More resources for the Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (Text with EEA relevance)
Original Print PDF of EU Official Journal Version
This PDF does not include any changes made by corrigenda.![]()
Original Print PDF
This is the PDF of the original version as first adopted in the EU that was published in the EU official journal. It therefore does not include any changes made by corrigendum (correction slips) issued after it was published. Corrigendum if issued will be listed separately under 'More Resources' and will have been applied to the HTML version viewable via the content tab.
- Download - English1.41MB
Associated Documents
- Revised Version 5/5/2017 1.42MB
- Corrigendum - 03/05/2019 481kB
- Corrigendum - 27/12/2019 562kB
In Force Information
This data is taken from the Document Information page on EUR-Lex. Some of the terminology may differ from that used for UK legislation.
| Date of document | 05/04/2017 | ||
|---|---|---|---|
| Date of effect | N/A | Application | Partial application See Art 113.3(f) |
| Date of effect | 25/05/2017 | Entry into force | Date pub. +20 See Art 113.1 |
| Date of effect | 26/11/2017 | Application | Partial application See Art 113.3(b) |
| Date of effect | 26/05/2018 | Application | Partial application See Art 113.3(c) |
| Date of effect | 26/05/2019 | Application | Partial application See Art 113.3(h) |
| Date of effect | 25/11/2020 | Application | Partial application See Art 113.3(d) |
| Date of effect | 26/05/2022 | Application | See Art 113.2 |
| Date of effect | 26/05/2022 | Application | Partial application See Art 113.3(b) |
| Date of effect | 26/05/2023 | Application | Partial application See Art 113.3(e) |
| Date of effect | 27/11/2023 | Application | Partial application See Art 113.3(a) |
| Date of effect | 26/05/2025 | Application | Partial application See Art 113.3(e) |
| Date of effect | 26/05/2027 | Application | Partial application See Art 113.3(e) And 113.3(g) |
List of all changes :
- Affecting the Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (Text with EEA relevance)
- Made by the Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (Text with EEA relevance) affecting other Legislation
