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Document:EU ; GBR MDCG 2020-10/1 - Safety reporting in clinical investigations of medical devices 2020: Difference between revisions

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|DocReference=EU ; GBR  MDCG 2020-10/1
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Safety reporting in clinical investigations
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Safety reporting in clinical investigations
of medical devices
|DocVersion=2020
|DocStatus=Current
|DocType=Official recommendation
|DocLanguage=EN
|DocDescription=MDCG 2020-10/1 Rev 1
Safety reporting in clinical investigations of medical devices under the Regulation (EU) 2017/745
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|reference=EU ; GBR  MDCG 2020-10/1
|reference=EU ; GBR  MDCG 2020-10/1
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Line 43: Line 21:
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<noinclude>
== References ==
{| class="wikitable"
! Reference !! Scope !! Document part !! Language !! Preview
|-
| [[Reference:EU ; GBR MDCG 2020-10/1 - Safety reporting in clinical investigations of medical devices 2020 8.2-001]] || MD || 8.2 || EN || 8 Reporting timelines [...] 8.2 Report by the investigator to the sponsor The sponsor shall implement and maintain a system to ensure that the reporting of the reportable events as defined under ...
|-
| [[Reference:EU ; GBR MDCG 2020-10/1 - Safety reporting in clinical investigations of medical devices 2020 8.2-002]] || MD || 8.2 || EN || 8 Reporting timelines [...] 8.2 Report by the investigator to the sponsor The sponsor shall implement and maintain a system to ensure that the reporting of the reportable events as defined under ...
|-
| [[Reference:EU ; GBR MDCG 2020-10/1 - Safety reporting in clinical investigations of medical devices 2020 8-001]] || MD || 8 || EN || 8 Reporting timelines 8.1 Report by sponsor to NCAs. The sponsor must report to all NCAs where the clinical investigation is authorised to start: • For all reportable events as described in section 5 ...
|-
| [[Reference:EU ; GBR MDCG 2020-10/1 - Safety reporting in clinical investigations of medical devices 2020 8-002]] || MD || 8 || EN || 8 Reporting timelines 8.1 Report by sponsor to NCAs. The sponsor must report to all NCAs where the clinical investigation is authorised to start: • For all reportable events as described in section 5 ...
|}
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Latest revision as of 14:15, 16 July 2026


Document information
Reference EU ; GBR MDCG 2020-10/1

- Safety reporting in clinical investigations of medical devices 2020

Validity area EU ; GBR
Scope(s) MD
Document name MDCG 2020-10/1

- Safety reporting in clinical investigations of medical devices

Version / Revision 2020
Status Current
Document type Official recommendation
Language(s) EN
Description MDCG 2020-10/1 Rev 1

Safety reporting in clinical investigations of medical devices under the Regulation (EU) 2017/745

Official source Official link
Restricted access No
Submitted by Florian Adragna
Contributors

References

 ScopeDocument partLanguagePreview
EU ; GBR MDCG 2020-10/1 - Safety reporting in clinical investigations of medical devices 2020 8-001MD8EN8 Reporting timelines

8.1 Report by sponsor to NCAs. The sponsor must report to all NCAs where the clinical investigation is authorised to start:

• Fo…
EU ; GBR MDCG 2020-10/1 - Safety reporting in clinical investigations of medical devices 2020 8-002MD8EN8 Reporting timelines

8.1 Report by sponsor to NCAs. The sponsor must report to all NCAs where the clinical investigation is authorised to start:

• Fo…
EU ; GBR MDCG 2020-10/1 - Safety reporting in clinical investigations of medical devices 2020 8.2-001MD8.2EN8 Reporting timelines

[...] 8.2 Report by the investigator to the sponsor

The sponsor shall implement and maintain a system to ensure that the reporti…
EU ; GBR MDCG 2020-10/1 - Safety reporting in clinical investigations of medical devices 2020 8.2-002MD8.2EN8 Reporting timelines

[...] 8.2 Report by the investigator to the sponsor

The sponsor shall implement and maintain a system to ensure that the reporti…
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