EU CRA 網路韌性法

EU CRA 網路韌性法合規輔導

台灣出口商進入歐盟市場的網路安全合規路徑

EU CRA(Cyber Resilience Act)自 2024 年 12 月起正式施行,要求所有含數位元素產品在進入歐盟市場前取得 CE 標誌的網路安全合規。積穗科研協助台灣出口商完成產品分類、Annex I 安全要求實作、SBOM 建立、漏洞揭露流程與 72 小時 ENISA 通報機制。

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什麼是 EU CRA?哪些台灣產品受到影響?

EU CRA(歐盟網路韌性法)是歐盟針對所有含數位元素產品(PDE)設定強制性網路安全要求的法規。CRA 的適用觸發條件是「網路連接性」,而非「硬體界接」——凡是能夠直接或間接連接至網路或另一裝置的產品,均受規範。台灣受影響的產品類型包含:IoT 設備、工業控制系統(PLC、SCADA)、網路設備、智慧家電、行動 App、桌面應用程式、瀏覽器擴充套件、嵌入式系統。CRA 將產品分為三類:一般 PDE(自我評估)、重要 PDE Class I(第三方審查)、重要 PDE Class II(強制第三方認證)。

⚠️ 軟體業常見誤解:「OS 層以上純軟體不受 CRA 規範」

這是錯誤的。歐盟官方 FAQ 明確將行動 App 與電腦遊戲列為預設級 PDE 的適用示例,兩者均為純 OS 層以上軟體,與韌體無關。

豁免條件只有一種:純 SaaS(軟體邏輯完全在雲端,裝置端無任何可下載元件)依 CRA Article 2(5)(h) 豁免。但若 SaaS 附帶行動 App、桌面客戶端或瀏覽器擴充套件,該裝置端元件仍適用 CRA

✅ 適用 CRA行動 App(iOS/Android)
✅ 適用 CRA桌面應用程式(.exe/.dmg)
✅ 適用 CRA瀏覽器擴充套件
❌ 豁免純網頁版 SaaS(無裝置端元件)
✅ 適用 CRASaaS + 附帶 App
❌ 豁免完全離線單機軟體

積穗科研輔導成功案例

案例 01
IoT Equipment Exporter

Completed CRA product classification assessment, confirmed as Class I critical PDE, established SBOM, vulnerability disclosure process, and 72-hour ENISA notification mechanism, achieving CE mark cybersecurity compliance.

案例 02
Industrial Automation Equipment Manufacturer

Completed Annex I safety requirements gap analysis, integrated IEC 62443 industrial cybersecurity standard, established a product security update mechanism (minimum 5 years support), and met CRA Class II mandatory third-party certification requirements.

案例 03
Enterprise Security SaaS Vendor (with desktop client)

Initially assumed pure SaaS exemption. Winners Consulting diagnosis confirmed: the Windows/macOS desktop client bundled with the SaaS is a device-side component, subject to CRA default category. Completed SBOM for desktop client, designed security update mechanism, obtained Declaration of Conformity (DoC), and successfully entered European enterprise procurement lists.

案例 04
Mobile App Developer (connecting to enterprise IoT devices)

Confirmed mobile app as CRA Class I (has network connectivity, controls IoT devices). Completed Annex I security requirements gap analysis, SBOM establishment, and vulnerability disclosure policy. Passed EU distributor CRA compliance review and launched on European market on schedule.

積穗科研輔導流程

01

CRA Product Classification and Applicability Assessment

According to CRA Annex III/IV regulations, assess whether Taiwan's export products fall under regulated products with digital elements, determine the product category (General PDE / Class I / Class II), and confirm the applicable compliance path.

02

Annex I Security Requirements Gap Analysis

Conduct a gap analysis against CRA Annex I essential cybersecurity requirements (no known exploitable vulnerabilities, secure by design configurations, access control, encryption, data minimization, integrity protection, resilience, security update mechanisms).

03

SBOM Establishment and Vulnerability Management

Establish an SBOM (Software Bill of Materials) compliant with CRA requirements, set up vulnerability monitoring and disclosure processes, design a 72-hour ENISA notification mechanism, and establish a product security update mechanism.

04

Conformity Assessment and CE Marking

Select the appropriate conformity assessment path based on product category, prepare Technical Documentation, and obtain the Declaration of Conformity (DoC) or third-party certification required for CE marking.

常見問題

When will the EU CRA become mandatory? How much preparation time do Taiwanese exporters have?

The EU CRA will officially come into force in December 2024, but there is a phased transition period: obligations for notified bodies (after 21 months, September 2026), vulnerability reporting obligations (after 21 months), and full enforcement (after 36 months, December 2027). Taiwanese exporters should immediately start assessing product applicability to avoid being banned from entering the EU market after December 2027.

What is SBOM? Why does CRA require its establishment?

SBOM (Software Bill of Materials) is a list of all components that make up a software (open-source libraries, third-party components, self-developed code). CRA requires SBOM because many software vulnerabilities originate from open-source components (such as Log4j), and SBOM allows manufacturers to quickly identify affected products and patch them in a timely manner.

What are CRA Class I and Class II? How are they determined?

Class I critical PDE listed in CRA Annex III include: identity management software, browsers, password managers, VPNs, network monitoring tools, operating systems, routers, firewalls, industrial IoT devices, etc. Class II includes: HSM (Hardware Security Module), smart cards, industrial automation control systems, etc. Products not listed in Annex III are considered general PDE and can be self-assessed.

What are the compliance pathways for Taiwanese exporters under CRA?

Taiwanese exporters have three pathways: 1. EU Authorized Representative (designate a representative within the EU to be responsible for CRA compliance obligations); 2. Conformity with European harmonized standards (adopt harmonized standards such as ETSI EN 18031, presumed to comply with CRA requirements); 3. Third-party certification (mandatory for Class II, conducted by an EU-approved notified body).

What are the consequences of CRA non-compliance?

The maximum penalty for CRA non-compliance is 2.5% of global annual turnover or 15 million Euros (whichever is higher). A more severe consequence is the prohibition of products from being sold in the EU market, which for Taiwanese exporters relying on the European market, the loss far exceeds the fine amount.

What is the relationship between CRA and IEC 62443?

For manufacturers of industrial automation control systems, IEC 62443 is the most direct standard corresponding to the security requirements of CRA Annex I. Obtaining IEC 62443 certification can serve as an important basis for CRA conformity, significantly simplifying the CRA compliance process. Jishui Research provides integrated guidance for CRA plus IEC 62443.

What are the characteristics of Winners Consulting's CRA advisory services?

Winners Consulting is one of the few firms in Taiwan with integrated advisory capabilities for EU CRA, EU AI Act, and IEC 62443. We assist Taiwanese exporters in entering the European market via the most effective path, integrating four EU regulations (CRA + EU AI Act + IEC 62443 + ISO 26262).

Are pure software products subject to CRA? Are applications above the OS layer exempt?

No. Software above the OS layer is subject to CRA as long as it has network connectivity. CRA's triggering condition is 'network connectivity,' not 'hardware interface.' The EU's official FAQ explicitly lists mobile apps and computer games as default-category PDE examples—both are pure OS-layer-above software with no relation to firmware. Desktop applications (with network connectivity), mobile apps, and browser extensions all fall under CRA. The only exemption is pure SaaS (all software logic in the cloud, no downloadable device-side components).

My product is a SaaS but includes a mobile app. Does it need to comply with CRA?

Yes. Pure SaaS is exempt under CRA Article 2(5)(h), but the exemption condition is 'no downloadable device-side components.' If the SaaS includes a downloadable mobile app, desktop client (.exe/.dmg), or browser extension, that device-side component triggers CRA default category or Class I/II requirements. The SaaS core (cloud portion) remains exempt, but the device-side component must comply. Winners Consulting helps clarify which components require compliance and plans the minimum-scope compliance pathway.

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