Article 1
Annex I to Implementing Decision (EU) 2020/439 is amended in accordance with the Annex to this Decision.
Commission Implementing Decision (EU) 2021/609 of 14 April 2021 amending Implementing Decision (EU) 2020/439 as regards harmonised standards on packaging for terminally sterilised medical devices and sterilisation of health care products
Commission Implementing Decision (EU) 2021/609 of 14 April 2021 amending Implementing Decision (EU) 2020/439 as regards harmonised standards on packaging for terminally sterilised medical devices and sterilisation of health care products
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 Annex I is amended as follows: (1) entry 5 is replaced by the following: No Reference of the standard ‘5. 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)’; (2) the following entries 42 and 43 are added: No Reference of the standard ‘42. 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) 43. 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)’.
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Council Decision (EU) 2016/1751 of 20 September 2016 on the conclusion, on behalf of the European Union, of the Amending Protocol to the Agreement between the European Community and the Principality of Andorra providing for measures equivalent to those laid down in Council Directive 2003/48/EC on taxation of savings income in the form of interest paymentsCouncil Decision (EU) 2016/1966 of 20 September 2016 on the position to be adopted, on behalf of the European Union, within the EEA Joint Committee concerning an amendment to Annex XIX (Consumer protection) to the EEA Agreement (Alternative Dispute Settlement System)Decision (EU) 2016/2386 of the Court of Justice of 20 September 2016 concerning the security rules applicable to information or material produced before the General Court in accordance with Article 105 of its Rules of ProcedureCouncil Decision (EU) 2018/2003 of 20 September 2016 on the signing, on behalf of the Union, and provisional application of the Agreement between the European Union and the Government of the Republic of the Philippines on certain aspects of air servicesCommission Implementing Decision (EU) 2016/1685 of 16 September 2016 authorising the placing on the market of products containing, consisting of, or produced from genetically modified maize Bt11 × MIR162 × MIR604 × GA21, and genetically modified maizes combining two or three of the events Bt11, MIR162, MIR604 and GA21, and repealing Decisions 2010/426/EU, 2011/892/EU, 2011/893/EU and 2011/894/EU (notified under document C(2016) 5746) (Text with EEA relevance)Council Decision (CFSP) 2016/1671 of 15 September 2016 amending Decision 2014/145/CFSP concerning restrictive measures in respect of actions undermining or threatening the territorial integrity, sovereignty and independence of UkraineCommission Implementing Decision (EU) 2016/1674 of 15 September 2016 exempting retail supply of electricity and gas in Germany from the application of Directive 2014/25/EU of the European Parliament and of the Council (notified under document C(2016) 5779) (Text with EEA relevance)Decision (EU) 2016/2387 of the General Court of 14 September 2016 concerning the security rules applicable to information or material produced in accordance with Article 105(1) or (2) of the Rules of ProcedureCommission Implementing Decision (EU) 2016/1658 of 13 September 2016 amending Decision 2008/911/EC establishing a list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products (notified under document C(2016) 5747) (Text with EEA relevance)Commission Implementing Decision (EU) 2016/1659 of 13 September 2016 amending Decision 2008/911/EC establishing a list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products (notified under document C(2016) 5748) (Text with EEA relevance)Council Decision of 12 September 2016 adopting the Council's position on the draft general budget of the European Union for the financial year 2017Commission Decision (EU) 2016/1610 of 7 September 2016 on the publication with a restriction in the Official Journal of the European Union of the reference of harmonised standard EN 13383-1:2002 ‘Armourstone: Part 1: Specifications’ in accordance with Regulation (EU) No 305/2011 of the European Parliament and of the Council (Text with EEA relevance)
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