Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 05-May-2017 Preamble Preamble: Difference between revisions
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| | |has_document=Document:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 05-May-2017 Preamble | ||
| | |module=1 | ||
| | |unit=1.3.0 | ||
| | |scope=IVD | ||
| | |doc_part=Preamble | ||
| | |language=EN | ||
| | |entry_by=Florian Adragna | ||
|contributors= | |||
ย | |tags=TAG-00231-Per-ung ++ TAG-00043-Goo-tek ++ TAG-00218-Har-pรคi ++ TAG-00220-Inv-agn | ||
|tags_display=[[Glossary:TAG-00231-Per-ung|Performance study]], [[Glossary:TAG-00043-Goo-tek|Good clinical practice]], [[Glossary:TAG-00218-Har-pรคi|Harmonised standard]], [[Glossary:TAG-00220-Inv-agn|IVD]] | |||
ย | |comment=Performance study rules aligned with international standards | ||
|content=EU Regulation 2017/746 โ Preamble: | |||
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EU Regulation 2017/746 โ 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 [โฆ] | (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 [โฆ] | ||
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. | ||
}} | |||
Latest revision as of 13:49, 16 July 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 | |
|---|---|
| Module | Module 1 โ 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 โ 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 [โฆ]
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.
