Article 1
Open ↗The Annex to Implementing Decision (EU) 2021/1182 is amended in accordance with the Annex to this Decision.
Source
Commission Implementing Decision (EU) 2022/6 of 4 January 2022 amending Implementing Decision (EU) 2021/1182 as regards harmonised standards for biological evaluation of medical devices, 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, processing of health care products and home light therapy equipment
Commission Implementing Decision (EU) 2022/6 of 4 January 2022 amending Implementing Decision (EU) 2021/1182 as regards harmonised standards for biological evaluation of medical devices, 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, processing of health care products and home light therapy equipment
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
Open ↗This Decision shall enter into force on the day of its publication in the Official Journal of the European Union .
Supplementary provisions
ANNEXSupplementary provisions
Open ↗ANNEX In the Annex to Implementing Decision (EU) 2021/1182, the following entries are added: No Reference of the standard ‘6. EN ISO 10993-9:2021 Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2019) 7. EN ISO 10993-12:2021 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2021) 8. 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 9. EN ISO 13408-6:2021 Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2021) 10. EN ISO 13485:2016 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016) EN ISO 13485:2016/A11:2021 11. EN ISO 14160:2021 Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization process for medical devices (ISO 14160:2020) 12. 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) 13. EN ISO 17664-1:2021 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: Critical and semi-critical medical devices (ISO 17664-1:2021) 14. EN IEC 60601-2-83:2020 Medical electrical equipment - Part 2-83: Particular requirements for the basic safety and essential performance of home light therapy equipment EN IEC 60601-2-83:2020/A11:2021’.
Other acts of the same type
Council Decision (EU) 2018/538 of 7 December 2017 on the signing, on behalf of the Union, and provisional application of Amendment 1 to Memorandum of Cooperation NAT-I-9406 between the United States of America and the European UnionCommission Implementing Decision (EU) 2017/2266 of 6 December 2017 amending Implementing Decision (EU) 2016/1138 as regards certain deadlines for the use of UN/Cefact standards in the exchange of information on fisheries (notified under document C(2017) 8089)Commission Implementing Decision (EU) 2017/2286 of 6 December 2017 on the recognition of the requirements of the Eco-Lighthouse environmental management system as complying with the corresponding requirements of the eco-management and audit scheme (EMAS) in accordance with Article 45 of Regulation (EC) No 1221/2009 of the European Parliament and of the Council on the voluntary participation by organisations in a Community eco-management and audit scheme (notified under document C(2017) 8082) (Text with EEA relevance. )Commission Implementing Decision (EU) 2017/2238 of 5 December 2017 on the equivalence of the legal and supervisory framework applicable to designated contract markets and swap execution facilities in the United States of America in accordance with Regulation (EU) No 600/2014 of the European Parliament and of the Council (Text with EEA relevance. )Council Decision (EU) 2017/2381 of 5 December 2017 on the signing, on behalf of the Union, of the Agreement between the European Union and the Kingdom of Norway on administrative cooperation, combating fraud and recovery of claims in the field of value added taxCouncil Decision (EU) 2017/2389 of 5 December 2017 establishing that no effective action has been taken by Romania in response to the Council Recommendation of 16 June 2017Council Decision (EU) 2017/2429 of 5 December 2017 abrogating Decision 2008/713/EC on the existence of an excessive deficit in the United KingdomCommission Implementing Decision of 4 December 2017 on the publication in the Official Journal of the European Union of an application to amend the specification for a name in the wine sector in accordance with Article 105 of Regulation (EU) No 1308/2013 of the European Parliament and of the Council (Graves (PDO))Council Decision (EU) 2017/2301 of 4 December 2017 on the position to be adopted on behalf of the European Union within the ACP-EU Committee of Ambassadors as regards the implementation of Article 68 of the ACP-EU Partnership AgreementCouncil Decision (CFSP) 2017/2214 of 30 November 2017 amending Decision 2014/512/CFSP concerning restrictive measures in view of Russia's actions destabilising the situation in UkraineCommission Implementing Decision (EU, Euratom) 2017/2220 of 30 November 2017 amending Decision 90/181/Euratom, EEC authorising Italy to use certain approximate estimates for the calculation of the VAT own resources base (notified under document C(2017) 7854)Commission Implementing Decision (EU, Euratom) 2017/2221 of 30 November 2017 amending Decision 2005/820/EC, Euratom authorising the Slovak Republic to use statistics for years earlier than the last year but one and to use certain approximate estimates for the calculation of the VAT own resources base (notified under document C(2017) 7856)
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.
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