The Malamud Decision
For decades, European product law has been based on a combination of statutory requirements and harmonised standards. This model strikes a balance between legal clarity and technical flexibility and is of central importance, particularly for regulated sectors such as medical technology. However, following the European Court of Justice’s so-called Malamud decision, this system is now coming under increasing pressure, raising the question: will ISO and IEC standards remain the basis for the European state of the art?
What are the New Approach and harmonised standards?
Since 1985, the EU has been pursuing the ‘New Approach’ to facilitate the free movement of goods within the European single market. Instead of laying down detailed technical requirements in law, directives and regulations are limited to fundamental safety and performance requirements that must be met, without prescribing specific technical solutions. This applies to areas of law such as toys, pyrotechnics, machinery, artificial intelligence and also medical devices.
The technical solutions are specified in detail through harmonised standards. These are developed by organisations such as CEN, CENELEC and ETSI on behalf of the European Commission, often incorporating international (ISO/IEC) or national (e.g. DIN, ÖNORM, SN) standards. Within the standards, so-called Z-annexes establish a direct link to the requirements of EU legislation. If such a standard is applied in full, a presumption of conformity arises, i.e. the presumption that a product meets the legal requirements.
Application remains voluntary, but in practice it is usually the most efficient route to compliance. A harmonised standard only acquires legal effect once its reference is published in the Official Journal of the EU (OJ). Until now, however, the actual text of the standard has usually only been accessible for a fee. This practice is to some extent at odds with the principle of the rule of law, according to which laws must be generally accessible, and thus forms the basis of the ongoing legal proceedings involving Carl Malamud.
Who is Carl Malamud and how is he challenging the EU?
Carl Malamud is an American activist and founder of Public.Resource.Org. His aim is to make legally relevant information freely accessible, particularly where it is necessary for compliance with legal requirements.
In the US, the organisation has already secured access to numerous technical standards and other legal compilations, subsequently making them available online free of charge. This open-access approach has repeatedly led to legal disputes with standardisation organisations invoking copyright.
From 2015 onwards, Malamud expanded his activities to Europe. Together with the Irish organisation ‘Right to Know’, he applied for access to four harmonised standards in the field of toy safety. The European Commission rejected this request, citing copyright and economic interests. After the General Court of the EU initially upheld this decision, Malamud brought the case before the Court of Justice of the European Union, thereby raising the fundamental question of whether harmonised standards are, in fact, part of EU law and must therefore be freely accessible.
ECJ ruling & ISO/IEC lawsuit
On 5 March 2024, the ECJ ruled in Malamud’s favour and annulled the European Commission’s rejection. The Court found that the harmonised standards are an integral part of EU law, as the Commission had conferred legal effect upon them through their publication in the Official Journal . As they help
to clarify obligations, access must be guaranteed for citizens and businesses. Consequently, in this specific case, the public interest in publication outweighs commercial interests and copyright. The judgement is formally based on the EU Regulation on access to documents and was handed down as a decision in an individual case; however, it sends a strong signal to the entire standardisation system.
Following the judgement, initiatives were launched by the Commission, CEN/CENELEC and national institutes to make harmonised standards available free of charge via so-called readability platforms.
At the same time, the international standardisation organisations ISO and IEC – which are often the authors of the works in question – voiced strong criticism and, for their part, brought legal action against the European Commission at the end of 2024, arguing that the Commission had exceeded the scope of the ECJ ruling, infringed copyright, and committed a number of procedural errors.
At the end of 2025, further publications in the Official Journal suggested an initial rapprochement between the EU and ISO. In April 2026, however, the ECJ clarified in a separate case that international standards must also be accessible if they are referenced in EU legal acts, thereby reinforcing Malamud’s position once again and even extending the scope of the ruling.
What impact does this have on medtech manufacturers, and what scenarios might they face?
The medical technology sector is heavily reliant on harmonised standards, as the MDR and IVDR define only essential requirements. Even before the Malamud decision, the harmonisation process had been delayed, leading to uncertainties in day-to-day regulatory practice. The ongoing delays in publications in the Official Journal are causing particular problems when it comes to demonstrating the state of the art – as things stand, no further EN ISO / EN IEC standards are being proposed for publication, as copyright issues remain unresolved. Older standards continue to formally confer a presumption of conformity, whilst newer standards often reflect the state of the art but do not yet have legal effect. Manufacturers must therefore choose their strategy carefully and provide well-founded justification to Notified Bodies, authorities and other interested parties.
One likely scenario is a stronger open-access approach, in which harmonised and referenced standards become freely accessible via reading portals or as downloadable files. This would consistently implement the principle of the rule of law, but would require new funding models for standardisation work (e.g. licensing by the EU) from public funds and could negatively impact the independence of the standardisation bodies.
An alternative scenario would be an increasing decoupling from international standards if no compromise is reached with ISO and IEC. The EU could rely more heavily on its own solutions (e.g. Common Specifications), which is likely to reduce industry and expert participation. Furthermore, there is a risk of decoupling from global standards, which could hamper access to international markets. Fragmentation caused by national solutions – and thus a return to the pre-New Approach era – is also conceivable and would place a heavy burden on the EU internal market and its economic operators.
The Malamud decision marks a turning point in the European standardisation system. For medtech companies, this gives rise to both operational challenges and strategic uncertainties. At the same time, it presents an opportunity for greater transparency and broader access to regulatory knowledge. The key factor will be how the EU strikes a balance between openness, quality and economic viability in future, and how flexibly companies respond to this.
Please note that all details and listings do not claim to be complete, are without guarantee and are for information purposes only.
