Article 1
Open ↗Annex I to Implementing Decision (EU) 2020/437 is amended in accordance with the Annex to this Decision.
Source
Commission Implementing Decision (EU) 2021/610 of 14 April 2021 amending Implementing Decision (EU) 2020/437 as regards harmonised standards on medical vehicles and their equipment, anaesthetic and respiratory equipment, biological evaluation of medical devices, packaging for terminally sterilised medical devices, sterilisation of health care products, clinical investigation of medical devices for human subjects, non-active surgical implants, medical devices utilising animal tissues and their derivatives, electroacoustics and medical electrical equipment
Commission Implementing Decision (EU) 2021/610 of 14 April 2021 amending Implementing Decision (EU) 2020/437 as regards harmonised standards on medical vehicles and their equipment, anaesthetic and respiratory equipment, biological evaluation of medical devices, packaging for terminally sterilised medical devices, sterilisation of health care products, clinical investigation of medical devices for human subjects, non-active surgical implants, medical devices utilising animal tissues and their derivatives, electroacoustics and medical electrical 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 Annex I is amended as follows: (1) entry 22 is replaced by the following: No Reference of the standard ‘22. EN 1789:2020 Medical vehicles and their equipment - Road ambulances’ (2) entry 81 is replaced by the following: No Reference of the standard ‘81. EN ISO 10993-16:2017 Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2017)’ (3) entry 83 is replaced by the following: No Reference of the standard ‘83. 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)’ (4) entries 92 and 93 are replaced by the following: No Reference of the standard ‘92. 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) 93. 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)’ (5) entry 96 is replaced by the following: No Reference of the standard ‘96. 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)’ (6) entries 125 and 126 are replaced by the following: No Reference of the standard ‘125. EN 13718-1:2014+A1:2020 Medical vehicles and their equipment - Air ambulances - Part 1: Requirements for medical devices used in air ambulances 126. EN 13718-2:2015+A1:2020 Medical vehicles and their equipment - Air ambulances - Part 2: Operational and technical requirements for air ambulances’ (7) entry 137 is replaced by the following: No Reference of the standard ‘137. EN ISO 14155:2020 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)’ (8) entry 145 is replaced by the following: No Reference of the standard ‘145. EN ISO 14607:2018 Non-active surgical implants - Mammary implants - Particular requirements (ISO 14607:2018, Corrected version 2018-08)’ (9) entries 180 and 181 are replaced by the following: No Reference of the standard ‘180. EN ISO 22442-1:2020 Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2020) 181. EN ISO 22442-2:2020 Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling (ISO 22442-2:2020)’ (10) entry 193 is replaced by the following: No Reference of the standard ‘193. EN IEC 60118-13:2020 Electroacoustics - Hearing aids - Part 13: Requirements and methods of measurement for electromagnetic immunity to mobile digital wireless devices’ (11) entry 208 is replaced by the following: No Reference of the standard ‘208. EN 60601-2-4:2011 Medical electrical equipment - Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators’ (12) the following entries 265 to 268 are added: No Reference of the standard ‘265. EN ISO 5361:2016 Anaesthetic and respiratory equipment - Tracheal tubes and connectors (ISO 5361:2016) 266. EN IEC 60601-2-66:2020 Medical electrical equipment - Part 2-66: Particular requirements for the basic safety and essential performance of hearing aids and hearing aid systems (IEC 60601-2-66:2019) 267. 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 268. EN ISO 80601-2-55:2018 Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors (ISO 80601-2-55:2018)’
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Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.
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