Article 1
The Annex to Implementing Decision (EU) 2021/1195 is amended in accordance with the Annex to this Decision.
Commission Implementing Decision (EU) 2022/15 of 6 January 2022 amending Implementing Decision (EU) 2021/1195 as regards harmonised standards for sterilisation of health care products, aseptic processing of health care products, quality management systems, symbols to be used with information to be supplied by the manufacturer and requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples
Commission Implementing Decision (EU) 2022/15 of 6 January 2022 amending Implementing Decision (EU) 2021/1195 as regards harmonised standards for sterilisation of health care products, aseptic processing of health care products, quality management systems, symbols to be used with information to be supplied by the manufacturer and requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples
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 2
This Decision shall enter into force on the day of its publication in the Official Journal of the European Union .
Supplementary provisions
ANNEXSupplementary provisions
ANNEX In the Annex to Implementing Decision (EU) 2021/1195, the following entries are added: No Reference of the standard ‘5. EN ISO 11737-1:2018 Sterilization of health care products – Microbiological methods – Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2018) EN ISO 11737-1:2018/A1:2021 6. EN ISO 13408-6:2021 Aseptic processing of health care products – Part 6: Isolator systems (ISO 13408-6:2021) 7. EN ISO 13485:2016 Medical devices – Quality management systems – Requirements for regulatory purposes (ISO 13485:2016) EN ISO 13485:2016/A11:2021 8. EN ISO 15223-1:2021 Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements (ISO 15223-1:2021) 9. EN ISO 17511:2021 In vitro diagnostic medical devices – Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples (ISO 17511:2020)’.
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Commission Decision (EU) 2025/1191 of 21 February 2025 on State aid SA. 33769 – C/2015 (ex NN/2015) (ex CP/2011) implemented by Romania for Târgu Mureş Transylvania Airport (notified under document C(2025) 1127)Commission Decision (EU) 2025/2370 of 21 February 2025 on the State aid measure SA.106107 (2024/N) which Belgium is planning to implement for the lifetime extension of two nuclear reactors (Doel 4 and Tihange 3) (notified under document C(2025) 1070)Commission Implementing Decision (EU) 2025/337 of 20 February 2025 on the harmonised standards for pyrotechnic articles drafted in support of Directive 2013/29/EU of the European Parliament and of the CouncilCommission Implementing Decision (EU) 2025/383 of 20 February 2025 amending Implementing Decision (EU) 2024/2207 concerning certain emergency measures relating to sheep pox and goat pox in Greece (notified under document C(2025) 1248)Commission Implementing Decision (EU) 2025/384 of 20 February 2025 concerning certain emergency measures relating to infection with peste des petits ruminants virus in Hungary and repealing Implementing Decision (EU) 2025/255 (notified under document C(2025) 1249)Council Decision of 18 February 2025 appointing an alternate member of the Management Board of the European Centre for the Development of Vocational Training (Cedefop) for SlovakiaCouncil Decision of 18 February 2025 replacing an alternate member of the Advisory Committee on freedom of movement for workers for CyprusCommission Implementing Decision (EU) 2025/322 of 18 February 2025 amending Implementing Decision (EU) 2016/2323 establishing the European List of ship recycling facilities pursuant to Regulation (EU) No 1257/2013 of the European Parliament and of the Council on ship recyclingCouncil Decision (CFSP) 2025/335 of 18 February 2025 amending Decision 2011/101/CFSP concerning restrictive measures in view of the situation in ZimbabweCouncil Decision (CFSP) 2025/336 of 18 February 2025 amending Decision (CFSP) 2016/1693 concerning restrictive measures against ISIL (Da’esh) and Al-Qaeda and persons, groups, undertakings and entities associated with themCouncil Decision (CFSP) 2025/338 of 18 February 2025 amending Decision (CFSP) 2022/266 concerning restrictive measures in response to the illegal recognition, occupation or annexation by the Russian Federation of certain non-government controlled areas of UkraineCouncil Decision (CFSP) 2025/344 of 18 February 2025 amending Decision (CFSP) 2024/3097 in support of the comprehensive programme on supporting efforts to prevent and combat illicit trafficking of Small Arms and Light Weapons and Conventional Ammunition in South-Eastern Europe
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.
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