1.

The competent authority of a Member State shall designate only laboratories for diagnostic services pursuant to Article 57 that fulfil the following requirements. They must: undertake to notify, without delay, the competent authority whenever a laboratory is aware of a suspicion of any of the diseases referred to in Annex IV; undertake to participate in comparative tests (ring-tests) of diagnostic procedures arranged by the national reference laboratory; operate and be assessed and accredited in accordance with the following European Standards account being taken of the criteria for different testing methods laid down in this Directive: EN ISO/IEC 17025 on ‘General requirements for the competence of testing and calibration laboratories’; EN 45002 on ‘General criteria for the assessment of testing laboratories’; EN 45003 on ‘Calibration and testing laboratory accreditation system — General requirements for operation and recognition’.

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Source: EUR-Lex (Cellar) · retrieved 2026-11-02 · Text as adopted (Official Journal); later amendments are not incorporated in this text.