# Commission Directive 2005/61/EC of 30 September 2005 implementing Directive 2002/98/EC of the European Parliament and of the Council as regards traceability requirements and notification of serious adverse reactions and events (Text with EEA relevance), Part B

Extent: E+W+S+N.I.

Serious adverse reactions — imputability levels
Imputability levels to assess serious adverse reactions.
Imputability level
Explanation
NA
Not assessable
When there is insufficient data for imputability assessment.
0
Excluded
When there is conclusive evidence beyond reasonable doubt for attributing the adverse reaction to alternative causes.
Unlikely
When the evidence is clearly in favour of attributing the adverse reaction to causes other than the blood or blood components.
1
Possible
When the evidence is indeterminate for attributing adverse reaction either to the blood or blood component or to alternative causes.
2
Likely, Probable
When the evidence is clearly in favour of attributing the adverse reaction to the blood or blood component.
3
Certain
When there is conclusive evidence beyond reasonable doubt for attributing the adverse reaction to the blood or blood component.

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Source: https://www.legislation.gov.uk/eudr/2005/61/annex/II/part/B (the official version)
Page: https://openlegislation.uk/eu-directive-2005-61/annex-II/part-B
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.