EMDT_European Medical Device Technology

European Medical Device Technology, Spring 2015

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emdt.co.uk European Medical Device Technology Spring 2015 | 17 becomes aware of the new reportable event or the new information related to an event already reported. Device deficiencies must be reported if they did not lead to an adverse event but could have led to a medical occurrence if: 0 Either a suitable action had not been taken 0 Intervention had not been made, or 0 Circumstances had been less fortunate German Reporting Requirements Sponsors of clinical studies conducted in Germany should be aware of the SAE reporting requirements in advance of the need for reporting. This is because the Federal Institute for Drugs and Medical Devices (BfArM), the German Competent Authority, has specific requirements for SAE reporting that will not be fulfilled if sponsors follow only the AIMD, MDD or European SAE guideline. Reporting requirements for SAEs also apply to reportable device deficiencies, as specified in EN ISO 14155:2011 and the European SAE guideline. The forms that must be used to report SAEs to BfArM and the timeline for reporting depend upon the presumed cause of the SAE (device / procedure related or not) and whether or not the SAE has occurred in Germany or outside Germany. The German SAE report form must be used when there may be a causal relation- ship between the SAE and the investi- gational medical device, a comparator device, a diagnostic or therapeutic pro- cedure performed as part of the clinical study, or other conditions of the study, and the event occurred in Germany. If the event occurred outside of Germany, the MEDDEV 2.7.3 reporting form—called a summary table on the BfArM Web site— must be used. On the other hand, when it is possible to exclude a causal relationship between the SAE and the investigational medical device, a comparator device, a diagnostic or therapeutic procedure performed as part of the clinical study, or other conditions of the study conduct, the MEDDEV reporting form must be used and the reports submitted quarterly. There are additional requirements that some companies find quite confusing, however, with regard to the MEDDEV report form, which is an Excel file. Regardless of causality, all SAEs that occur outside of Germany and the quarterly listings of SAEs that occur in Germany must be documented using the same Excel file, in a cumulative manner, using separate Excel sheets. That is, all SAEs that occurred outside of Germany must be documented on one sheet (sheet 1), irrespective of immediate or quarterly reports, whereas, quarterly listings of SAEs that occurred in Germany must be included on a separate sheet (sheet 2). T E C H N O L O G Y

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