it needs the published file, which is served whole at the address named here together with the command that reduces it. These lines are this row's own slice of that file, copied verbatim.

```
mhra-ai|2026-07-30|110d6c8e7c56695c1d9d6e142f6bbef244d128fd9a9a43aac8178a00bfdb04d2
mhra-ai|2026-07-31|110d6c8e7c56695c1d9d6e142f6bbef244d128fd9a9a43aac8178a00bfdb04d2
mhra-ai|2026-08-01|110d6c8e7c56695c1d9d6e142f6bbef244d128fd9a9a43aac8178a00bfdb04d2
mhra-ai|2026-08-02|110d6c8e7c56695c1d9d6e142f6bbef244d128fd9a9a43aac8178a00bfdb04d2
mhra-ai|2026-08-03|110d6c8e7c56695c1d9d6e142f6bbef244d128fd9a9a43aac8178a00bfdb04d2
mhra-ai|2026-08-04|110d6c8e7c56695c1d9d6e142f6bbef244d128fd9a9a43aac8178a00bfdb04d2
mhra-ai|2026-08-05|110d6c8e7c56695c1d9d6e142f6bbef244d128fd9a9a43aac8178a00bfdb04d2
mhra-ai|2026-08-06|110d6c8e7c56695c1d9d6e142f6bbef244d128fd9a9a43aac8178a00bfdb04d2
mhra-ai|2026-08-07|110d6c8e7c56695c1d9d6e142f6bbef244d128fd9a9a43aac8178a00bfdb04d2
mhra-ai|2026-08-08|110d6c8e7c56695c1d9d6e142f6bbef244d128fd9a9a43aac8178a00bfdb04d2
mhra-ai|2026-08-09|110d6c8e7c56695c1d9d6e142f6bbef244d128fd9a9a43aac8178a00bfdb04d2
mhra-ai|2026-08-10|110d6c8e7c56695c1d9d6e142f6bbef244d128fd9a9a43aac8178a00bfdb04d2
mhra-ai|2026-08-11|110d6c8e7c56695c1d9d6e142f6bbef244d128fd9a9a43aac8178a00bfdb04d2
mhra-ai|2026-08-12|110d6c8e7c56695c1d9d6e142f6bbef244d128fd9a9a43aac8178a00bfdb04d2
mhra-ai|2026-08-13|110d6c8e7c56695c1d9d6e142f6bbef244d128fd9a9a43aac8178a00bfdb04d2
mhra-ai|2026-08-14|110d6c8e7c56695c1d9d6e142f6bbef244d128fd9a9a43aac8178a00bfdb04d2
mhra-ai|2026-08-15|110d6c8e7c56695c1d9d6e142f6bbef244d128fd9a9a43aac8178a00bfdb04d2
mhra-ai|2026-08-16|110d6c8e7c56695c1d9d6e142f6bbef244d128fd9a9a43aac8178a00bfdb04d2
mhra-ai|2026-08-17|110d6c8e7c56695c1d9d6e142f6bbef244d128fd9a9a43aac8178a00bfdb04d2
mhra-ai|2026-08-18|110d6c8e7c56695c1d9d6e142f6bbef244d128fd9a9a43aac8178a00bfdb04d2
mhra-ai|2026-08-19|110d6c8e7c56695c1d9d6e142f6bbef244d128fd9a9a43aac8178a00bfdb04d2
mhra-ai|2026-08-20|110d6c8e7c56695c1d9d6e142f6bbef244d128fd9a9a43aac8178a00bfdb04d2
mhra-ai|2026-08-21|110d6c8e7c56695c1d9d6e142f6bbef244d128fd9a9a43aac8178a00bfdb04d2
mhra-ai|2026-08-22|110d6c8e7c56695c1d9d6e142f6bbef244d128fd9a9a43aac8178a00bfdb04d2
mhra-ai|2026-08-23|110d6c8e7c56695c1d9d6e142f6bbef244d128fd9a9a43aac8178a00bfdb04d2
mhra-ai|2026-08-24|110d6c8e7c56695c1d9d6e142f6bbef244d128fd9a9a43aac8178a00bfdb04d2
mhra-ai|2026-08-25|110d6c8e7c56695c1d9d6e142f6bbef244d128fd9a9a43aac8178a00bfdb04d2
mhra-ai|2026-08-26|110d6c8e7c56695c1d9d6e142f6bbef244d128fd9a9a43aac8178a00bfdb04d2
mhra-ai|2026-08-27|110d6c8e7c56695c1d9d6e142f6bbef244d128fd9a9a43aac8178a00bfdb04d2
mhra-ai|2026-08-28|110d6c8e7c56695c1d9d6e142f6bbef244d128fd9a9a43aac8178a00bfdb04d2
mhra-ai|2026-08-29|110d6c8e7c56695c1d9d6e142f6bbef244d128fd9a9a43aac8178a00bfdb04d2
mhra-ai|2026-08-30|110d6c8e7c56695c1d9d6e142f6bbef244d128fd9a9a43aac8178a00bfdb04d2
mhra-ai|2026-08-31|110d6c8e7c56695c1d9d6e142f6bbef244d128fd9a9a43aac8178a00bfdb04d2
mhra-ai|2026-09-01|110d6c8e7c56695c1d9d6e142f6bbef244d128fd9a9a43aac8178a00bfdb04d2
mhra-ai|2026-09-02|110d6c8e7c56695c1d9d6e142f6bbef244d128fd9a9a43aac8178a00bfdb04d2
mhra-ai|2026-09-03|110d6c8e7c56695c1d9d6e142f6bbef244d128fd9a9a43aac8178a00bfdb04d2
mhra-ai|2026-09-04|110d6c8e7c56695c1d9d6e142f6bbef244d128fd9a9a43aac8178a00bfdb04d2
mhra-ai|2026-09-05|110d6c8e7c56695c1d9d6e142f6bbef244d128fd9a9a43aac8178a00bfdb04d2
mhra-ai|2026-09-06|110d6c8e7c56695c1d9d6e142f6bbef244d128fd9a9a43aac8178a00bfdb04d2
mhra-ai|2026-09-07|110d6c8e7c56695c1d9d6e142f6bbef244d128fd9a9a43aac8178a00bfdb04d2
mhra-ai|2026-09-08|d4b6bb0450a88d7f3c23a74b60b24949f0dd71b7d974a7fb09f142095c33384b
mhra-ai|2026-09-09|0d4b2abb3a4fdc70b67096c0eafb5ed0e5dfa726bbdbfcb5797a712757b30aac
mhra-ai|2026-09-10|8fc70fdfe3a5f042bff55fa7c11a67c77b2f13f76b6f8eec3000728700c089c2
mhra-ai|2026-09-11|95ff73c7efa26058465bf11ac1d968a97a02f9c9915ae31e4fa989a914853f7a
mhra-ai|2026-09-12|21fde7c052b400702464b718b815337971e5757ea8ed070bfbd569dafc49b35d
mhra-ai|2026-09-13|d722379e4120a9c4c8f76d1bb52c7a08e79bd5af11d92ac6ba69c1b31cde2403
mhra-ai|2026-09-14|f61cf3af50631aaf06a7a9d0cb561121fc90f598cf503b9a402dc4393c643fec
mhra-ai|2026-09-15|110d6c8e7c56695c1d9d6e142f6bbef244d128fd9a9a43aac8178a00bfdb04d2
mhra-ai|2026-09-16|110d6c8e7c56695c1d9d6e142f6bbef244d128fd9a9a43aac8178a00bfdb04d2
mhra-ai|2026-09-17|110d6c8e7c56695c1d9d6e142f6bbef244d128fd9a9a43aac8178a00bfdb04d2
mhra-ai|2026-09-18|110d6c8e7c56695c1d9d6e142f6bbef244d128fd9a9a43aac8178a00bfdb04d2
```

## What this packet does not carry

- **the words that differ** — A count of a difference is in this packet; the words are not. They are a publisher's text, and this record checks borrowed text only on the surfaces it enumerates — a packet carrying spans under a key those checks do not read would be borrowed text nothing verifies. Each change names the comparison entry for the same pair, and says which of the two is at that address: the words, where a difference was measured and is inside the word ceiling; otherwise the same condition this entry names, with no text of the document.
- **this records own prose** — The row's summary and its account of an unresolved address are this archive's own voice. They are leads and not evidence, however accurate, because a faithful paraphrase is indistinguishable from evidence while remaining ours. They are published on the row's page and are not here.
- **any field that would characterise a change** — No score, no rank, no ordering by judgment, no reading of what a change means and no word for how much of it counts. A packet is evidence taken elsewhere, and a field characterising it would be an opinion with digests attached.
- **a recomputed root** — The integrity block states the root this record published and the leaf lines for this row. It computes no root of its own: two numbers this record produced, compared with each other, check nothing.

## The conditions, in the order they are evaluated

Counted over the 7 transition(s) above.

| condition | changes | what it states |
| --- | --- | --- |
| licence-restricted | none | No text from this document appears on this site, so no difference between two readings of it is shown either. The digests, the dates and the addresses are the record for this row. |
| licence-unread | none | No reading of the terms this source states is recorded for the row. That is an absent reading rather than an absent term, and the row is handled here exactly as a restricted one until a reading is recorded. |
| date-not-observed | not reached | No observation of this row on that day holds retained text. |
| date-not-unique | not reached | That day holds more than one distinct retained digest for this row, so a date alone does not name one observation. The addressed form — the day and the sequence within it — does. |
| one-point | not reached | Both dates resolve to the same observation. |
| referent-unclassified | none | The class of one of these observations could not be read, so neither was shown to be an observation of the document itself. |
| referent-class | none | One of these observations is not of the document. A listing page that names the document and the document are different subjects, and a difference between them is not a difference in the document. |
| referent-normalisation | none | These two digests were taken over different kinds of text — one over markup, one over prose extracted from a file — so the words they yield differ for a reason that is not the publisher’s. |
| referent-address | none | These two observations answered at different addresses. A difference between them is at least in part a difference between two pages. |
| text-not-retained | none | No normalised text is held here for one of these observations, so there is nothing on this side to compare. |
| snapshot-unreadable | none | Normalised text is recorded for one of these observations and could not be read from this record. |
| span-unverified | none | A span this comparison would have shown could not be found, word for word and in that order, in the retained text it was drawn from. The comparison is withheld rather than shown: a phrase assembled out of words a publisher did not write next to each other is a fabricated measurement of what the publisher wrote. |
| over-ceiling | none | A faithful difference is longer than the word ceiling this site publishes under. It is withheld whole rather than cut to fit: a shortened quote is a fabricated measurement of what a publisher wrote. The figures below are counts of the difference, not the difference. |

Three of the conditions belong to the form of the comparison that resolves two dates. Every comparison in this packet is formed from readings addressed by the key the store gives them, so those three are never evaluated here: their absence from the entries above records that they were not tested, rather than that they were tested and did not fire.

Word ceiling: 14.