Textual twins
Medical Devices Regulation Art. 87 and IVDR Art. 82 where the texts differ
textually similar (0.965) · paired on the Medical Devices Regulation text of 19 July 2026 and the IVDR text of 10 January 2025 · headings the same
Medical Devices Regulation Art. 87 and IVDR Art. 82 are textually similar: their words match at a ratio of 0.965, 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. 87 on EUR-Lex (external, EUR-Lex) · IVDR Art. 82 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. 87 | IVDR Art. 82 |
|---|---|---|
| 1 | Article 87 Reporting of serious incidents and field | Article 82 Reporting of serious incidents and field |
| 2 | safety corrective actions 1. Manufacturers of devices made available on the Union market, | safety corrective actions 1. Manufacturers of devices, made available on the Union market, |
| 3 | on the Union market, other than investigational devices, shall report, to the relevant competent | on the Union market, other than devices for performance study, shall report, to the relevant competent |
| 4 | competent authorities, in accordance with Articles 92(5) and (7), the following: (a) any | competent authorities, in accordance with Articles 87(5) and (7), the following: (a) any |
| 5 | on the Union market, except expected side-effects which are clearly documented in the | on the Union market, except expected erroneous results which are clearly documented and quantified |
| 6 | expected side-effects which are clearly documented in the product information and quantified | erroneous results which are clearly documented and quantified in the product information and in |
| 7 | documented in the product information and quantified in the technical documentation and are | quantified in the product information and in the technical documentation and are |
| 8 | to trend reporting pursuant to Article 88; (b) any field safety corrective action | to trend reporting pursuant to Article 83; (b) any field safety corrective action |
| 9 | electronic system referred to in Article 92. 2. As a general rule, the | electronic system referred to in Article 87. 2. As a general rule, the |
| 10 | as referred to in point (a) of paragraph 1 immediately after they have established the | as referred to in point (a) immediately after they have established a |
| 11 | 1 immediately after they have established the causal relationship between that incident and | (a) immediately after they have established a causal relationship between that incident and |
| 12 | that such causal relationship is reasonably possible and not later than 15 days | that such causal relationship is reasonably possible, and not later than 15 days |
13 more passages not shown; read both on EUR-Lex.
Aligned sub-provisions
Medical Devices Regulation first, then IVDR, each with its word ratio.
- Art. 87(1) and Art. 82(1) · 0.935
- Art. 87(1)(1) and Art. 82(1)(1) · 0.932
- Art. 87(1)(1)(a) and Art. 82(1)(1)(a) · 0.900
- Art. 87(1)(1)(b) and Art. 82(1)(1)(b) · 1.000
- Art. 87(1)(2) and Art. 82(1)(2) · 0.950
- Art. 87(2) and Art. 82(2) · 1.000
- Art. 87(2)(1) and Art. 82(2)(1) · 1.000
- Art. 87(3) and Art. 82(3) · 0.929
- Art. 87(3)(1) and Art. 82(3)(1) · 0.928
- Art. 87(4) and Art. 82(4) · 1.000
- Art. 87(4)(1) and Art. 82(4)(1) · 1.000
- Art. 87(5) and Art. 82(5) · 1.000
- Art. 87(5)(1) and Art. 82(5)(1) · 1.000
- Art. 87(6) and Art. 82(6) · 1.000
- Art. 87(6)(1) and Art. 82(6)(1) · 1.000
- Art. 87(7) and Art. 82(7) · 1.000
- Art. 87(7)(1) and Art. 82(7)(1) · 1.000
- Art. 87(8) and Art. 82(8) · 0.979
- Art. 87(8)(1) and Art. 82(8)(1) · 0.979
- Art. 87(9) and Art. 82(9) · 0.960
- Art. 87(9)(1) and Art. 82(9)(1) · 0.959
- Art. 87(10) and Art. 82(10) · 1.000
- Art. 87(10)(1) and Art. 82(10)(1) · 1.000
- Art. 87(10)(2) and Art. 82(10)(2) · 1.000
- Art. 87(11) and Art. 82(11) · 0.959
- Art. 87(11)(1) and Art. 82(11)(1) · 1.000
- Art. 87(11)(2) and Art. 82(11)(2) · 0.983
- Art. 87(11)(3) and Art. 82(11)(3) · 0.919
Changes since the texts were paired
The record holds no change to either provision after the versions they were paired on.