Products with Digital Elements

As defined by the EU's Cyber Resilience Act (CRA), it refers to any software or hardware product and its remote data processing solutions, whose intended or reasonably foreseeable use includes a direct or indirect logical connection to a device or network.

Taiwan is a crucial partner in the EU supply chain, and many products exported to Europe fall under the CRA's scope. Non-compliance can lead to severe penalties, including fines up to €15 million or 2.5% of the company's total worldwide annual turnover for the preceding financial year (whichever is higher), a ban from the EU market, or product recalls, causing significant damage to revenue and reputation.

The CRA is closely linked to several standards and regulations that provide a path to compliance. Key ones include the IEC 62443 series for industrial automation and control systems security, ISO/IEC 27001 for information security management, ISO/SAE 21434 for road vehicle cybersecurity engineering, and EU regulations like the Radio Equipment Directive (RED) and GDPR.

Winners Consulting is Taiwan's pioneering firm integrating ERM, industrial engineering, technology law, and data science. Our multidisciplinary team, including tech lawyers and ISO lead auditors, helps you seamlessly integrate CRA requirements into your existing ISO certifications, corporate governance, and internal controls, preventing redundant frameworks. We have extensive practical experience assisting semiconductor leaders like TSMC and MediaTek in optimizing cybersecurity and trade secret protection, ensuring the best safeguarding for your products entering the EU market.