# 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 C: Annual Notification Format for Serious Adverse Events

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

Reporting establishment
Reporting period
1 January-31 December (year)
Total number of blood and blood components processed:
Serious adverse event, affecting quality and safety of blood component due to a deviation in:
Total number
Specification
Product defect
Equipment failure
Human error
Other(specify)
Whole blood collection
Apheresis collection
Testing of donations
Processing
Storage
Distribution
Materials
Others (specify)

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