Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 59 Paragraph 2: Difference between revisions
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| | | [[Glossary:TAG-00031-Pat-onA|Patient information sheet]], [[Glossary:TAG-00029-Inf-rte|Informed consent]], [[Glossary:TAG-00028-Leg-ich|Legal representative]], [[Glossary:TAG-00231-Per-ung|Performance study]] | ||
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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 3 — Unit 3.1.1 |
| Scope | IVD |
| Document part | Article 59
Paragraph 2 |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Patient information sheet, Informed consent, Legal representative, Performance study |
| Comment | Information to be provided to subject in performance study |
Content
2. Information given to the subject or, where the subject is not able to give informed consent, his or her legally designated representative for the purposes of obtaining his or her informed consent shall:
(a) enable the subject or his or her legally designated representative to understand:
(i) the nature, objectives, benefits, implications, risks and inconveniences of the performance study;
(ii) the subject's rights and guarantees regarding his or her protection, in particular his or her right to refuse to participate in and the right to withdraw from the performance study at any time without any resulting detriment and without having to provide any justification;
(iii) the conditions under which the performance study is to be conducted, including the expected duration of the subject's participation in the performance study; and
(iv) the possible treatment alternatives, including the follow-up measures if the participation of the subject in the performance study is discontinued;
(b) be kept comprehensive, concise, clear, relevant, and understandable to the subject or his or her legally designated representative;
(c) be provided in a prior interview with a member of the investigating team who is appropriately qualified under national law; and
(d) include information about the applicable damage compensation system referred to in Article 65;
(e) include the Union-wide unique single identification number for the performance study referred to in Article 66(1) and information about the availability of the performance study results in accordance with paragraph 6 of this Article.
