# Commission Directive 2006/86/EC of 24 October 2006 implementing Directive 2004/23/EC of the European Parliament and of the Council as regards traceability requirements, notification of serious adverse reactions and events and certain technical requirements for the coding, processing, preservation, storage and distribution of human tissues and cells (Text with EEA relevance), Division PART A: Rapid notification for suspected serious adverse events

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

Tissue establishment
EU tissue establishment code (if applicable)
Report identification
Reporting date (year/month/day)
Date of serious adverse event (year/month/day)
Serious adverse event, which may affect quality and safety of tissues and cells due to a deviation in:
Specification
Tissues and cells defect
Equipment failure
Human error
Other (specify)
Procurement
Testing
Transport
Processing
Storage
Distribution
Materials
Others (specify)

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Source: https://www.legislation.gov.uk/eudr/2006/86/annex/IV/part/A (the official version)
Page: https://openlegislation.uk/eu-directive-2006-86/annex-IV/part-A
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.