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The Commission of the European Union (EU), the sole EU body capable of proposing new legislation, has updated the list of harmonized standards used in the process of accrediting laboratories involved in the development or assessment of medical devices.

Specifically, Commission Implementing Decision (EU) 2024/581 replaces EN ISO 15189:2012, Medical laboratories: Requirements for quality and competence, with the more updated version of the standard, EN ISO 15189:2022, as amended, on its list of harmonized standards applicable under Regulation (EC) No 765/2008.

The Commission’s Implementing Decision on EN ISO 15189 was published in mid-February in the Official Journal of the European Union and entered into force as of February 16.

Click here to learn more about EU's Commission Implementing Decision.