# 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 3.5.1

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

All performance evaluations shall be carried out in direct comparison with an established state-of-the-art device. The device used for comparison shall be one bearing CE marking, if on the market at the time of the performance evaluation.

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Source: https://www.legislation.gov.uk/eudn/2002/364/annex/division/3/division/3.5/division/3.5.1 (the official version)
Page: https://openlegislation.uk/eu-decision-2002-364/annex/division-3/division-3.5/division-3.5.1
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.