| Home | Journal | Directories | Resources | MAGI              | About Us | Contact Us | Sign In | Sign Up  
|<  <<  <  Page 5 of 6  >  >>  >|    Search Page    Contents Page

EC Guideline – Serious Adverse Event Reporting for Medical Devices

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 will be provided by the investigator to the sponsor in acceptable timely conditions, but not later than within 3 calendar days after the occurrence 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.

[12] in line with Annex 7.2.3.5 of Directive 90/385/EEC and Annex X.2.3.5 of Directive 93/42/EEC

8. REPORTING FORM

The reporting form template for the summary SAE tabulation is given in the Appendix of this document.

The table gives a cumulative overview of the reportable events per clinical investigation and will be updated and transmitted to participating NCAs each time a new reportable event or a new finding to an already reported event is to be reported. More detailed information has to be provided on request of an NCA.

The sponsor shall identify the new/updated information in the status column of the tabular form featured in the Appendix as:
a = added = new reportable event;

m = modified = new finding/update to an already reported event;

u = unchanged.
Changes in a line should be highlighted in bold and/or color in the respective column.

The reporting form is study specific and covers only a given clinical investigation, defined by a distinct clinical investigation plan. English is the recommended language for the reporting form. The report should be sent by email preferably in Excel or equivalent format to the participating NCAs.

REFERENCES:

1. Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices, last amended by Directive 2007/47/EC.

2. Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, last amended by Directive 2007/47/EC.

3. ISO/FDIS 14155:2010 Clinical investigation of medical devices for human subjects – Good clinical practice

APPENDIX – REPORTING FORM

MEDDEV 2.7/3 SAE Report Table- V1





|<  <<  <  Page 5 of 6  >  >>  >|    Search Page    Contents Page
© 2003-2012 First Clinical Research LLC.  Trademark Notice  Terms & Conditions  Privacy Statement  Site Map