Textual twins
Medical Devices Regulation Art. 89 and IVDR Art. 84 where the texts differ
textually similar (0.903) · 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. 89 and IVDR Art. 84 are textually similar: their words match at a ratio of 0.903, 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. 89 on EUR-Lex (external, EUR-Lex) · IVDR Art. 84 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. 89 | IVDR Art. 84 |
|---|---|---|
| 1 | Article 89 Analysis of serious incidents and field | Article 84 Analysis of serious incidents and field |
| 2 | a serious incident pursuant to Article 87(1), the manufacturer shall, without delay, perform | a serious incident pursuant to Article 82(1), the manufacturer shall, without delay, perform |
| 3 | the devices concerned. This shall include a risk assessment of the incident and | the devices concerned. This shall include risk assessment of the incident and |
| 4 | safety corrective action taking into account criteria as referred to in paragraph | safety corrective action taking into account the criteria as referred to in paragraph |
| 5 | their knowledge in accordance with Article 87 is evaluated centrally at national level | their knowledge in accordance with Article 82 is evaluated centrally at national level |
| 6 | reported serious incident and evaluate any related field safety corrective actions, taking into | reported serious incident and evaluate any field safety corrective actions, taking into |
| 7 | device, intended and potential users, and population affected. The competent authority shall | device, intended and potential users, and the population affected. The competent authority shall |
| 8 | national competent authority, manufacturers shall provide all documents necessary for the risk | national competent authority, manufacturers shall provide for all documents necessary for the risk |
| 9 | electronic system referred to in Article 92. The report shall set out conclusions | electronic system referred to in Article 87. The report shall set out conclusions |
| 10 | taken. 6. In the case of devices referred to in the first subparagraph of Article 1(8) and where the serious incident or field safety corrective action may be related to a substance which, if used separately, would be considered to be a medicinal product, the evaluating competent authority or the | taken. 6. In the case of companion diagnostic, the evaluating competent authority or the |
| 11 | paragraph 9 of this Article shall, inform the national competent authority or the | paragraph 9 of this Article shall, depending on whether the relevant competent authority of the |
| 12 | of this Article shall, inform the national competent authority or the EMA, depending | Article shall, depending on whether the relevant competent authority of the Member State |
11 more passages not shown; read both on EUR-Lex.
Aligned sub-provisions
Medical Devices Regulation first, then IVDR, each with its word ratio.
- Art. 89(1) and Art. 84(1) · 0.984
- Art. 89(1)(1) and Art. 84(1)(1) · 0.966
- Art. 89(1)(2) and Art. 84(1)(2) · 1.000
- Art. 89(2) and Art. 84(2) · 0.987
- Art. 89(2)(1) and Art. 84(2)(1) · 0.986
- Art. 89(3) and Art. 84(3) · 0.990
- Art. 89(3)(1) and Art. 84(3)(1) · 0.992
- Art. 89(3)(2) and Art. 84(3)(2) · 0.971
- Art. 89(4) and Art. 84(4) · 1.000
- Art. 89(4)(1) and Art. 84(4)(1) · 1.000
- Art. 89(5) and Art. 84(5) · 0.978
- Art. 89(5)(1) and Art. 84(5)(1) · 0.977
- Art. 89(7) and Art. 84(7) · 0.937
- Art. 89(7)(1) and Art. 84(7)(1) · 0.936
- Art. 89(8) and Art. 84(8) · 0.984
- Art. 89(8)(1) and Art. 84(8)(1) · 0.992
- Art. 89(8)(2) and Art. 84(8)(2) · 0.979
- Art. 89(8)(3) and Art. 84(8)(3) · 0.963
- Art. 89(9) and Art. 84(9) · 0.995
- Art. 89(9)(1) and Art. 84(9)(1) · 1.000
- Art. 89(9)(1)(a) and Art. 84(9)(1)(a) · 1.000
- Art. 89(9)(1)(b) and Art. 84(9)(1)(b) · 1.000
- Art. 89(9)(2) and Art. 84(9)(2) · 1.000
- Art. 89(9)(3) and Art. 84(9)(3) · 1.000
- Art. 89(9)(4) and Art. 84(9)(4) · 0.970
- Art. 89(10) and Art. 84(10) · 1.000
- Art. 89(10)(1) and Art. 84(10)(1) · 1.000
- Art. 89(11) and Art. 84(11) · 1.000
- Art. 89(11)(1) and Art. 84(11)(1) · 1.000
Changes since the texts were paired
The record holds no change to either provision after the versions they were paired on.