Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 63 Paragraph 3 â 5: Difference between revisions
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| Â | | [[Glossary:TAG-00031-Pat-onA|Patient information sheet]], [[Glossary:TAG-00029-Inf-rte|Informed consent]], [[Glossary:TAG-00028-Leg-ich|Legal representative]], [[Glossary:TAG-00155-Med-Med|Medical device]] | ||
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Revision as of 17:29, 15 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 â Unit 3.1.1 |
| Scope | MD |
| Document part | Article 63
Paragraph 3 â 5 |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Patient information sheet, Informed consent, Legal representative, Medical device |
| Comment | Written format requirement for subject information (device) |
Content
3. The information referred to in paragraph 2 shall be prepared in writing and be available to the subject or, where the subject is not able to give informed consent, his or her legally designated representative.
4. In the interview referred to in point (c) of paragraph 2, special attention shall be paid to the information needs of specific patient populations and of individual subjects, as well as to the methods used to give the information.
5. In the interview referred to in point (c) of paragraph 2, it shall be verified that the subject has understood the information.
