Article 1
Open ↗The references of harmonised standards for medical devices drafted in support of Regulation (EU) 2017/745 and listed in the Annex to this Decision are hereby published in the Official Journal of the European Union .
Source
Commission Implementing Decision (EU) 2021/1182 of 16 July 2021 on the harmonised standards for medical devices drafted in support of Regulation (EU) 2017/745 of the European Parliament and of the Council
Commission Implementing Decision (EU) 2021/1182 of 16 July 2021 on the harmonised standards for medical devices drafted in support of Regulation (EU) 2017/745 of the European Parliament and of the Council
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 No Reference of the standard 1. EN ISO 10993-23:2021 Biological evaluation of medical devices - Part 23: Tests for irritation (ISO 10993-23:2021) 2. EN ISO 11135:2014 Sterilization of health care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135:2014) EN ISO 11135:2014/A1:2019 3. EN ISO 11137-1:2015 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd 1:2013) EN ISO 11137-1:2015/A2:2019 4. 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. EN ISO 25424:2019 Sterilization of health care products - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 25424:2018)
Other acts of the same type
Decision (EU) 2018/6 of the European Parliament and of the Council of 12 December 2017 on the mobilisation of the European Globalisation Adjustment Fund following an application from Greece — EGF/2017/003 GR/Attica retailDecision (EU) 2018/7 of the European Parliament and of the Council of 12 December 2017 on the mobilisation of the European Globalisation Adjustment Fund following an application from Finland — EGF/2017/005 FI/RetailDecision (EU) 2018/8 of the European Parliament and of the Council of 12 December 2017 on the mobilisation of the Flexibility Instrument to finance immediate budgetary measures to address the on-going challenges of migration, refugee inflows and security threatsDecision (EU) 2018/9 of the European Parliament and of the Council of 12 December 2017 amending Decision (EU) 2017/344 of the European Parliament and of the Council of 14 December 2016 on the mobilisation of the Contingency Margin in 2017Commission Implementing Decision (EU) 2018/71 of 12 December 2017 exempting the production and wholesale of electricity in the Netherlands from the application of Directive 2014/25/EU of the European Parliament and of the Council on procurement by entities operating in the water, energy, transport and postal services sector and repealing Directive 2004/17/EC (notified under document C(2017) 8339) (Text with EEA relevance. )Decision (EU) 2018/508 of the European Parliament and of the Council of 12 December 2017 on the mobilisation of the European Union Solidarity Fund to provide for the payment of advances in the general budget of the Union for 2018Council Decision (CFSP) 2017/2282 of 11 December 2017 amending Decision 2010/788/CFSP concerning restrictive measures against the Democratic Republic of the CongoCouncil Decision (CFSP) 2017/2283 of 11 December 2017 in support of a global reporting mechanism on illicit small arms and light weapons and other illicit conventional weapons and ammunition to reduce the risk of their illicit trade (‘iTrace III’)Council Decision (EU) 2017/2284 of 11 December 2017 to provide support to States in the African, Asia-Pacific and Latin America and Caribbean regions to participate in the high-level fissile material cut-off treaty expert preparatory group consultative processCommission Implementing Decision (EU) 2017/2288 of 11 December 2017 on the identification of ICT Technical Specifications for referencing in public procurement (Text with EEA relevance. )Council Decision (CFSP) 2017/2315 of 11 December 2017 establishing permanent structured cooperation (PESCO) and determining the list of participating Member StatesCouncil Decision (EU) 2017/2423 of 11 December 2017 on the position to be adopted, on behalf of the European Union, within the EU-Turkey Association Council as regards the amendment of Protocol 2 to Decision No 1/98 of the EC-Turkey Association Council on the trade regime for agricultural products
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.
What to look at next
Browse all EU Legal ActsEvery instrument by type and year, full text free to read section by sectionEuropean Union legislationEU Legal Acts by type and yearGrouped by instrument type and year of enactment, so you can find others of the same kindBrowse by type and yearEuropean Union: what this database coversWhich datasets are here, which official source they come from, and how current they areEuropean Union overview