European regulations and digital security

EUROPEAN REGULATIONS AND CYBERSECURITY: A GUIDE FOR BUSINESSES

In recent years, the European Union has introduced a series of new regulations to strengthen the cybersecurity of digital products and ensure the reliable use of artificial intelligence. From the Cyber Resilience Act to the NIS2 Directive, from the RED Delegated Act on the security of radio equipment to the new Machinery Regulation, and on to the upcoming AI Act and Data Act, these regulations redefine obligations and standards for companies in many sectors. This affects a wide audience: from hardware/software engineers involved in design, to quality and compliance managers called upon to adapt processes and documentation, to corporate lawyers and buyers who must ensure that they purchase compliant components.

These new European regulations on digital security affect all companies.

Cyber Resilience Act - Digital security becomes a legal requirement.

• The CRA introduces the principle of security 'by design'.

Digital products must be secure by design and updated throughout their lifecycle. From 2027, those who do not comply will no longer be able to sell in the EU. This regulation directly affects manufacturers, importers and distributors of such products.

The regulation requires compliance with security and vulnerability management requirements, demonstrated through the CE process with technical documentation and an EU declaration of conformity.

The Cyber Resilience Act applies only to products placed on the market after 11 December 2027.
Products already on the market before this date may continue to be sold afterwards, as long as no major changes are introduced.

The European Radio Equipment Directive has introduced new and stringent cybersecurity requirements for wireless devices such as smartphones, IoT and radio connectivity cards, effective from 1 August 2025.

In order to be placed on the market, these devices must incorporate communication protection measures, access control and secure software.

The regulation introduces three essential security requirements:

1. Communication protection – protection of personal data and privacy, preventing unauthorised access or exposure.
   
   
2. Network risk prevention – the device must not damage the network or become an entry point for attacks.
   
   
3. Access and software control – only authorised software may be installed/executed, through security mechanisms such as secure boot and digital signatures.

From 1 August 2025, all radio devices or batches placed on the EU market from this date onwards must comply with the RED cyber requirements. Every new batch marketed after 1 August 2025 must comply with the RED cyber requirements, even if technically identical to earlier versions.

The NIS2 Directive, which effectively came into force in mid-October 2024, applies to organisations operating in critical sectors, from energy to healthcare, public administration to transport, banking to digital infrastructure and many others. It imposes stringent risk management obligations as well as very rapid notification times for cyber incidents (between 24 and 72 hours), with heavy penalties for non-compliance. The Security Manager plays a key role and must be able to handle these critical requirements.

The requirements to be met are:

• ICT policies and technical security measures
• Vulnerability management and updates
• Training and cyber hygiene (internal and supply chain)
• Incident response plans

Micro Systems is registered with the National Cybersecurity Agency platform, a fundamental requirement for ensuring regulatory compliance and strengthening the company's IT security level.

The New Machinery Regulation stipulates that from January 2027, industrial machinery must be safe not only from a mechanical point of view, but also from a digital point of view. AI integrated into machinery will be classified as a high-risk element requiring certification. This regulation updates health and safety requirements to keep pace with technological developments: in a world where machines are increasingly connected, remotely updatable and integrated with artificial intelligence, designing them with digital risks in mind, as well as traditional mechanical ones, is a competitive advantage.

Artificial Intelligence Act – Rules for reliable and secure AI

This act represents the first European regulatory framework on artificial intelligence, designed to ensure trustworthy and transparent systems that respect fundamental rights, with a tiered approach based on risk level. It involves developers, distributors, importers and, to some extent, users (especially for high-risk AI). It covers virtually all AI applications.

Data Act – Governing data generated by connected devices

The Data Act (EU Regulation 2023/2854) is one of the pillars of the European strategy for the data economy. Its aim is to ensure fair and secure access to data generated by connected digital devices, promoting sharing between companies, users and public institutions, while respecting property rights, privacy and competition.

Unlike the CRA or NIS2, which focus on cybersecurity and resilience, the Data Act regulates how data should be accessible, transferable and reusable, particularly between suppliers, customers and authorities.

Conclusions

Many companies still view these regulations as obstacles or remain unfamiliar with their details and implications. In reality, they represent a great opportunity because they allow you to:

• Increase customer and market confidence.
• Differentiate themselves through the use of reliable and certified products.
• Reduce operational and reputational risks.
• Be ready to compete in an increasingly regulated European environment.

Ultimately, these new regulations should be regarded not as a bureaucratic burden, but as an opportunity to innovate, stand out, and build customer trust. The future of competitiveness lies in the ability to combine technology, compliance and security.

What to do now to prepare for the new EU cybersecurity regulations

• Map your products and processes: identify which ones fall under CRA, RED, or Machinery Regulation.
• Integrate security 'by design': design hardware, software and machines with cyber security built in from the outset.
• Update technical documentation: CE files, digital manuals, declarations of conformity.
• Manage vulnerabilities: activate procedures for monitoring and rapid incident reporting (24/72 hours).
• Train staff: developers, technicians, and quality managers must be aware of the new requirements.
• Involve suppliers: request components and modules that are already compliant, so as not to slow down the supply chain.
• Seek out expert partners: rely on those who know the regulations and can guide you step by step.
• Plan ahead: testing and certification take months, so don't wait until 2026/2027.
  
  

What Micro Systems does to support companies in complying with regulations

At Micro Systems, we have always worked with a strong focus on regulations and innovation. We believe that regulatory compliance is not just an obligation, but an opportunity to constantly improve our products and services. We continuously invest in security and compliance, so that we are not chasing regulations and new rules, but anticipating them.

We have already integrated 'security by design' principles, secure update systems and vulnerability management into our projects and prepared the relevant documentation.

Our goal is to accompany our customers on this path of growth, offering components and solutions that are ready-made or easily adaptable to the requirements of new laws.

In this way, we help companies reduce their compliance burden and look to the future with peace of mind and confidence in innovation.

Prepare today for tomorrow's challenges

If you have any specific questions about the compliance of our products or require technical/regulatory support, please do not hesitate to contact us.

Our team is available to work with you to tackle cybersecurity challenges. And successfully overcome them.

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