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Document:GBR MEDDEV 2.7/3 revision 3 May-2015: Difference between revisions

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|DocLanguage=EN
|DocDescription=GUIDELINES ON MEDICAL DEVICES CLINICAL INVESTIGATIONS:
SERIOUS ADVERSE EVENT REPORTING UNDER DIRECTIVES 90/385/EEC AND 93/42/EEC.
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|DocSubmittedBy=Florian Adragna
|DocContributors=
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|reference=GBRΒ  MEDDEV 2.7/3 revision 3Β  May-2015
|validity_area=GBR
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<noinclude>
== References ==
{| class="wikitable" style="width:100%;"
! Reference !! Scope !! Document part !! Language !! Preview
|-
| [[Reference:GBR MEDDEV 2.7/3 revision 3 May-2015 8]] || MD || 8 || EN || 8. CAUSALITY ASSESSMENT The relationship between the use of the medical device (including the medical - surgical procedure) and the occurrence of each adverse event shall be assessed and categorized. ...
|-
| [[Reference:GBR MEDDEV 2.7/3 revision 3 May-2015 7.2]] || MD || 7.2 || EN || 7. REPORTING TIMELINES [...] 7.2 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:GBR MEDDEV 2.7/3 revision 3 May-2015 4]] || MD || 4 || EN || CLINICAL INVESTIGATIONS: SERIOUS ADVERSE EVENT REPORTING UNDER DIRECTIVES 90/385/EEC AND 93/42/EEC 4. REPORTABLE EVENTS UNDER ANNEX 7 AND ANNEX X OF DIRECTIVES 90/385/EEC AND 93/42/EEC RESPECTIVELY ...
|-
| [[Reference:GBR MEDDEV 2.7/3 revision 3 May-2015 5 - 6]] || MD || 5 - 6 || EN || CLINICAL INVESTIGATIONS: SERIOUS ADVERSE EVENT REPORTING UNDER DIRECTIVES 90/385/EEC AND 93/42/EEC 5. REPORT BY WHOM. Reportable events have to be reported by the sponsor of the clinical ...
|-
| [[Reference:GBR MEDDEV 2.7/3 revision 3 May-2015 7.1]] || MD || 7.1 || EN || 7. REPORTING TIMELINES 7.1 Report by sponsor to NCAs. The sponsor must report to the NCAs where the clinical investigation has commenced: - for all reportable events as described in section 4 which ...
|}
</noinclude>

Latest revision as of 14:15, 16 July 2026


Document information
Reference GBR MEDDEV 2.7/3 revision 3 May-2015
Validity area GBR
Scope(s) MD
Document name MEDDEV 2.7/3 revision 3
Version / Revision May-2015
Status Current
Document type Official guideline
Language(s) EN
Description GUIDELINES ON MEDICAL DEVICES CLINICAL INVESTIGATIONS:

SERIOUS ADVERSE EVENT REPORTING UNDER DIRECTIVES 90/385/EEC AND 93/42/EEC.

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

References

 ScopeDocument partLanguagePreview
GBR MEDDEV 2.7/3 revision 3 May-2015 4MD4ENCLINICAL INVESTIGATIONS: SERIOUS ADVERSE EVENT REPORTING UNDER DIRECTIVES 90/385/EEC AND 93/42/EEC 4. REPORTABLE EVENTS UNDER ANNEX 7 AND ANNEX X OF …
GBR MEDDEV 2.7/3 revision 3 May-2015 5 - 6MD5 - 6ENCLINICAL INVESTIGATIONS: SERIOUS ADVERSE EVENT REPORTING UNDER DIRECTIVES 90/385/EEC AND 93/42/EEC

5. REPORT BY WHOM.

Reportable events have to be re…
GBR MEDDEV 2.7/3 revision 3 May-2015 7.1MD7.1EN7. REPORTING TIMELINES

7.1 Report by sponsor to NCAs. The sponsor must report to the NCAs where the clinical investigation has commenced:

- for all re…
GBR MEDDEV 2.7/3 revision 3 May-2015 7.2MD7.2EN7. REPORTING TIMELINES

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

The sponsor shall implement and maintain a system to ensure that the report…
GBR MEDDEV 2.7/3 revision 3 May-2015 8MD8EN8. CAUSALITY ASSESSMENT The relationship between the use of the medical device (including the medical - surgical procedure) and the occurrence of each…
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