Article 1
Open ↗Annex I to Implementing Decision (EU) 2020/438 is amended in accordance with the Annex to this Decision.
Source
Commission Implementing Decision (EU) 2021/611 of 14 April 2021 amending Implementing Decision (EU) 2020/438 as regards harmonised standards on biological evaluation of medical devices, packaging for terminally sterilised medical devices, sterilisation of health care products and clinical investigation of medical devices for human subjects
Commission Implementing Decision (EU) 2021/611 of 14 April 2021 amending Implementing Decision (EU) 2020/438 as regards harmonised standards on biological evaluation of medical devices, packaging for terminally sterilised medical devices, sterilisation of health care products and clinical investigation of medical devices for human subjects
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 Annex I is amended as follows: (1) entry 14 is replaced by the following: No Reference of the standard ‘14. EN ISO 10993-16:2017 Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2017)’ (2) entry 16 is replaced by the following: No Reference of the standard ‘16. EN ISO 10993-18:2020 Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process (ISO 10993-18:2020)’ (3) entry 23 is replaced by the following: No Reference of the standard ‘23. EN ISO 11607-1:2020 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019)’ (4) entry 25 is replaced by the following: No Reference of the standard ‘25. EN ISO 11737-2:2020 Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2019)’ (5) entry 34 is replaced by the following: No Reference of the standard ‘34. EN ISO 14155:2020 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)’ (6) the following entry 47 is added: No Reference of the standard ‘47. EN ISO 11607-2:2020 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019)’
Other acts of the same type
Commission Implementing Decision of 12 July 2017 on the publication in the Official Journal of the European Union of the single document referred to in Article 94(1)(d) of Regulation (EU) No 1308/2013 of the European Parliament and of the Council and of the reference to the publication of the product specification for a name in the wine sector (Skalický rubín (PDO))Council Decision (EU) 2017/1247 of 11 July 2017 on the conclusion, on behalf of the European Union, of the Association Agreement between the European Union and the European Atomic Energy Community and their Member States, of the one part, and Ukraine, of the other part, with the exception of the provisions relating to the treatment of third-country nationals legally employed as workers in the territory of the other partyCouncil Decision (EU) 2017/1248 of 11 July 2017 on the conclusion, on behalf of the European Union, of the Association Agreement between the European Union and the European Atomic Energy Community and their Member States, of the one part, and Ukraine, of the other part, as regards provisions relating to the treatment of third-country nationals legally employed as workers in the territory of the other partyCouncil Decision (CFSP) 2017/1253 of 11 July 2017 amending Decision 2012/392/CFSP on the European Union CSDP mission in Niger (EUCAP Sahel Niger)Commission Implementing Decision (EU) 2017/1255 of 11 July 2017 on a template for the description of national systems and procedures to admit organisations to become EURES Members and Partners (Text with EEA relevance. )Commission Implementing Decision (EU) 2017/1256 of 11 July 2017 on templates and procedures for the exchange of information on the EURES network national work programmes at Union level (Text with EEA relevance. )Commission Implementing Decision (EU) 2017/1257 of 11 July 2017 on the technical standards and formats required for a uniform system to enable matching of job vacancies with job applications and CVs on the EURES portal (Text with EEA relevance. )Council Implementing Decision (EU) 2017/1332 of 11 July 2017 amending Implementing Decision 2014/170/EU establishing a list of non-cooperating third countries in fighting illegal, unreported and unregulated fishing, as regards the Union of the ComorosCouncil Implementing Decision (EU) 2017/1333 of 11 July 2017 amending Implementing Decision 2014/170/EU establishing a list of non-cooperating third countries in fighting illegal, unreported and unregulated fishing, as regards Saint Vincent and the GrenadinesCouncil Decision (EU) 2017/1937 of 11 July 2017 on the signing, on behalf of the European Union, and provisional application of the Treaty establishing the Transport CommunityCouncil Implementing Decision (CFSP) 2017/1245 of 10 July 2017 implementing Decision 2013/255/CFSP concerning restrictive measures against SyriaCommission Implementing Decision (EU) 2017/1239 of 6 July 2017 on the recognition of Ethiopia pursuant to Directive 2008/106/EC of the European Parliament and of the Council as regards the systems for training and certification of seafarers (notified under document C(2017) 4555) (Text with EEA relevance. )
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.
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