Reference:GBR MEDDEV 2.7/3 revision 3 May-2015 8

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
Module	Module 5 — Unit 5.1.3
Scope	MD
Document part	8
Language	EN
Original entry by	Florian Adragna
Contributors
Tags	Causality, Medical device, Adverse event, Unanticipated device effect
Comment	Causality assessment for device-related adverse events

Content

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. During causality assessment activity, clinical judgement shall be used and the relevant documents, such as the Investigator’s Brochure, the Clinical Protocol or the risk Analysis Report shall be consulted, as all the foreseeable serious adverse events and the potential risks are listed and assessed there. The presence of confounding factors, such as concomitant medication/treatment, the natural history of the underlying disease, other concurrent illness or risk factors shall also be considered. The above considerations apply also to the serious adverse events occurring in the comparison group. For the purpose of harmonising reports, each SAE will be classified according to five different levels of causality. The sponsor and the investigators will use the following definitions to assess the relationship of the serious adverse event to the investigational medical device or procedures.

1) Not related [...]

2) Unlikely: [...]

3) Possible [...]

4) Probable [...]

5) Causal relationship [...]

The sponsor and the investigators will distinguish between the serious adverse events related to the investigational device and those related to the procedures (any procedure specific to the clinical investigation). An adverse event can be related both to procedures and the investigational device. Complications of procedures are considered not related if the said procedures would have been applied to the patients also in the absence of investigational device use/application. In some particular cases the event may be not adequately assessed because information is insufficient or contradictory and/or the data cannot be verified or supplemented. The sponsor and the Investigators will make the maximum effort to define and categorize the event and avoid these situations. Where the sponsor remains uncertain about classifying the serious event, it should not exclude the relatedness and classify the event as “possible”. Particular attention shall be given to the causality evaluation of unanticipated serious adverse (device) events. The occurrence of unanticipated events related to the use of the device (USADE) could suggest that the clinical investigation places subjects at increased risk of harm than was to be expected beforehand.