Pressure Equipment Directive 2014/68/EU
Implementing Decision (EU) 2026/79 was published on January 13, 2026 and entered into force on the same day. In accordance with this decision, the Annex to Implementing Decision (EU) 2025/165 is amended. For the first time, harmonized standards based on ISO standards were published again.
Link to the implementing decision: https://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1770707340622&uri=CELEX%3A32026D0079
Link to the informative complete list: https://single-market-economy.ec.europa.eu/document/download/64c71e3a-a553-4902-ba07-ebfca3923b92_en?filename=SummaryListForLegislation_PED%2013.1.2026%281%29.xlsx
Machinery Directive 2006/42/EC
Implementing Decision (EU) 2026/80 was published on January 13, 2026 and entered into force on the same day. In accordance with this Decision, the Annex to Implementing Decision (EU) 2023/1586 is amended.
- Article 1(2) is replaced by the following:
'The references of the standards listed in Annex I, Part 3, point 2, rows 121, 266, 324a, 343, 405, 495, 495a, 502a, 513a, 622a, 671a and 681a to this Decision shall be published in the Official Journal of the European Union or shall remain so, subject to restrictions. - Annex I to Implementing Decision (EU) 2023/1586 is amended in accordance with the Annex to this Decision.
Row 622 of the table is deleted.
The following row 622a of the table is inserted with this new restriction
EN 50434:2014
Safety of household and similar appliances – Particular requirements for mains operated shredders and chippers
Restriction: This harmonised standard does not confer a presumption of conformity, limited to machines where the shredding means can rotate at speeds exceeding 300 r•min-1, with the essential health and safety requirements set out in point 1.1.2. (a) of Annex I to Directive 2006/42/EC, which requires that machinery must be designed and constructed so that it is fitted for its function, and can be operated without putting persons at risk when these operations are carried out under the conditions foreseen, but also taking into account any reasonably foreseeable misuse thereof, as well as point 1.3.3. of Annex I to Directive 2006/42/EC, as regards precautions that must be taken to prevent risks from ejected objects, which shall also consider long objects such as tall trees
Link to the implementing decision: https://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1770707479322&uri=CELEX%3A32026D0080
Link to the informative complete list: https://single-market-economy.ec.europa.eu/document/download/c4aee6e9-e647-4806-aa0d-9feecb171a43_en?filename=SummaryListForLegislation_14.10.2025.xlsx
ATEX Directive 2014/34/EU
Implementing Decision (EU) 2026/82 was published on January 13, 2026 and entered into force on the same day. According to this decision, the Annex to Implementing Decision (EU) 2022/1668 is amended.
Line 22 (EN 13852-1:2013) is deleted and removed from the Official Journal with effect from July 14, 2027.
Line 22a is inserted:
EN 13852-1:2025
Cranes – Offshore cranes – Part 1: General-purpose offshore cranes
Link to the implementing decision: https://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1770707956507&uri=CELEX%3A32026D0082
Link to the informative complete list: https://single-market-economy.ec.europa.eu/document/download/a268d803-abd6-4c6b-b1ed-103504361d81_en?filename=Directive%202014%2034%20EU%20ATEX%20-%20Summary%20list%20as%20xlsx%20file.xlsx
ErP Directive 2009/125/EC and Regulation (EU) 2015/1095
Implementing Decision (EU) 2026/151 in support of Regulation (EU) 2015/1095 was published on January 26, 2026 and entered into force on the same day.
No. 1
EN ISO 22042:2021
Blast chiller and freezer cabinets for professional use – Classification, requirements and test conditions (ISO 22042:2021)
EN ISO 22042:2021/A1:2024
Link to the implementing decision: https://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1770708089355&uri=CELEX%3A32026D0151
ErP Directive 2009/125/EC and Regulation (EU) 2019/1784
Implementing Decision (EU) 2026/153 in support of Regulation (EU) 2019/1784 was published on January 27, 2026 and entered into force on the same day.
No. 1
EN 14717:2024
Welding and allied processes – Environmental check list
Link to the implementing decision: https://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1770708201150&uri=CELEX%3A32026D0153
Medical Devices Regulation 2017/745
Implementing Decision (EU) 2026/193 was published on January 30, 2026 and entered into force on the same day. According to this decision, the Annex to Implementing Decision (EU) 2021/1182 is amended. Harmonized standards based on ISO standards were published again for the first time.
The following entries are added to the Annex to Implementing Decision (EU) 2021/1182:
37.
EN ISO 7197:2024
Neurosurgical implants – Sterile, single-use hydrocephalus shunts (ISO 7197:2024)
38.
EN ISO 10993-4:2017
Biological evaluation of medical devices – Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017)
EN ISO 10993-4:2017/A1:2025
39.
EN ISO 14155:2020
Clinical investigation of medical devices for human subjects – Good clinical practice (ISO 14155:2020)
EN ISO 14155:2020/A11:2024
40.
EN ISO 14630:2024
Non-active surgical implants – General requirement (ISO 14630:2024)
41.
EN ISO 17665:2024
Sterilization of health care products – Moist heat – Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665:2024)
42.
EN ISO 18562-1:2024
Biocompatibility evaluation of breathing gas pathways in healthcare applications – Part 1: Evaluation and testing within a risk management process (ISO 18562-1:2024)
43.
EN ISO 18562-2:2024
Biocompatibility evaluation of breathing gas pathways in healthcare applications – Part 2: Tests for emissions of particulate matter (ISO 18562-2:2024)
44.
EN ISO 18562-3:2024
Biocompatibility evaluation of breathing gas pathways in healthcare applications – Part 3: Tests for emissions of volatile organic substances (ISO 18562-3:2024)
45.
EN ISO 18562-4:2024
Biocompatibility evaluation of breathing gas pathways in healthcare applications – Part 4: Tests for leachables in condensate (ISO 18562-4:2024)
46.
EN ISO 21535:2024
Non-active surgical implants – Joint replacement implants – Specific requirements for hip-joint replacement implants (ISO 21535:2023)
47.
EN ISO 21536:2024
Non-active surgical implants – Joint replacement implants – Specific requirements for knee-joint replacement implants (ISO 21536:2023)
48.
EN ISO 80369-2:2024
Small-bore connectors for liquids and gases in healthcare applications – Part 2: Connectors for respiratory applications (ISO 80369-2:2024, Corrected version 2025-06)
Link to the implementing decision: https://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1770708244071&uri=CELEX%3A32026D0193
Link to the informative complete list: https://single-market-economy.ec.europa.eu/document/download/2dc955f5-4d31-4099-b60a-48000153b29c_en?filename=SummaryListForLegislation_20.10.2025.xlsx
Regulation on in vitro diagnostic medical devices 2017/746
Implementing Decision (EU) 2026/197 was published on February 09, 2026 and entered into force on the same day. According to this decision, the Annex to Implementing Decision (EU) 2021/1195 is amended.
In the Annex to Implementing Decision (EU) 2021/1195, the following entries are added:
18.
EN ISO 17665:2024
Sterilization of health care products - Moist heat - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665:2024)
19.
EN ISO 18113-1:2024
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions, and general requirements (ISO 18113-1:2022)
20.
EN ISO 18113-2:2024
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use (ISO 18113-2:2022)
21.
EN ISO 18113-3:2024
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use (ISO 18113-3:2022)
22.
EN ISO 18113-4:2024
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO 18113-4:2022)
23.
EN ISO 18113-5:2024
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2022)
Link to the implementing decision: https://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1770740548143&uri=CELEX%3A32026D0197
Link to the informative complete list: https://single-market-economy.ec.europa.eu/document/download/a3a5c48d-bd65-48db-9efb-187a1eca2586_en?filename=SummaryListForLegislation_2017_746%201.30.2026.xlsx
Construction Products Regulation 305/2011
Implementing Decision (EU) 2026/284 was published on February 09, 2026 and entered into force on the same day. According to this decision, the Annex to Implementing Decision (EU) 2019/451 is amended.
In the Annex to Implementing Decision (EU) 2019/284, the following entries are added:
13.
EN 1-2:2025
Residential liquid fuel burning appliances – Part 2: Flued oil stoves with vaporizing burners
14.
EN 16510-2-5:2025
Residential solid fuel burning appliances – Part 2-5: Slow heat release appliances
15.
EN 16510-2-7:2025
Residential solid fuel burning appliances – Part 2-7: Combination appliances fired by wood logs and pellets
During the coexistence period (February 09, 2026 - February 09, 2027) EN 13240:2001 and EN 14785:2006 apply to combination appliances fired by wood logs and pellets.
16.
EN 16510-2-10:2025
Residential solid fuel burning appliances – Part 2-10: Multi-firing sauna stoves fired by natural wood logs
17.
EN 17235:2024
Permanent anchor devices and safety hooks
Link to the implementation decision: https://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1770708316883&uri=CELEX%3A32026D0284
Link to the informative complete list: https://ec.europa.eu/docsroom/documents/56834?locale=de
Author's note
This article has been machine translated into English.
