# Commission Decision of 7 May 2002 on common technical specifications for in vitro-diagnostic medical devices (notified under document number C(2002) 1344) (Text with EEA relevance) (2002/364/EC), Division 3.1.12

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

Devices shall have a specificity of at least 99,5 % on blood donations, unless otherwise indicated in the accompanying tables. Specificity shall be calculated using the frequency of repeatedly reactive (i.e. false positive) results in blood donors negative for the target marker.

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Source: https://www.legislation.gov.uk/eudn/2002/364/annex/division/3/division/3.1/division/1/division/3.1.12 (the official version)
Page: https://openlegislation.uk/eu-decision-2002-364/annex/division-3/division-3.1/division-1/division-3.1.12
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.