Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 2 Paragraph 58: Difference between revisions
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| | | [[Glossary:TAG-00029-Inf-rte|Informed consent]], [[Glossary:TAG-00244-Def-ini|Definition]], [[Glossary:TAG-00231-Per-ung|Performance study]], [[Glossary:TAG-00026-Min-isc|Minor / Paediatric]], [[Glossary:TAG-00027-Inc-son|Incapacitated subject]], [[Glossary:TAG-00028-Leg-ich|Legal representative]] | ||
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Revision as of 17:29, 15 July 2026
| Document information | |
|---|---|
| Reference | EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 |
| Validity area | EU |
| Scope(s) | IVD |
| Document name | Regulation (EU) 2017/746 - in vitro diagnostic medical devices |
| Version / Revision | 20-Mar-2023 |
| Status | Current |
| Document type | Legal act |
| Language(s) | EN |
| Description | 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 |
| Official source | Official link |
| Restricted access | No |
| Submitted by | Florian Adragna |
| Contributors | |
| Reference Details | |
|---|---|
| Module | Module 1 — Unit 1.2.2 |
| Scope | IVD |
| Document part | Article 2
Paragraph 58 |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Informed consent, Definition, Performance study, Minor / Paediatric, Incapacitated subject, Legal representative |
| Comment | Definition of informed consent (IVD/performance study context) |
Content
Definitions
(58) ‘informed consent’ means a subject's free and voluntary expression of his or her willingness to participate in a particular performance study, after having been informed of all aspects of the performance study that are relevant to the subject's decision to participate or, in the case of minors and of incapacitated subjects, an authorisation or agreement from their legally designated representative to include them in the performance study;
