2026-06-03
24
Against the backdrop of global digitalization and the ever-increasing risks of cyberattacks, the European Union is gradually incorporating cybersecurity requirements into its product regulatory framework. Following the GDPR, which has become a key benchmark for global data protection, the EU has introduced another far-reaching regulation—the Cyber Resilience Act (CRA).
Author: Huayu Enterprise Management - Business Research Department
The CRA is not just a cybersecurity regulation; it has comprehensively driven changes in product design, software development, supply chain management, and the EU market access mechanism. For Taiwanese companies actively expanding into the European market, the CRA is no longer merely a compliance issue, but a crucial strategic matter concerning their competitiveness and international order-taking capabilities.
I. EU Cybersecurity Oversight Upgrades: From Product Verification to Full Lifecycle Management
The CE marking system, familiar to companies in the past, primarily focused on verifying safety, health, and environmental requirements before product launch. However, the CRA has formally incorporated cybersecurity requirements into the EU product compliance system, emphasizing cybersecurity management throughout the product lifecycle. In the future, companies will not only need to meet cybersecurity requirements before product launch but also continuously manage post-launch cybersecurity risks, including:
Cybersecurity is no longer an add-on feature after product development is complete, but a crucial capability that needs to be continuously managed from design to retirement.
Second, "Secure by Design" and "Secure by Default" have become basic requirements.
The CRA explicitly requires products to implement "Secure by Design." This means incorporating cybersecurity controls from the early stages of product design and development, rather than retroactively reinforcing them.
The product is equipped with appropriate cybersecurity protection mechanisms when it leaves the factory, for example:
Whether a product possesses comprehensive cybersecurity design capabilities will directly impact its ability to successfully enter the EU market.
III. Which products may be affected by the CRA?
The CRA regulates products with digital elements (PwDE). Products meeting one of the following criteria may be subject to regulation:
Common products include:
In addition, if the product's functionality relies on cloud services, the related digital services may also become an important area of CRA assessment.
IV. CRA Product Risk Classification System
The CRA differentiates regulatory requirements based on the level of product risk.
1. Default Category : Most products fall into this category. Companies can complete the compliance process through self-compliance assessment.
2. Important Products Class I :
3. Important Products Class II : These products typically require third-party conformity assessment.
4. Critical Products : These belong to the highest risk level and have the strictest regulatory requirements.
V. Manufacturers' responsibility has been significantly increased.
The CRA places significant compliance responsibility on the manufacturer. Even if the final product integrates third-party software, open-source components, or parts from external vendors, the manufacturer remains responsible for the final product's compliance. Therefore, businesses need to:
In the future, supply chain cybersecurity capabilities will become one of the key indicators for brand customers to evaluate suppliers.
Products that do not meet the standards may be unable to enter the EU market.
I. SBOM will become an important tool for enterprise cybersecurity management.
The CRA places particular emphasis on software supply chain security. In the future, companies may need to establish a Software Bill of Materials (SBOM). Through the SBOM, companies can control:
Only when new cybersecurity vulnerabilities (CVEs) are discovered can companies quickly identify affected products and take remedial measures. For electronics manufacturers, IoT device manufacturers, and hardware and software integration companies, SBOM (Site-Based Management Object) will gradually become a basic management requirement.
II. Risks of hefty fines and market bans
The CRA continues the high-intensity enforcement model consistently employed by EU regulations. Companies that violate regulatory requirements may face:
This will have a significant impact on the company's brand and reputation.
III. Three Actions Taiwanese Enterprises Should Take Immediately
1. Product inventory (confirm which products fall within the scope of PwDE):
2. Adopt international cybersecurity standards and establish a systematic cybersecurity management capability (suggested reference):
3. Establish a complete end-to-end cybersecurity governance mechanism for the supply chain, covering :
From GDPR to CRA, the EU is gradually transforming "digital trust" into new international trade rules. In the future, the core of corporate competition will no longer be just price, quality, and delivery time, but also product cybersecurity capabilities, supply chain resilience, and regulatory compliance.
For Taiwanese companies, the CRA is not just a new compliance requirement, but also a crucial ticket to the European market. Companies that establish cybersecurity governance and supply chain management capabilities early on will have the opportunity to gain a competitive edge in the new round of global supply chain restructuring.
-----------------------------------------------------------------------------------------------------------------
Related services:
華宇企管-ISO管理顧問
1 Followers
延伸閱讀
華宇企管-ISO管理顧問
1 Followers