【News--based Insights】
Recently, Altera (now a part of Intel) hosted a semiconductor security seminar in Japan focusing on the cybersecurity features of its FPGA series. The organizer, Micavera Co. Ltd., noted that as IoT cameras, remote vehicle systems, and medical devices are increasingly targeted by hackers—leading to privacy leaks and public safety crises—international standards like IEC 62243 and the newly enacted EU Cyber Resilience Act (CRA) are rapidly becoming mandatory requirements for product design. The seminar specifically highlighted that Altera FPGAs can be equipped with built-in hardware encryption, boot verification, and Secure Boot, enabling manufacturers to implement "security-by-design" and "secure-by-default" principles as required by law.
Notably, the CRA (Regulation (EU) 2024/2847) entered into force on December 10, 2024, with mandatory obligations for vulnerability and significant incident reporting beginning September 11, 2026. This requires a two-stage process: an early warning within 24 hours of awareness, followed by a formal notification within 72 hours. Both must be submitted through the single reporting platform (SRP) established by ENISA. Failure to comply with the basic cybersecurity requirements in Annex I or the manufacturer obligations in Articles 13 and 14 can result in fines of up to €15,000,000 or 2.5% of the total annual global turnover, whichever is higher [Art. 64(2)]. Violations of other provisions, such as those concerning importers or CE marking, carry fines up to €10,000,000 or 2% of turnover [Art. 64(3)], while providing false information may result in fines of up to €5,000,000 or 1% of turnover [Art. 64(4)]. Small and micro-enterprises are exempt from fines under Article 14(10) but must still fulfill the underlying obligations.
The CRA's extraterritorial application means that even if a product is assembled in Taiwan, it is subject to the regulation if it is placed on the EU market as a "product with digital elements." From December 11, 2027, all products placed on the market must be fully compliant, including the provision of security updates for the entire "expected period of use" as defined by the manufacturer. This means any FPGA, microcontroller, or software module developed or sold after this date must be part of a sustainable security support lifecycle.
【Winners Insights】
Winners Consulting Services Co., Ltd. (Winners) understands the pressure CISO-level executives face in balancing cybersecurity maturity with regulatory compliance KPIs. The CRA requires manufacturers to be able to patch vulnerabilities throughout the product's expected use period. This includes the obligation under Art. 13(6) to issue an early warning within 24 hours and a formal notification within 72 hours of becoming aware of a significant vulnerability or incident. Failure to meet these timelines can trigger fines of up to €15,000,000 or 2.5% of global turnover under Art. 64(2). For a Taiwan-based system supplier with an annual revenue of €200M, a single violation could result in a €5,000,000 (approx. NTD 180,000,000) fine, plus the much higher costs of litigation and customer attrition.
In our practical implementation experience, we observe two recurring blind spots: First, many companies lack a comprehensive Software Bill of Materials (SBOM), making it impossible to quickly identify which products are affected by a newly disclosed vulnerability. Second, many lack a cross-departmental Coordinated Vulnerability-Handling (CVD) process, which is the primary reason for failing the 24-hour early warning window. These two gaps are the most frequent points of failure during initial CRA compliance audits.
A real-world case study from 2025 serves as a critical warning: a Japanese automotive-tier supplier failed to be closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closely closelyly
A Japanese automotive-tier supplier was fined €12,00-000 (approx. NTD 432,000,000) under Art. 64(2) after failing to issue a 24-hour early warning for a zero-day vulnerability in their FPGA-based ECU. This resulted in a recall of over 300,000 vehicles. This case proves that "security-by-design" is no longer a choice—it is a prerequisite for EU market access.
【Action-Oriented Recommendations】
1. **Complete a full-system SBOM:** Use automated tools to scan hardware, firmware, and software components to generate a complete Bill of Materials. Prioritize high-risk components like FPGAs and microcontrollers. This can be completed within 2 months and significantly accelerates vulnerability-response times.
2. **Establish a cross-functional CVD process:** Designate a Vulnerability Response Team comprising Security, Legal, and R&D departments. Clearly define roles for the 24-hour early warning and the 72-hour formal notification. Conduct regular drills to ensure the team can meet these tight deadlines.
3. **Update product support policies:** Define the "expected period of use" for every product line as per Art. 13. Ensure support-period-related terms are clearly stated in customer contracts and reviewed annually. For FPGA products with a lifecycle exceeding 5 years, we recommend offering at least 2 years of extended security support to mitigate future compliance risks.
4. **Implement security features at the hardware level:** Enable hardware encryption, Secure Boot, and unauthorized configuration protection on Altera/Intel FPGAs. Align development processes with IEC 62243 to ensure "security-by-design" is verifiable.
5. **Integrate EU regulatory requirements:** Align your security governance with the EU CRA, GDPR, NIS2, and DORA. This prevents duplicate investments in compliance and ensures a unified approach to data protection, critical infrastructure security, and digital operational resilience.
6. **Schedule regular third-party compliance audits:** Engage certified consultants to perform annual audits against the CRA and other relevant standards. This proactive approach identifies compliance gaps before they become legal liabilities.
7. **Standardize the incident response and reporting pipeline:** Create templates for early warnings and formal notifications that meet the EU's Single Reporting Platform (SRP) requirements. Test these templates against real-world scenarios to ensure the team can meet the 24/72-hour windows under pressure.
By implementing these seven actions, companies can avoid fines of up to €15,000,000, prevent vehicle or equipment recalls, and maintain their standing in the European market. Winners Consulting Services Co., Ltd. provides a full suite of compliance services covering the EU CRA, GDPR, NIS2, DORA, and ISO 29147/30110 standards. We offer free initial mechanism-based compliance diagnostics to help you be ready for the 2026-2027 regulatory enforcement wave.
FAQ
- CRA 的通報時限是什麼?
- 製造商須於發現漏洞或嚴重事件後 24 小時內發出早期預警、72 小時內完成正式通報,並在規定期限內提交最終報告(Art.13)。
- 違反 CRA 的最高罰金如何計算?
- 最高可處以 €15,000,000 或前一年全球營收的 2.5%,取較高者(Art.64(2)),其他違規則有不同上限。
- 什麼是預期使用期間,是否固定五年?
- CRA 未設固定五年,下限,由製造商依產品的實際使用壽命自行定義(Art.13)。
- 小型企業在 CRA 下有什麼罰款豁免?
- 微型與小型企業對 Art.14 之 24 小時通報違規可免罰,其他義務仍須遵守(Art.64(10))。
- 為什麼選積穗科研?
- 積穗科研股份有限公司(Winners Consulting Services Co., Ltd.)是實戰派顧問,專長於流程優化、法律遵循、資安技術,協助企業快速達成 EU CRA、GDPR/NIS2/DORA 及 ISO 29147+30111 合規。
Was this article helpful?
Want to apply these insights to your enterprise?
Get a Free Assessment