| European Union regulation | |
 | |
| Title | Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (Text with EEA relevance) |
|---|---|
| Made by | Council |
| Made under | TFEU/art 294 par 6 |
| Journal reference | L117, 5 May 2017 pp. 1–175 |
| History | |
| Date made | 5 April 2017 |
| Entry into force | 25 May 2017 |
| Implementation date | (new date) 26 May 2021 |
| Other legislation | |
| Replaces | Directive 90/385/EEC, Directive 93/42/EEC |
| Amends | Directive 2001/83/EC, Regulation (EC) No 178/2002, and Regulation (EC) No 1223/2009 |
| Current legislation | |
Regulation (EU) 2017/745 is a regulation of the European Union on the clinical investigation and sale of medical devices for human use. It repealed Directive 93/42/EEC on Medical Devices (MDD), and Directive 90/385/EEC, which concerns active implantable medical device.
The regulation was published on 5 April 2017 and came into force on 25 May 2017.[1][2][3] Originally approved medical devices will have a transition time of three years[4][5] (until 26 May 2021) to meet new requirements.
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- ^ "EU Medical Device Regulation". tuv-sud.com. Archived from the original on 24 May 2018. Retrieved 12 April 2018.
- ^ "New Medical Devices Regulation and IVD Regulation text published – BSI Group". bsigroup.com. Archived from the original on 12 July 2024. Retrieved 12 April 2018.