Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 05-May-2017 Preamble Preamble
From GxPlex
| Document information | |
|---|---|
| Reference | EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 05-May-2017 Preamble |
| Validity area | EU |
| Scope(s) | IVD |
| Document name | Regulation (EU) 2017/746 - in vitro diagnostic medical devices |
| Version / Revision | 05-May-2017 Preamble |
| Status | N.A. |
| Document type | Preamble of legal act |
| Language(s) | EN |
| Description | Preamble Regulation (EU) 2017/746 (for information) |
| Official source | Official link |
| Restricted access | No |
| Submitted by | Florian Adragna |
| Contributors | |
| Reference Details | |
|---|---|
| Module | Module 1 â Unit 1.3.0 |
| Scope | IVD |
| Document part | Preamble |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Performance study, Good clinical practice, Harmonised standard, IVD |
Content
EU Regulation 2017/746 â Preamble: (66) The rules on performance studies should be in line with well-established international guidance in this field, such as the international standard ISO 20916 on good clinical practice for clinical investigations of medical devices for human subjects [âŚ]
In addition, the rules should be in line with the most recent version of the World Medical Association Declaration of Helsinki on Ethical Principles for Medical Research Involving Human Subjects.
