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Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 77 Paragraph 6 – 7: Difference between revisions

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|has_document=Document:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023
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ParagraphΒ  6 – 7
ParagraphΒ  6 – 7
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|tags_display=[[Glossary:TAG-00050-Cli-ber|Clinical study report]], [[Glossary:TAG-00275-Lay-ndl|Lay summary]], [[Glossary:TAG-00017-Spo-die|Sponsor]], [[Glossary:TAG-00201-Cli-eSt|Clinical investigation]]
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|comment=Commission guidelines on summary content and structure
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|content=6.Β  The Commission shall issue guidelines regarding the content and structure of the summary of the clinical investigation report.
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! colspan="2" class="gplx-infobox-header" | Reference Details
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! Document part
| Article 77
ParagraphΒ  6 – 7
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| EN
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! Original entry by
| Florian Adragna
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== Content ==
6.Β  The Commission shall issue guidelines regarding the content and structure of the summary of the clinical investigation report.


In addition, the Commission may issue guidelines for the formatting and sharing of raw data, for cases where the sponsor decides to share raw data on a voluntary basis. Those guidelines may take as a basis and adapt, where possible, existing guidelines for sharing of raw data in the field of clinical investigations.
In addition, the Commission may issue guidelines for the formatting and sharing of raw data, for cases where the sponsor decides to share raw data on a voluntary basis. Those guidelines may take as a basis and adapt, where possible, existing guidelines for sharing of raw data in the field of clinical investigations.
Line 53: Line 19:


If the device is not registered in accordance with Article 29 within one year of the summary and the report having been entered into the electronic system pursuant to paragraph 5 of this Article, they shall become publicly accessible at that point in time.
If the device is not registered in accordance with Article 29 within one year of the summary and the report having been entered into the electronic system pursuant to paragraph 5 of this Article, they shall become publicly accessible at that point in time.
}}

Latest revision as of 13:50, 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 6 β€” Unit 6.4.2
Scope MD
Document part Article 77

Paragraph 6 – 7

Language EN
Original entry by Florian Adragna
Contributors
Tags Clinical study report, Lay summary, Sponsor, Clinical investigation

Content

6. The Commission shall issue guidelines regarding the content and structure of the summary of the clinical investigation report.

In addition, the Commission may issue guidelines for the formatting and sharing of raw data, for cases where the sponsor decides to share raw data on a voluntary basis. Those guidelines may take as a basis and adapt, where possible, existing guidelines for sharing of raw data in the field of clinical investigations.

7. The summary and the clinical investigation report referred to in paragraph 5 of this Article shall become publicly accessible through the electronic system referred to in Article 73, at the latest when the device is registered in accordance with Article 29 and before it is placed on the market. In cases of early termination or temporary halt, the summary and the report shall become publicly accessible immediately after submission.

If the device is not registered in accordance with Article 29 within one year of the summary and the report having been entered into the electronic system pursuant to paragraph 5 of this Article, they shall become publicly accessible at that point in time.

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