In 2018, the European Commission rejected an application by two non-profit organizations, Public.Resource.Org Inc. and Right to Know CLG, which campaign for the free accessibility of law, for access to several technical standards under the Access to Documents Regulation (EC) No. 1049/2001. In 2021, the General Court of the European Union initially confirmed the Commission's legal opinion. However, following an appeal, the European Court of Justice (ECJ) in Luxembourg overturned the first ruling on March 5, 2024 in the so-called "Malamud" ruling (Case C-588/21 P) and declared that the Commission should have granted access to the harmonized standards (hEN). As a result, the national standards organizations have set up reading portals for accessing certain harmonized standards.
On December 6, 2024, ISO and IEC initiated proceedings against the European Commission before the ECJ (case number T-631/24). In the present application, IEC and ISO point out that the ECJ ruling of March 5, 2024 is limited exclusively to standards harmonized in the EU (listed in the Official Journal) and that access to international standards was not the subject of the ruling. Both organizations accuse the Commission of failing to examine whether there was any public interest in the dissemination of international standards from ISO and IEC. Such an interest, which would affect the commercial interests and intellectual property of IEC and ISO, would not be recognized. The Commission should therefore have rejected applications for access to standards relating to international standards (EN ISO, EN IEC).
In addition, IEC and ISO accuse the Commission of causing them to lose their intellectual property by making the standards accessible, which the Commission should have protected under Article 17 of the Charter of Fundamental Rights of the European Union. Furthermore, the Commission failed to pay IEC and ISO adequate compensation for the loss of their intellectual property in due time.
Furthermore, the Commission violated the principle of proportionality enshrined in Article 5 of the Treaty on European Union (TEU). By deciding to promulgate standards that went far beyond the scope of the judgment and regardless of whether it was correct to promulgate international standards, the Commission caused far greater harm than necessary to the two standardization organizations IEC and ISO. The same applies to the decision to make the standards globally available to all applicants without taking into account whether an applicant is itself subject to EU law (i.e. resides in the EU).
Finally, Regulation (EC) No. 1049/2001 (Access to Information Regulation) also stipulates that the Commission must consult third parties if ambiguities arise in the context of the examination of the existence of an overriding public interest. Here too, the Commission had failed to consult IEC and ISO. How the ECJ will react to this is still completely open.
As a result of these circumstances, no more harmonized standards with an ISO or IEC reference have been published in the EU Official Journal since the beginning of this year! The last publication with an IEC reference was EN 60456/A12:2023 (Commission Implementing Decision (EU) 2025/72 of January 15, 2025). Furthermore, there are no references to hEN with ISO/IEC reference in the DIN Media GmbH reading portal.
This applies in particular to harmonization legislation such as machinery, low-voltage, EMC, ATEX directives or the Medical Devices Regulation, as the majority of hENs are based on ISO/IEC. This also makes global market access more difficult, as the corresponding ISO/IEC standards are often the basis for certification procedures.
The CEN-CENELEC Management Center (CCMC) is trying to find a solution here. No information is currently available in the public domain. It therefore remains to be seen whether a solution will be found in the near future.
One fall-back option could be the so-called "common specifications", which are already part of the Medical Devices Regulation 2017/745 or the new Machinery Regulation 2023/1230. In the Omnibus Package IV, some important sectoral regulations relating to digitalization and these common specifications are to be adapted in a horizontal legal act (see COM(2025) 503 final and COM(2025) 504 final). However, this would not be a sensible solution in the context of global markets, as such common specifications would lead to considerable problems globally in the very different market approval systems (e.g. in the USA or China), as they would not be accepted.
This entire Malamud problem therefore poses challenges for the European industry with regard to conformity assessment procedures.
Standard users, who have so far relied heavily on hENs listed in the Official Journal, need to rethink their approach. The following basic principle applies:
"Legal conformity takes precedence over conformity to standards"
As a reminder: With regard to harmonization legislation, this basically means that the essential requirements defined in each case must first be met (see also the EU Blue Guide). This also means that the "state of the art" must be taken into account.
Example Low Voltage Directive 2014/35/EU, Article 3 sentence 1:
"Electrical equipment may be made available on the Union market only if it is manufactured in such a way that, when properly installed and maintained and used for its intended purpose, it does not endanger the health and safety of persons, domestic animals or property, in accordance with the state of the art in safety technology in the Union."
At least, but not exclusively, sentence 2 of Article 3 refers to the most important safety objectives in Annex I of the Low Voltage Directive:
"Annex I contains a summary of the most important information on the safety objectives."
Recommendations for action:
- Determine the minimum relevant essential requirements for a product from the relevant harmonization legislation and evaluate them on the basis of a risk assessment.
- The state of the art (and science) must also be taken into account (also with regard to producer and product liability).
- Determine and check whether there are applicable and recognized technical rules for the product.
- New: Until now, many manufacturers have relied on hENs listed in the Official Journal in order to derive the presumption of compliance with the essential requirements. Due to the current situation described above, this approach is obviously no longer effective or involves certain risks. We therefore propose the following strategy:
- Case 1: For older hENs, check whether there are successor versions or amendments (abbreviated as A...) that have not yet been listed in the EU Official Journal. It may be useful to look at the ISO/IEC level. Carry out a gap analysis to determine whether the new version or amendment better reflects the state of the art (or parts of it). As a result, a decision must be made as to whether a combination of both standard versions or the complete new version or possibly even the older version (if the new version has deficiencies or other reasons speak against its application) should be used. The respective justifications must be documented in the technical documentation (exonerating effect in the event of damage).
- Case 2: In the case of new standardization topics where there are no previous versions, the ISO/IEC version in particular should be checked to see whether it reflects the state of the art. It may also be possible to check whether there is a corresponding EN version, which may have a mandate from the EU. In this case, the gap analysis is not necessary. Nevertheless, the standard users must assess whether this standard(s) is/are suitable as part of the risk assessment.
It is important to explain this background to developers and designers and to provide them with suitable resources (time, tools), as these people also have a design responsibility.
Would you like to read more about the Malamud case or harmonized standards? Then you can find more articles here:
→ HAS assessment sheets for EN IEC 62368-1:2024 + A11:2024 from September 10, 2025
→ Common specifications (CS) of the EU January 14, 2025
→ EU: "Malamud" case and CJEU ruling on March 5, 2024 from February 01, 2024
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Author's note
This article has been machine translated into English.
