“Digital by Default” in the EU is intended to help reduce bureaucracy – The digital administrative revolution

The paradigm shift: What “Digital by Default” means for Europe

The European Union is facing a crucial paradigm shift in product documentation. With the adoption of the Omnibus IV package by the Committee of Permanent Representatives of the Member States in September 2025, the EU laid the foundation for the comprehensive digitalization of product information. The principle of "digital by default" will replace existing physical requirements for documentation and user manuals. This decision is far more than a technical adjustment of existing regulations – it marks a fundamental change in the relationship between manufacturers, consumers, and regulatory requirements.

The adopted package aims to digitize 20 different EU product directives within the framework of the single market rules and align them with common specifications. Key changes include the digitization of the EU declaration of conformity, digital exchange processes between national authorities and economic operators, and the authorization for manufacturers to provide instructions for use exclusively in digital form. This is complemented by the introduction of a digital contact point for businesses, designed to simplify communication with authorities.

The relevance of this development extends across several dimensions. From an economic perspective, digitalization promises significant cost savings for companies. The European Commission estimates that European companies can save an additional €400 million through the entire Omnibus Package. From an environmental perspective, the measure contributes to resource conservation, as paper consumption in industrial documentation is considerable. At the same time, the initiative raises fundamental questions regarding digital inclusion, consumer protection, and accessibility.

The Danish Minister for European Affairs, Marie Bjerre, welcomed the agreement on behalf of the Council Presidency, stating that too many European companies were spending too much time navigating complex regulations. This statement underscores the political dimension of the reform: deregulation is seen as a key element in strengthening European competitiveness. This article systematically analyzes this development, examining its historical roots, technical mechanisms, and practical implications, and critically assesses its opportunities and risks.

From e-government to digital product: The path to today's reform

The digitization of public administration and regulatory processes is not a sudden phenomenon, but the result of decades of development. The roots of e-government in Europe reach back to the 1990s, when the first initiatives for electronic administration emerged. A milestone was the European Council's Lisbon Strategy in 2000, which formulated the goal of making the EU the most competitive and dynamic knowledge-based economy in the world.

The Malmö Declaration of 2009 marked another crucial turning point. In this declaration, EU member states, prospective EU members, and EFTA states committed themselves to increasing the transparency of government action, facilitating access to public information, and improving participation in government. This commitment formed the basis for the European e-government strategy, which was enshrined in the e-government action plan 2011-2015 and the Digital Agenda for Europe.

In Germany, the Act to Promote Electronic Administration, or E-Government Act, was passed in August 2013. This law obligated public authorities, among other things, to provide electronic access and facilitated the submission of electronic documents and electronic payments in administrative procedures. Simultaneously, national digitization initiatives developed in various member states. Denmark often played a pioneering role in this. With the introduction of MitID and its predecessor system, virtually no postal mail or in-person visits to government offices are necessary in Denmark today.

The EU Services Directive created further European legal frameworks for the development of national e-government solutions. In addition to simplifying administrative procedures and establishing a single point of contact, the introduction of electronic processing was also agreed upon. These developments laid the foundation for the subsequent extension of digital standards to the product sector.

In the context of product documentation, the development of international standards played a central role. The IEC 61406 standard (DIN SPEC 91406) defined the technology for identifying physical objects using digital nameplates and UIDs (Unique Identifiers). The VDI 2770 guideline defined how manufacturer information should be structured in terms of properties, structure, scope, content, and data format. These standards formed the technical basis for digital product documentation, which was later translated into legal requirements.

The COVID-19 pandemic acted as a catalyst for digitalization. It exposed the weaknesses of paper-based systems and highlighted the need for digital alternatives. In this context, the EU intensified its efforts to reduce bureaucracy and promote digitalization. In 2024, the European Commission announced a simplification agenda comprising several omnibus packages. The Omnibus IV package, which governs the digitalization of product documentation, is part of this broader strategy to reduce bureaucratic burdens and harmonize the digital framework.

The building blocks of the reform: From QR codes to the Cyber ​​Resilience Act

The Omnibus IV package is based on several technical and legal mechanisms that, working together, enable the digitization of product documentation. The first key component is the legal anchoring of the "Digital by Default" principle. This principle reverses previous practice: While paper documents were previously the rule and digital versions the exception, digital documents will be the standard in the future. Only in justified exceptional cases will companies be required to provide printed materials to other companies, public authorities, or consumers.

Digitizing the EU Declaration of Conformity is another essential component. The EU Declaration of Conformity is a mandatory document with which manufacturers or their authorized representatives declare that their products comply with EU requirements. By signing the Declaration of Conformity, they assume full responsibility for ensuring that their product complies with applicable EU law. Digitizing this declaration enables faster dissemination, easier updates, and more efficient verification by market surveillance authorities.

A third element is the digital exchange processes between national authorities and economic actors. These processes are based on standardized interfaces and data formats designed to enable seamless communication. The aforementioned VDI guideline 2770 plays a central role here, defining how manufacturer information must be structured to allow exchange between different actors. The data is created in XML format and stored in defined documentation containers.

The permission for manufacturers to provide instructions for use exclusively in digital form is supported by technical solutions. A common method is the use of QR codes affixed directly to the product. These QR codes allow users to access the digital documentation directly with a smartphone or tablet. The documentation can be stored on a cloud platform operated by the manufacturer or the customer. This solution offers the advantage that the documentation can be updated at any time without the need to exchange physical documents.

The digital contact point for businesses is intended to serve as a central hub for communication with public authorities. This concept is part of a broader strategy to simplify administrative interaction. The idea is that businesses will no longer have to communicate individually with numerous different authorities, but can handle all inquiries and reports through a single point of contact.

Alongside the Omnibus IV package, further regulatory developments affecting the digitization of product documentation must be considered. The Cyber ​​Resilience Act (CRA), which entered into force in December 2024, introduces comprehensive cybersecurity requirements for products with digital elements. These products require an EU Declaration of Conformity and CE marking to demonstrate compliance with these requirements. The link between the digitization of documentation and cybersecurity requirements is clear: if documentation is provided exclusively digitally, the systems through which it is accessed must be protected against cyberattacks.

Another key element is the adjustment of company categorization. The Omnibus IV package introduces the category of Small Mid-Caps (SMCs), which includes companies with more than 249 and fewer than 750 employees, provided they either generate annual revenue of more than €50 million and less than €150 million or have a balance sheet total of more than €43 million and less than €129 million. This new category benefits from certain simplifications, for example in the area of ​​data protection. The exemption from the obligation to maintain a record of processing activities under Article 30 of the GDPR, which previously applied to companies with up to 250 employees, will be extended to companies with up to 750 employees.

Between Council and Parliament: The current state of the legislative process

In October 2025, the initiative to digitize product documentation will be at a crucial stage. The Council of the European Union adopted its position on the Omnibus IV package on September 25, 2025. The European Parliament must now formulate its own position before the trilogue negotiations between the Council, Parliament, and Commission can begin. These negotiations are expected to start in the fourth quarter of 2025 and continue until 2026.

According to the Council's position, the implementation period for member states should be extended to 24 months. This means that after the final directive is adopted, member states will have two years to transpose the requirements into national law. For companies, this results in a clear timeline: they must adapt their systems and processes accordingly to ensure that the digital provision of documentation is standard practice from the effective date.

The current context is characterized by an intense debate about the balance between reducing bureaucracy and protecting consumers. The Council of Ministers has essentially maintained its general direction but has provided clarifications regarding access to digitally available information. To guarantee consumer protection, security-relevant information must remain available in paper form if there is a risk of serious harm to consumers. This restriction is crucial because it prevents critical security information from being provided exclusively digitally.

The business community largely approves of the digitalization plans. Bitkom, Germany's digital association, has welcomed the initiative in principle, pointing out that the flood of new EU regulations has led to greater regulatory complexity in the digital economy. Businesses expect digitalization to bring not only cost savings but also efficiency gains through faster processes and improved document searchability.

The technical implementation is already well advanced in many industries. Companies like KSB in the pump manufacturing sector began years ago to equip their products with QR codes that provide access to digital twins. These digital twins contain all data relating to design, setup, installation, commissioning, and operation, as well as maintenance and repair instructions. This information can be expanded throughout the product lifecycle. Such systems already largely meet the requirements that the Omnibus IV package will impose.

The connection to Industry 4.0 is obvious. The digitization of product documentation is a building block in the broader vision of a fully networked production environment. In a smart factory, all information on plant components should be digitally accessible at any time. The regulatory requirement for digital documentation reinforces this trend and creates incentives for investment in the corresponding infrastructure.

Alongside the digitization of product documentation, the EU is pursuing further digitization initiatives. The Digital Omnibus Package, announced for the end of 2025, aims to simplify existing digital regulations in the areas of data, cybersecurity, and artificial intelligence. The European Commission plans, for example, to revise the AI ​​Regulation to facilitate its practical application. In data law, the Data Governance Act, the Regulation on the free movement of non-personal data, and the Open Data Directive are to be more closely integrated. These various initiatives reinforce each other and form a coherent overall picture of a digitized European economy.

Digitalization in action: Application examples from industry

The practical implementation of digital product documentation can be illustrated using several concrete examples. The first example comes from mechanical engineering. The pump manufacturer KSB has implemented a system according to IEC 61406 (DIN SPEC 91406) in which each pump receives an individual QR code, which is affixed directly to the product. This QR code contains a Unique Identifier (UID) and opens a link to the product's digital twin. The digital twin contains all relevant data from the factory: technical specifications, design parameters, installation instructions, operating instructions, as well as maintenance and repair information.

The advantages of this system are numerous. Technicians can access the latest version of the documentation directly on-site using their smartphone or tablet, eliminating the need to carry heavy binders. The documentation is always up-to-date because it is maintained centrally. When a manufacturer releases an update, for example, due to the development of a new maintenance procedure, this information is immediately available to all users. Throughout the product lifecycle, further information can be added, such as sensor status data or maintenance reports. This creates comprehensive digital documentation of the product's entire life history.

A second example comes from the waste management industry. A company specializing in the disposal of hazardous materials has implemented a QR code-based process control system. The materials undergo multi-stage processes in which they are disassembled into their individual components and ultimately destroyed. The variety of materials is high, and for safety and accounting reasons, each process step must be individually documented. The new system enables real-time tracking of the materials. Each material is assigned a QR code, which is scanned at various stations throughout the process. This makes it possible to know at any given time where each material is located and which processing steps have already been completed.

Measurements taken during the initial phase showed a reduction in documentation costs of between 20 and 30 percent. In addition, there are qualitative advantages such as significantly improved safety in waste disposal. Real-time traceability enables rapid responses to problems and continuous process optimization. This example demonstrates that digitizing documentation not only facilitates access to information but also enables fundamental improvements in process control.

A third example concerns the pharmaceutical industry, where documentation is particularly strictly regulated. Manufacturers are required to maintain comprehensive dossiers on their products, covering all aspects from development and production to application. Digitizing these dossiers allows regulatory authorities to grant approvals more quickly, as the information is structured and searchable. Changes to the documentation can be efficiently tracked, since versioning systems automatically record when and by whom each change was made. This increases transparency and facilitates audits.

In practice, however, the question also arises as to how companies manage the transition from paper-based to digital documentation. One approach is gradual digitization. Companies begin with new products, which are shipped with digital documentation from a specific cut-off date. For existing products, the paper documents are digitized step by step. Specialized service providers offer scanning services in which entire production facilities or individual manuals are digitized and structured. The cost for creating a digitized manual with 100 pages is approximately €5 per page. Converting 30 fully filled binders of technical equipment into structured digital documentation costs approximately €600 per binder.

Industry focus areas: B2B, digitalization (from AI to XR), mechanical engineering, logistics, renewable energies and industry

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Hurdles and concerns: A critical analysis of the digitization plans

Despite the obvious advantages of digitalization, there are legitimate concerns and controversies that require a nuanced consideration. A key problem is the digital divide. Not all population groups have equal access to digital technologies or the ability to use them. Older people, people with low socioeconomic status, people in rural areas, people with a migration background, and people with disabilities are particularly at risk of being excluded from digital services.

Studies on digital inclusion show that digitalization can become a societal problem for older people if access barriers are not removed. The everyday relevance of digitalization is increasing as more and more public services and information are provided exclusively online. If product documentation is also only available digitally, this can lead to certain population groups no longer being able to use products safely because they lack access to the instruction manuals.

The exception provided for in the Omnibus IV package, which stipulates that safety-related information must remain available in paper form if there is a risk of serious harm to consumers, only partially mitigates this problem. Firstly, the definition of what constitutes serious harm is open to interpretation. Secondly, the regulation only applies to safety-related information, not to other important content such as operating instructions or maintenance guidelines.

A second problem concerns the dependence on functioning infrastructure. Digital documentation requires users to have internet access and a working device. In emergency situations, such as power outages, access to digital documentation can be restricted or impossible. Power outages can lead to data loss, especially if servers and storage systems are not protected by uninterruptible power supplies. For companies that do not maintain adequate backup systems, a power outage can render critical documentation temporarily or permanently inaccessible.

Cybersecurity presents a further challenge. When documentation is provided exclusively digitally, new attack vectors for cybercriminals emerge. A hacker attack on a manufacturer's systems could lead to documentation being manipulated or deleted. The Cyber ​​Resilience Act addresses these risks through comprehensive cybersecurity requirements, but implementing these requirements demands significant investment and expertise.

Data protection concerns are also relevant. When users access digital documentation, personal data such as IP addresses, access times, and user behavior can be collected. Manufacturers could use this data for various purposes, such as marketing or product improvement. Without clear regulations and effective control mechanisms, there is a risk of misuse. Paradoxically, the proposed changes to the GDPR, intended to reduce documentation requirements for SMEs and SMCs, could decrease transparency and accountability in the handling of personal data.

Consumer protection organizations fear that simplifying documentation requirements will compromise consumer protection. The Federation of German Consumer Organizations (VZBV) has criticized various aspects of the digitalization agenda, emphasizing that simplifications must not come at the expense of consumer protection. Specifically, they fear that reducing bureaucratic requirements could lead to important information no longer being provided, or only being provided inadequately.

The question of costs requires a nuanced approach. While companies benefit from savings in printing and shipping, new costs arise for the development and operation of digital systems. Digitizing a company can demand significant investment. Simple projects start at around €5,000, while more complex digitization projects can cost €25,000 or more. Ongoing operating costs for hosting, maintenance, and support are additional. For small and medium-sized enterprises (SMEs), these costs can represent a considerable burden, even if they are expected to be offset by efficiency gains in the long run.

Another point of criticism concerns the readability and usability of digital documentation. Not all users find it comfortable to read instructions on small screens. For complex products that require extensive documentation, navigating lengthy digital documents can be more difficult than browsing a printed manual. The quality of the digital user experience depends heavily on the design of the digital platforms. Poorly designed systems can undermine user acceptance.

What's next? Trends from AI to the Digital Product Passport

The digitization of product documentation is part of a broader trend that will gain momentum in the coming years. A key trend is the further development of the Digital Product Passport. In the long term, the Digital Product Passport is intended to replace the declaration of conformity and provide product information and proof of conformity efficiently and with easy access. It will improve traceability and facilitate an overview of compliance with legal requirements. This should further enhance product safety and simplify the management of documentation.

The Digital Product Passport is expected to contain not only documentation but also data on the product's sustainability, such as information on materials used, energy consumption in the production process, and recyclability. This information will be equally relevant for consumers, authorities, and recycling companies. The European Commission is working on developing the corresponding standards, which are expected to be introduced gradually in the coming years.

Another trend is the increasing integration of artificial intelligence into documentation systems. AI-powered assistants could help users quickly find the information relevant to them by processing natural language queries and providing context-dependent answers. Instead of manually searching through lengthy manuals, users could simply ask, "How do I maintain the pump?" and receive the corresponding instructions. Such systems could also provide multilingual translations in real time, facilitating the cross-border use of products.

The development of augmented reality (AR) and virtual reality (VR) technologies opens up new possibilities for interactive documentation. Instead of viewing two-dimensional drawings or videos, users could view three-dimensional models of the product in AR and have step-by-step instructions projected directly onto the real product. This could be particularly helpful for complex maintenance or repair work. Several companies are already experimenting with such solutions, and with the increasing prevalence of AR-enabled devices such as smart glasses, acceptance is likely to grow.

The European digitalization agenda is expected to intensify further. The Digital Omnibus Package, announced for the end of 2025, will bring further simplifications to digital legislation. The European Commission is planning a comprehensive Digital Fitness Check to examine the interactions of the numerous new laws and identify further simplification needs. This indicates that digitalization is not seen as a one-off project, but as an ongoing process.

Further tightening of regulations is expected in the area of ​​cybersecurity. Experience with the Cyber ​​Resilience Act will reveal areas where improvements are needed. It is likely that the requirements for the security of digital documentation systems will increase over time, particularly as security incidents occur. The European Union Agency for Cybersecurity (ENISA) will play an increasingly important role in developing standards and monitoring their implementation.

The trilogue negotiations on Omnibus Package I, which concern amendments to the Corporate Sustainability Reporting Directive (CSRD) and the Corporate Sustainability Due Diligence Directive (CSDDD), are running in parallel and are expected to be concluded by the end of 2025 or the beginning of 2026. The results of these negotiations will shape the framework for sustainability reporting and could also have an impact on product documentation, for example, if sustainability information needs to be integrated into digital product passports.

A potential paradigm shift could be triggered by technological developments in the field of decentralized systems. Blockchain technology could be used to create tamper-proof digital documentation where every change is transparently traceable. This would increase trust in digital documentation and could be particularly relevant in highly regulated industries such as pharmaceuticals or aviation.

The development of the European digital identity (eIDAS 2.0) will lay the foundation for secure digital transactions. By autumn 2026, all EU member states are required to provide their citizens with digital wallets in which documents such as identity cards or driver's licenses can be stored electronically. This infrastructure could also be used for authentication when accessing protected product documentation, for example, when certain information should only be accessible to authorized professionals.

The environmental impact of digitalization is increasingly coming into focus. While saving paper is a positive development, the digital infrastructure itself consumes significant amounts of energy. Data centers providing cloud services are among the largest electricity consumers. The question of how digitalization can be made environmentally sustainable will gain importance in public debate. This could lead to demands for energy-efficient systems and the use of renewable energy for data centers.

Conclusion: Opportunities, risks, and the European path

The EU's decision to introduce the "digital by default" principle for product documentation marks a turning point in European economic regulation. Analysis has shown that this development stems from a decades-long tradition of e-government initiatives and is part of a broader digitalization and deregulation agenda. The technical mechanisms, from QR codes and cloud platforms to standardized data formats, are largely mature and are already being used by innovative companies.

The practical advantages of digitalization are evident. Companies benefit from cost savings, efficiency gains, and improved opportunities for updating and maintaining documentation. Users gain access to up-to-date information that is searchable and can be enhanced with multimedia. The environment benefits from the reduction in paper consumption, although the ecological impact of digital infrastructure must also be considered.

At the same time, the challenges and risks should not be underestimated. The digital divide threatens to disadvantage certain population groups if effective measures to promote digital inclusion are not taken. The dependence on functioning infrastructure and the cybersecurity risks necessitate significant investments in robust systems. Data protection issues must be carefully addressed to prevent misuse. A balance must be struck between reducing bureaucracy and protecting consumers.

The exception for security-relevant information, which must remain available in paper form, is an important safeguard, but it must be clearly defined and consistently implemented. Supervisory authorities will play a central role in monitoring its implementation. It will be crucial that they have sufficient resources and expertise to perform their tasks effectively.

Future developments will depend on several factors. Technological innovations, particularly in artificial intelligence and augmented reality, will open up new possibilities for intuitive and user-friendly documentation. European regulations will continue to evolve, and the Digital Fitness Check will reveal where further adjustments are needed. Experience gained from implementing the Omnibus IV package will provide valuable insights that can be incorporated into future regulations.

From a broader perspective, the digitization of product documentation reflects a fundamental societal shift. The question is no longer whether digitization will happen, but how it will be shaped. The decision for "digital by default" is a conscious decision to move towards a digitized economy and society. This decision offers immense opportunities for efficiency, innovation, and sustainability. However, it also requires an awareness of the associated risks and a willingness to address them proactively.

The European response to the challenges of digitalization differs from the approaches of other regions of the world in its strong focus on regulation and standards. While other regions often rely on self-regulation of the economy, the EU pursues an approach that establishes clear legal frameworks. This can lead to greater legal certainty, but also carries the risk of overregulation. The success of this approach will be measured by its ability to foster innovation without neglecting the legitimate interests of consumers and vulnerable groups.

The Danish Presidency of the Council of the EU has declared digitalization and the reduction of bureaucracy as priorities. The motto “A strong Europe in a changing world” expresses the EU's need to assert itself in global competition. The digitalization of product documentation is one component of a broader strategy to strengthen Europe's competitiveness. However, this strategy must be inclusive and involve all segments of the population.

In conclusion, the introduction of “digital by default” for product documentation is an ambitious and far-reaching undertaking that requires careful implementation. Its success will depend on overcoming the technical, legal, and social challenges and creating a system that meets the needs of all stakeholders. The coming years will show whether the EU can truly create a more competitive Europe with this approach, without neglecting the values ​​on which European integration is based.

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