Digital documents explicitly regulated for the first time
With the entry into force of the Machinery Regulation (EU) 2023/1230 in 2024, the digital provision of operating instructions and declarations of conformity, as well as a digital contact option, were explicitly mentioned in the legal text for the first time. Until then, the common interpretation was that these documents had to be supplied in printed form – even though this was never explicitly stipulated.
Contradiction between the Machinery Directive and the New Legislative Framework (NLF)
Since both the new Machinery Directive and numerous previously published directives and regulations are based on the New Legislative Framework (NLF), the question arose as to how to deal with this contradiction.
Omnibus Package IV: Resolution of the contradiction
The Omnibus Package IV, published in May 2025, now resolves this contradiction. The European Commission's aim is to make things easier for small and medium-sized enterprises (SMEs) in particular. This also applies to product-related documentation such as operating instructions and declarations of conformity.
Digital form as the norm and digital contact options
In future, digital form will suffice for this purpose. In addition, the obligation to provide a digital contact option will be added for all products.
Exception: Safety information for consumers
One exception remains: for products intended for consumers or likely to be used by them, safety information must still be provided in printed form. This requirement is already familiar from the Machinery Regulation.
Affected directives and regulations
The amendments apply to 13 directives and 8 regulations in the area of product regulation. They have been divided into two separate proposals:
- COM(2025)503 – Proposal for a Directive of the European Parliament and of the Council amending Directives ... with regard to digitization and alignment of common specifications
- COM(2025)504 – Proposal for a Regulation of the European Parliament and of the Council amending Regulations … as regards digitization and common specifications
Outlook: Tailwind for the digitization of technical documentation
This means that there are now fewer and fewer legal obstacles to the further digitization of technical documentation.
Für die genannte Thematik der Digitalisierung der Dokumentation brauchte es ein “Omnibus-Paket”? mit den Ausnahmen für Konsumenten? Das erinnert mich an ein Schild auf einem Stab in einem Steinhaufen mit dem Warnhinweis “Achtung Steinhaufen”. Warum ist der Steinhaufen da? Na ja, damit das Schild stehen bleibt! Oh EU…
Hallo Dieter,
das Omnibus-IV-Paket beinhaltet mehr als nur die Digitalisierung der Dokumentation. So wichtig sind wir nun auch nicht. ;-) Es geht auch um neue Unternehmeskategorieren zur Reduzierung von Verpflichtungen, Vereinfachung von administrativen Aufgaben und weiteren Entlastungen für Unternehmen.
Gruß
Olaf