Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 63 Paragraph 2: Difference between revisions
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{{ | {{ReferenceData | ||
| | |has_document=Document:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 | ||
| | |module=3 | ||
| | |unit=3.1.1 | ||
|scope=MD | |||
|doc_part=Article 63 | |||
Paragraph 2 | Paragraph 2 | ||
| | |language=EN | ||
| | |entry_by=Florian Adragna | ||
| | |contributors= | ||
| | |tags=TAG-00031-Pat-onA ++ TAG-00029-Inf-rte ++ TAG-00028-Leg-ich ++ TAG-00201-Cli-eSt ++ TAG-00155-Med-Med | ||
|tags_display=[[Glossary:TAG-00031-Pat-onA|Patient information sheet]], [[Glossary:TAG-00029-Inf-rte|Informed consent]], [[Glossary:TAG-00028-Leg-ich|Legal representative]], [[Glossary:TAG-00201-Cli-eSt|Clinical investigation]], [[Glossary:TAG-00155-Med-Med|Medical device]] | |||
|comment=Information to be provided to subject in device investigation | |||
|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: | |||
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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: | (a) enable the subject or his or her legally designated representative to understand: | ||
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(e) include the Union-wide unique single identification number of the clinical investigation referred to in Article 70(1) and information about the availability of the clinical investigation results in accordance with paragraph 6 of this Article. | (e) include the Union-wide unique single identification number of the clinical investigation referred to in Article 70(1) and information about the availability of the clinical investigation results in accordance with paragraph 6 of this Article. | ||
}} | |||
Latest revision as of 13:49, 16 July 2026
| Document information | |
|---|---|
| Reference | EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 |
| Validity area | EU |
| Scope(s) | MD |
| Document name | Regulation (EU) 2017/745 - Medical Device Regulation |
| Version / Revision | 20-Mar-2023 |
| Status | Current |
| Document type | Legal act |
| Language(s) | EN |
| Description | REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC |
| Official source | Official link |
| Restricted access | No |
| Submitted by | Florian Adragna |
| Contributors | |
| Reference Details | |
|---|---|
| Module | Module 3 — Unit 3.1.1 |
| Scope | MD |
| Document part | Article 63
Paragraph 2 |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Patient information sheet, Informed consent, Legal representative, Clinical investigation, Medical device |
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 clinical investigations;
(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 clinical investigation at any time without any resulting detriment and without having to provide any justification;
(iii) the conditions under which the clinical investigations is to be conducted, including the expected duration of the subject's participation in the clinical investigation; and
(iv) the possible treatment alternatives, including the follow-up measures if the participation of the subject in the clinical investigation 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;
(d) include information about the applicable damage compensation system referred to in Article 69; and
(e) include the Union-wide unique single identification number of the clinical investigation referred to in Article 70(1) and information about the availability of the clinical investigation results in accordance with paragraph 6 of this Article.
