Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 05-May-2017 Preamble Preamble: Difference between revisions
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{{:Document:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 05-May-2017 Preamble}} | {{:Document:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 05-May-2017 Preamble}} | ||
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! | ! colspan="2" class="gplx-infobox-header" | Reference Details | ||
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! Scope | |||
| IVD | | IVD | ||
|- | |- | ||
! | ! Document part | ||
| Preamble | | Preamble | ||
|- | |- | ||
! | ! Language | ||
| EN | | EN | ||
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! | ! Original entry by | ||
| Florian Adragna | | Florian Adragna | ||
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! | ! Contributors | ||
| | | | ||
|- | |- | ||
! | ! Tags (EN) | ||
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! | ! Tags (original language) | ||
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! | ! Tags (FR) | ||
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! | ! Comment | ||
| Performance study rules aligned with international standards | | Performance study rules aligned with international standards | ||
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== | == Content == | ||
EU Regulation 2017/746 – Preamble: | EU Regulation 2017/746 – 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 […] | (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 […] | ||
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. | 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. | ||
Revision as of 14:27, 29 June 2026
| 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 | |
|---|---|
| Scope | IVD |
| Document part | Preamble |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags (EN) | |
| Tags (original language) | |
| Tags (FR) | |
| Comment | Performance study rules aligned with international standards |
Content
EU Regulation 2017/746 – 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 […]
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.
