Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 58 Paragraph 7 â 8: Difference between revisions
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{{:Document:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023}} | {{:Document:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023}} | ||
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! | ! colspan="2" class="gplx-infobox-header" | Reference Details | ||
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! Scope | |||
| IVD | | IVD | ||
|- | |- | ||
! | ! Document part | ||
| Article 58 | | Article 58 | ||
Paragraph 7 â 8 | Paragraph 7 â 8 | ||
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! | ! Language | ||
| EN | | EN | ||
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! | ! Original entry by | ||
| Florian Adragna | | Florian Adragna | ||
|- | |- | ||
! | ! Contributors | ||
| Â | | Â | ||
|- | |- | ||
! | ! Tags (EN) | ||
| Â | | Â | ||
|- | |- | ||
! | ! Tags (original language) | ||
| Â | | Â | ||
|- | |- | ||
! | ! Tags (FR) | ||
| Â | | Â | ||
|- | |- | ||
! | ! Comment | ||
| Investigator qualification: professional recognition requirements | | Investigator qualification: professional recognition requirements | ||
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== | == Content == | ||
7. The investigator shall be a person exercising a profession which is recognised in the Member State concerned, as qualifying for the role of investigator on account of having the necessary scientific knowledge and experience in patient care or laboratory medicine. Other personnel involved in conducting a performance study shall be suitably qualified, by education, training or experience in the relevant medical field and in clinical research methodology, to perform their tasks. | 7. The investigator shall be a person exercising a profession which is recognised in the Member State concerned, as qualifying for the role of investigator on account of having the necessary scientific knowledge and experience in patient care or laboratory medicine. Other personnel involved in conducting a performance study shall be suitably qualified, by education, training or experience in the relevant medical field and in clinical research methodology, to perform their tasks. | ||
8. Where appropriate, the facilities where the performance study involving subjects is to be conducted shall be suitable for the performance study and shall be similar to the facilities where the device is intended to be used. | 8. Where appropriate, the facilities where the performance study involving subjects is to be conducted shall be suitable for the performance study and shall be similar to the facilities where the device is intended to be used. | ||
Revision as of 14:27, 29 June 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 | |
|---|---|
| Scope | IVD |
| Document part | Article 58
Paragraph 7 â 8 |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags (EN) | |
| Tags (original language) | |
| Tags (FR) | |
| Comment | Investigator qualification: professional recognition requirements |
Content
7. The investigator shall be a person exercising a profession which is recognised in the Member State concerned, as qualifying for the role of investigator on account of having the necessary scientific knowledge and experience in patient care or laboratory medicine. Other personnel involved in conducting a performance study shall be suitably qualified, by education, training or experience in the relevant medical field and in clinical research methodology, to perform their tasks.
8. Where appropriate, the facilities where the performance study involving subjects is to be conducted shall be suitable for the performance study and shall be similar to the facilities where the device is intended to be used.
