Commission Implementing Decision (EU) 2024/581 of 16 February 2024 on the harmonised standard for accreditation of medical laboratories drafted in support of Regulation (EC) No 765/2008 of the European Parliament and of the Council

Implementing Decision (EU) 2024/581 · Decision · 3 articles

Data as of 2026-07-04 · Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗

Article 1

The reference of harmonised standard EN ISO 15189:2022 as amended by EN ISO 15189:2022/A11:2023 Medical laboratories – Requirements for quality and competence (ISO 15189:2022) drafted in support of Regulation (EC) No 765/2008 is hereby published in the Official Journal of the European Union.

Article 2

The reference of the harmonised standard EN ISO 15189:2012 Medical laboratories – Requirements for quality and competence (ISO 15189:2012, Corrected version 2014-08-15) is hereby withdrawn from the Official Journal of the European Union , as from 20 August 2025.

Article 3

This Decision shall enter into force on the day of its publication in the Official Journal of the European Union.

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Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.

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