Background on Harmonized Standards

Harmonized standards are voluntary technical specifications that manufacturers can use to demonstrate conformity with EU legislation, e.g., the MDR and IVDR. When a standard is published in the Official Journal of the European Union (OJEU), manufacturers who apply it are presumed to comply with the legal requirements it covers.

This is the route most manufacturers take, and it is also what most Notified Bodies expect. For example, when a manufacturer claims compliance with the MDR or IVDR quality system requirements, they typically implement EN ISO 13485:2016 to demonstrate conformity. If the manufacturer has fully implemented the standard, they are presumed to conform with the MDR/IVDR quality management system requirements.

How Harmonized Standards Are Developed

The European Commission issues standardization requests to CEN and CENELEC, which then develop the standards through their technical committees.

This process relies heavily on cooperation between the European and international standardization systems.

International Standards Adapted for Europe

Most of the harmonized standards under the MDR and IVDR are based on international standards developed by ISO (which covers most industrial and process-based standards) or IEC (which focuses on electrical and electronic technologies). These are then published in Europe as European Standards (EN) . ‘EN ISO’ standards are published under the cooperation framework known as the Vienna Agreement (CEN–ISO), and ‘EN IEC’ standards under the Frankfurt Agreement (CENELEC–IEC).

This arrangement helps keep European and international standards technically aligned, but it also means that ISO and IEC retain the copyright for the original texts. CEN and CENELEC publish the European versions under agreement with ISO and IEC. Because of this shared ownership, the European Commission cannot freely make those standards public, and that restriction has created growing tension over access and transparency.

European Only Standards

Some standards are developed entirely within the European system, i.e., not dependent upon existing international standards. These “purely EN” standards are owned solely by CEN or CENELEC, and the Commission can reference them freely in the OJEU without ISO or IEC involvement.

Examples are EN 14683:2025 on medical face masks and EN 285 on steam sterilizers. European-only standards are generally created when 1) no suitable international standard exists, or 2) when the available ISO or IEC standard does not fully meet the needs of EU legislation.

Using the above “purely EN” standards as an example:

EN 14683:2025: there is no ISO equivalent to EN 14683, and therefore it was written under CEN/TC 205 (Non-active medical devices) to align with the MDR’s scope and EU health protection context (patient and clinical use).

EN 285: international standards do exist for steam sterilization, but they cover different topics. ISO 17665-1 addresses moist heat sterilization processes and focuses on process validation, while EN 285 specifies performance and design requirements for steam sterilizers used in healthcare facilities. The EU maintained EN 285 as a complementary standard because hospitals, sterilization units, and Notified Bodies needed detailed performance requirements for equipment installed in clinical settings (e.g., chamber volume, load configuration, and cycle control parameters), which ISO 17665 does not address.

Legal Disputes Affecting Harmonized Standards

Court Case C-588/21 P

In March 2024, the Court of Justice of the EU ruled in Case C-588/21 P (Public.Resource.Org and Right to Know v Commission) that harmonized standards referenced in the OJEU form part of EU law, and therefore must be accessible to the public under Regulation 1049/2001.

The case arose after two transparency organisations requested access to several EN ISO harmonized toy-safety standards. The European Commission refused to release them, arguing that they were protected by copyright. The Court annulled that decision and found that there is an overriding public interest in access to harmonized standards once they become part of the EU legal framework. The Court confirmed that copyright protection for standards still exists; however, it cannot be used to prevent public access once a standard is referenced in EU law. In other words, the public has the right to read the standard, even if its commercial use remains protected.

Court Case T-631/24

The above ruling from C-588/21 P forced the Commission to begin granting access to certain harmonized standards upon request. So, discussions began with CEN and CENELEC (and indirectly ISO/IEC) about controlled-access solutions. For example, read-only portals, where harmonized standards can be read online, but not downloaded or reused. And potentially a central EU-portal, possibly hosted through CEN/CENELEC, to meet its legal transparency obligations while still preserving copyright.

However, soon after, the Commission began receiving access requests for international ISO and IEC standards that had not yet been adopted as harmonized standards in the EU. On 27 September 2024, the Commission issued a new decision granting access to some of those non-harmonized international standards, arguing that the same transparency principle should apply.

By extending the logic of Case C-588/21 P beyond OJEU-listed harmonized standards, the Commission triggered a new legal challenge. In December 2024, ISO and IEC filed Case T-631/24 before the General Court, arguing that the C-588/21 P ruling applies only to EU harmonized standards and not to international texts still protected by copyright. In short, ISO and IEC claim that the Commission took the judgment too far.

Pending Actions

Case T-631/24 is still pending. No statements of defense or interim measures have been made public, and the Court registry lists it as “in progress.” The next expected procedural step is the Commission’s statement of defense, followed by further written pleadings and eventually a hearing. The Court has not published any timetable or interim decisions.

Cases of this type often take 18 to 24 months, meaning a judgment may not arrive before late 2026. Until then, OJEU publications are expected to remain limited to European-only EN standards, with ISO and IEC-based standards remaining on hold.

Can It Be Resolved Without Case T-631/24?

Probably not. Once the Commission granted access to several ISO and IEC standards in September 2024, it created a formal, appealable decision under Regulation 1049/2001.

ISO and IEC then exercised their right to challenge that decision before the General Court, which means the matter is now under the Court’s jurisdiction. The Commission cannot simply withdraw the decision or end the case on its own, and ISO and IEC may insist on a ruling to establish a clear legal boundary.

Both sides also have strong reasons to let the case run its course. The Commission seeks legal certainty on how far its transparency obligations extend under Regulation 1049/2001, while ISO and IEC want confirmation that their copyrighted texts cannot be disclosed without consent. Even if they could reach a political compromise, both likely prefer a judicial decision to clarify what EU law actually allows.

Discussion at the European Commission Level

The issue has been discussed repeatedly in EU Commission working groups. In February 2025, both the MDCG Standards Subgroup and the main MDCG Working Group meetings acknowledged the blockage affecting the publication of ISO and IEC-based harmonized standards.

The Commission confirmed that, due to the ongoing legal dispute, only purely EN standards are being submitted for OJEU publication. Stakeholders, including MedTech Europe, Team-NB, and national authorities, expressed concern about the impact on manufacturers, Notified Bodies, and device availability. The Commission noted that the matter is being followed at the highest levels and that efforts are ongoing to find a pragmatic solution, including potential future MDCG guidance on the use of international standards while the blockage continues.

What This All Means in Practice

The two court cases together have produced a standstill for harmonized standards that depend on ISO or IEC content. To avoid triggering further legal disputes, the Commission and European standardization bodies have paused the submission of EN ISO and EN IEC standards for citation in the OJEU.

In practice, this means that new publications now include only purely European EN standards. Manufacturers relying on ISO or IEC-based standards must continue to use them as evidence of “state of the art” compliance, but without presumption of conformity until legal clarity is restored. This situation creates more uncertainty and increases the need for justification in technical documentation.

For manufacturers, the effect of these proceedings is already visible. The list of harmonized standards is expanding more slowly, and most new entries are limited to European-only EN texts that do not mirror international standards. The last publication of EN ISO/IEC standards was in October 2024. The April 2025 and October 2025 publications only included “pure-EU” standards. This creates a widening gap between the standards available for presumption of conformity and those representing state of the art.

Until the Court clarifies how transparency and copyright should be balanced, manufacturers will need to rely more heavily on technical justification within their conformity assessment documentation. For Notified Bodies, this increases the need for case-by-case evaluation and may lead to less consistency across the system.

The discussions recorded in recent MDCG and Standards Subgroup meetings show that the European Commission is aware of this regulatory pressure, but no short-term resolution is expected.