Textual twins
Medical Devices Regulation Art. 80 and IVDR Art. 76 where the texts differ
textually similar (0.923) · paired on the Medical Devices Regulation text of 19 July 2026 and the IVDR text of 10 January 2025 · headings different
Medical Devices Regulation Art. 80 and IVDR Art. 76 are textually similar: their words match at a ratio of 0.923, where 1 is identical text. That says nothing about what either provision requires, or whether one should change because the other did.
Medical Devices Regulation Art. 80 on EUR-Lex (external, EUR-Lex) · IVDR Art. 76 on EUR-Lex (external, EUR-Lex)
Where the texts differ
Each passage is a differing span with up to 6 unchanged words either side, from the text as compared, spacing collapsed, and cut at 400 characters where it ends […]. It is an excerpt for reading where the two differ, not the verbatim text.
| Passage | Medical Devices Regulation Art. 80 | IVDR Art. 76 |
|---|---|---|
| 1 | Article 80 Recording and reporting of adverse events | Article 76 Recording and reporting of adverse events |
| 2 | of adverse events that occur during clinical investigations 1. The sponsor shall fully record | of adverse events that occur during performance studies 1. The sponsor shall fully record |
| 3 | of a type identified in the clinical investigation plan as being critical to the | of a type identified in the performance study plan as being critical to the |
| 4 | evaluation of the results of that clinical investigation; (b) any serious adverse event; (c) | evaluation of the results of that performance study; (b) any serious adverse event; (c) |
| 5 | to (c). 2. The sponsor shall report, without delay to all Member States | to (c). 2. The sponsor shall report without delay to all Member States |
| 6 | to all Member States in which the clinical investigation is being conducted, all of the | to all Member States in which a performance study is being conducted all of the |
| 7 | which the clinical investigation is being conducted, all of the following by means | which a performance study is being conducted all of the following by means |
| 8 | electronic system referred to in Article 73: (a) any serious adverse event that | electronic system referred to in Article 69: (a) any serious adverse event that |
| 9 | has a causal relationship with the investigational device, the comparator or the investigation | has a causal relationship with the device, the comparator or the study |
| 10 | investigational device, the comparator or the investigation procedure or where such causal relationship | the device, the comparator or the study procedure or where such causal relationship |
| 11 | any Member State in which the clinical investigation is being conducted, the sponsor shall | any Member State in which the performance study is being conducted, the sponsor shall |
| 12 | the Member States in which the clinical investigation is being conducted any event referred | the Member States in which the performance study is being conducted any event referred |
18 more passages not shown; read both on EUR-Lex.
Aligned sub-provisions
Medical Devices Regulation first, then IVDR, each with its word ratio.
- Art. 80(1) and Art. 76(1) · 0.954
- Art. 80(1)(1) and Art. 76(1)(1) · 0.953
- Art. 80(1)(1)(b) and Art. 76(1)(1)(b) · 1.000
- Art. 80(1)(1)(c) and Art. 76(1)(1)(c) · 1.000
- Art. 80(1)(1)(d) and Art. 76(1)(1)(d) · 1.000
- Art. 80(2) and Art. 76(2) · 0.943
- Art. 80(2)(1) and Art. 76(2)(1) · 0.930
- Art. 80(2)(1)(a) and Art. 76(2)(1)(a) · 0.945
- Art. 80(2)(1)(b) and Art. 76(2)(1)(b) · 1.000
- Art. 80(2)(1)(c) and Art. 76(2)(1)(c) · 1.000
- Art. 80(2)(2) and Art. 76(2)(2) · 1.000
- Art. 80(2)(3) and Art. 76(2)(3) · 0.920
- Art. 80(4) and Art. 76(4) · 0.939
- Art. 80(4)(1) and Art. 76(4)(1) · 0.910
- Art. 80(4)(3) and Art. 76(4)(3) · 1.000
- Art. 80(6) and Art. 76(6) · 0.920
- Art. 80(6)(1) and Art. 76(6)(1) · 0.917
Changes since the texts were paired
The record holds no change to either provision after the versions they were paired on.