#32026D0375Commission Implementing Decision (EU) 2026/375 on harmonised standards for accreditation under Regulation (EC) No 765/2008
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This Commission Implementing Decision publishes the reference of the harmonised standard EN ISO 20387:2020/A11:2024 (Biotechnology – Biobanking – General requirements for biobanking) in the Official Journal of the European Union. The standard was developed following a 2021 standardisation request to CEN in support of Regulation (EC) No 765/2008 on accreditation requirements. An earlier version lacked the required Annex Z, preventing publication; the 2024 amendment added it. Conformity with this standard gives a presumption of conformity for national accreditation bodies when assessing biobanking conformity assessment bodies under Article 8(10) of the Regulation. The decision entered into force on the day of its publication on 23 February 2026.
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Key Changes
- Publication of EN ISO 20387:2020 as amended by EN ISO 20387:2020/A11:2024 in the Official Journal
- Addition of Annex Z to the original 2020 standard enabling official recognition
- Presumption of conformity granted for national accreditation bodies under Article 8(10) of Regulation (EC) No 765/2008
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Obligations
What this law requires
National Accreditation Bodies must assess biobanking conformity assessment bodies against the harmonised standard EN ISO 20387:2020/A11:2024 when fulfilling obligations under Article 8(10) of Regulation (EC) No 765/2008
Biobanking conformity assessment bodies seeking accreditation must demonstrate conformity with EN ISO 20387:2020/A11:2024 (Biotechnology – Biobanking – General requirements for biobanking) to obtain presumption of conformity with accreditation requirements
Apply the harmonised standard EN ISO 20387:2020/A11:2024 as the reference standard for accreditation purposes in the biobanking sector from the date of publication (23 February 2026) onwards
Recognise conformity with EN ISO 20387:2020/A11:2024 as creating a presumption of conformity with accreditation requirements under Regulation (EC) No 765/2008 from the publication date