Textual twins
Medical Devices Regulation Art. 46 and IVDR Art. 42 where the texts differ
textually similar (0.983) · 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. 46 and IVDR Art. 42 are textually similar: their words match at a ratio of 0.983, 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. 46 on EUR-Lex (external, EUR-Lex) · IVDR Art. 42 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. 46 | IVDR Art. 42 |
|---|---|---|
| 1 | Article 46 Changes to designations and notifications 1. | Article 42 Changes to designations and notifications 1. |
| 2 | body. The procedures described in Article 39 and in Article 42 shall apply | body. The procedures described in Article 35 and in Article 38 shall apply |
| 3 | in Article 39 and in Article 42 shall apply to extensions of the | in Article 35 and in Article 38 shall apply to extensions of the |
| 4 | electronic system referred to in Article 57. 3. Where a notified body decides | electronic system referred to in Article 52. 3. Where a notified body decides |
| 5 | for market surveillance at their request. 7. In the event of restriction, suspension | for market surveillance at their request. 7 In the event of restriction, suspension |
| 6 | devices on the market; (d) enter into the electronic system referred to in | devices on the market; (d) enter in the electronic system referred to in |
| 7 | electronic system referred to in Article 57 information in relation to certificates of | electronic system referred to in Article 52 information in relation to certificates of |
| 8 | (e) inform the competent authority for medical devices of the Member State | (e) inform the competent authority for in vitro diagnostic medical devices of the Member State |
| 9 | electronic system referred to in Article 57 of the certificates for which it | electronic system referred to in Article 52 of the certificates for which it |
| 10 | certificates affected by the suspension or restriction, and the authority responsible for notified | certificates affected by the suspension or restriction and the authority responsible for notified |
| 11 | has the capability of continuing to monitor and remain responsible for existing certificates | has the capability of continuing to monitor, and remain responsible for, existing certificates |
| 12 | continuing to monitor and remain responsible for existing certificates issued for the period | continuing to monitor, and remain responsible for, existing certificates issued for the period |
5 more passages not shown; read both on EUR-Lex.
Aligned sub-provisions
Medical Devices Regulation first, then IVDR, each with its word ratio.
- Art. 46(1) and Art. 42(1) · 0.971
- Art. 46(1)(1) and Art. 42(1)(1) · 1.000
- Art. 46(1)(2) and Art. 42(1)(2) · 0.900
- Art. 46(1)(3) and Art. 42(1)(3) · 1.000
- Art. 46(2) and Art. 42(2) · 0.972
- Art. 46(2)(1) and Art. 42(2)(1) · 0.971
- Art. 46(3) and Art. 42(3) · 1.000
- Art. 46(3)(1) and Art. 42(3)(1) · 1.000
- Art. 46(4) and Art. 42(4) · 1.000
- Art. 46(4)(1) and Art. 42(4)(1) · 1.000
- Art. 46(4)(2) and Art. 42(4)(2) · 1.000
- Art. 46(5) and Art. 42(5) · 1.000
- Art. 46(5)(1) and Art. 42(5)(1) · 1.000
- Art. 46(6) and Art. 42(6) · 1.000
- Art. 46(6)(1) and Art. 42(6)(1) · 1.000
- Art. 46(7) and Art. 42(7) · 0.970
- Art. 46(7)(1) and Art. 42(7)(1) · 0.975
- Art. 46(7)(1)(a) and Art. 42(7)(1)(a) · 1.000
- Art. 46(7)(1)(b) and Art. 42(7)(1)(b) · 1.000
- Art. 46(7)(1)(c) and Art. 42(7)(1)(c) · 1.000
- Art. 46(7)(1)(d) and Art. 42(7)(1)(d) · 0.920
- Art. 46(7)(1)(e) and Art. 42(7)(1)(e) · 0.964
- Art. 46(8) and Art. 42(8) · 0.981
- Art. 46(8)(1) and Art. 42(8)(1) · 0.981
- Art. 46(8)(1)(a) and Art. 42(8)(1)(a) · 0.981
- Art. 46(8)(1)(b) and Art. 42(8)(1)(b) · 0.978
- Art. 46(9) and Art. 42(9) · 0.980
- Art. 46(9)(1) and Art. 42(9)(1) · 0.986
- Art. 46(9)(1)(a) and Art. 42(9)(1)(a) · 0.967
- Art. 46(9)(1)(b) and Art. 42(9)(1)(b) · 1.000
- Art. 46(9)(2) and Art. 42(9)(2) · 0.957
- Art. 46(9)(3) and Art. 42(9)(3) · 1.000
Changes since the texts were paired
The record holds no change to either provision after the versions they were paired on.