New references of harmonized standards for the following harmonization legislation were published in the Official Journal of the European Union by implementing decision:
- Regulation 2016/425 on personal protective equipment (PPE)
- Regulation 2017/746 on in vitro diagnostic medical devices
- Regulation 2017/745 on medical devices
- ErP Directive 2009/125/EC in support of Regulation (EU) 2016/2281
- Low Voltage Directive 2014/35/EU
Regulation 2016/425 on personal protective equipment
Implementing Decision (EU) 2024/2599 was published on 08.10.2024 and entered into force on the same day. The following harmonized standards were published by amending Annex I of Implementing Decision (EU) 2023/941
1. rows 35, 54, 108, 139, 182, 183 and 184 of the table are deleted
2. rows 109 and 110 of the table are deleted
3. the following rows of the table are inserted in consecutive order
"35a. EN 360:2023 Personal fall protection equipment - Fall arresters"
"54a. EN 564:2023 Mountaineering equipment - Rope lanyards - Safety requirements and test methods"
"108a. EN 12841:2024 Personal fall protection equipment - Rope access systems - Rope adjusters"
"109a. EN 12941:2023 Respiratory protective devices - Self-contained open-circuit breathing apparatus - Requirements, testing, marking"
"110a. EN 12942:2023 Respiratory protective devices - Powered filtering devices with full face mask, half mask or quarter mask - Requirements, testing, marking"
"139a. EN 14058:2017+A1:2023 Protective clothing - Garments for protection against cool environments"
"182a. EN ISO 20345:2022, EN ISO 20345:2022/A1:2024 Personal protective equipment - Safety footwear (ISO 20345:2021)"
"183a. EN ISO 20346:2022, EN ISO 20346:2022/A1:2024 Personal protective equipment - Protective footwear (ISO 20346:2021)"
"184a. EN ISO 20347:2022, EN ISO 20347:2022/A1:2024 Personal protective equipment - Occupational footwear (ISO 20347:2021)"
4. the following line is added:
"189.I. EN 50365:2023 Live working - Electrically insulating helmets for work on low and medium voltage installations"
Link to the implementing decision: https://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1732011061163&uri=CELEX%3A32024D2599
This implementing decision was corrected on November 08, 2024 as follows
Link to the corrigendum: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ%3AL_202490712
Page 6, Annex II, introductory part:
Instead of:
'Rows 2, 3, 4, 5 and 16 of the table in Annex II to Implementing Decision
(EU) 2023/941 are replaced by the following:"
it should read:
'Rows 2, 3, 4, 5, 15 and 16 of the table in Annex II to Implementing Decision (EU) 2023/941 are replaced by the following:'.
On page 6, Annex II, amendment to Annex II to Implementing Decision (EU) 2023/941:
Instead of:
"5. EN 172:1994
Personal eye-protection - Sunscreen filters for occupational use
EN 172:1994/A1:2000
EN 172:1994/A2:2001
11.11.2025
16. EN 1731:2006
Personal eye-protection - Fabric eye and face protectors
11.11.2025"
should read:
"5. EN 172:1994
Personal eye-protection - Sun filters for occupational use
EN 172:1994/A1:2000
EN 172:1994/A2:2001
11.11.2025
15. EN 379:2003+A1:2009
Personal eye-protection - Automatic welding filters
11.11.2025
16. EN 1731:2006
Personal eye-protection - Fabric eye and face protectors
11.11.2025„
Regulation 2017/746 on in vitro diagnostic medical devices
Implementing Decision (EU) 2024/2625 was published on October 09, 2024 and entered into force on October 09, 2024. The following harmonized standards were published by amending Annex I of Implementing Decision (EU) 2021/1195 The following clauses are added:
14 EN ISO 13408-1:2024 "Aseptic manufacturing of health care products - Part 1: General requirements (ISO 13408-1:2023)"
15. EN ISO 20916:2024 "In vitro diagnostic medical devices - Clinical performance studies on human test material - Good study practice (ISO 20916:2019)".
Link to the implementing decision: https://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1732011375112&uri=CELEX%3A32024D2625
Regulation 2017/745 on medical devices
Implementing Decision (EU) 2024/2631 was published on 09.10.2024 and entered into force on October 09, 2024. The following harmonized standards were published by amending Annex I of Implementing Decision (EU) 2021/1182 The following point is added:
26th EN ISO 13408-1:2024 "Aseptic manufacturing of health care products - Part 1: General requirements (ISO 13408-1:2023)".
Link to the implementing decision: https://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1732011440521&uri=CELEX%3A32024D2631
ErP Directive 2009/125/EC in support of Regulation (EU) 2016/2281
Implementing Decision (EU) 2024/2638 was published on October 11, 2024 and entered into force on October 11, 2024. The references of the harmonized standard for fan coil units in support of Regulation (EU) 2016/2281, as set out in the Annex to this Decision, are hereby published in the Official Journal of the European Union:
- EN 1397:2021 'Heat exchangers - Water-to-air fan coil units - Test method for determining performance'.
Link to the implementing decision: https://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1732011510423&uri=CELEX%3A32024D2638
Low Voltage Directive 2014/35/EU
Implementing Decision (EU) 2024/2764 was published on October 31, 2024 and entered into force on October 31, 2024. The following harmonized standards were published by amending Annex I of Implementing Decision (EU) 2023/2723:
139a. EN IEC 60238:2018, EN IEC 60238:2018/A1:2018, EN IEC 60238:2018/A2:2021 "Lampholders with Edison thread"
198a. EN IEC 60335-2-51:2023, EN IEC 60335-2-51:2023/A11:2023 "Safety of household and similar electrical appliances - Part 2-51: Particular requirements for fixed circulation pumps for heating and domestic hot water systems"
221a. EN IEC 60335-2-84:2021, EN IEC 60335-2-84:2021/A11:2021, EN IEC 60335-2-84:2021/A12:2023 "Household and similar electrical appliances - Safety - Part 2-84: Particular requirements for appliances for toilets"
299b. EN 60670-21:2007, EN 60670-21:2007/A11:2023, EN 60670-21:2007/A1:2023 "Boxes and enclosures for electrical accessories for household and similar fixed electrical installations - Part 21: Particular requirements for boxes and enclosures with suspension means"
517a. EN IEC 61851-1:2019, EN IEC 61851-1:2019/AC:2023-12 "Conductive charging systems for electric vehicles - Part 1: General requirements"
Lines 139, 198, 221, 299a and 517 will be deleted from the Official Journal on 30.06.2026 and lose the presumption of conformity.
Link to the implementing decision: https://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1732011594054&uri=CELEX%3A32024D2764
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Author
Dipl.-Ing. (FH) Michael Loerzer
Regulatory Affairs Specialist
DEFINITIONS AND ABBREVIATIONS
ErP Directive: Energy related Products Directive
Low Voltage Directive: The Low Voltage Directive defines the essential safety requirements for products within certain voltage limits.
Rope: A rope is a thin cord that is not very stretchy. The term "rope" originates from seafaring and refers to a rope, for example.
In vitro diagnostics: In vitro diagnostics are medical devices that are used to carry out medical laboratory tests on biological samples such as blood, secretions, urine or tissue.
