Reference:GBR MEDDEV 2.7/3 revision 3 May-2015 7.2

Document Information

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

Reference Details

Scope	MD
Document part	7.2
Language	EN
Original entry by	Florian Adragna
Contributors
Tags (EN)
Tags (original language)
Tags (FR)
Comment	Report timelines from investigator to sponsor

Text

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 chapter 4 will be provided by the investigator to the sponsor immediately, but not later than 3 calendar days after investigational site study personnel’s awareness of the event. In some cases, a different periodicity or different modalities 12 may be agreed by the participating NCAs according to the investigational design and to the pathology under clinical investigation. This would allow adequate provision for clinical investigations (e.g. palliative oncology), in which SAE frequency is expected to be high due to progression of the disease. This needs to be agreed between the sponsor and relevant NCAs.