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SaMD - AI | July 2026
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Click on the title of the "documents" to be redirected to the original website. In the "Summary" column, we've included the key information to help you determine whether the topic is relevant to your products. Enjoy reading!
| Documents | Summary |
|---|---|
| Cyber Resilience Act – Publication of Practical Guide and FAQ Update |
The Commission has updated the FAQs on the implementation of the Cyber Resilience Act (CRA) and published a practical guide to support manufacturers, developers, and businesses in complying with future obligations. The CRA introduces horizontal cybersecurity requirements for products with digital elements, including hardware and software. The main obligations will take effect on December 11, 2027, while reporting obligations are scheduled to begin on September 11, 2026. |
|
AI Omnibus – Entry into Force of Amendments to the AI Act Framework |
The Commission announced the entry into forceof the AI Omnibus, aimed at simplifying certain aspects of the AI Act’s implementation, clarifying timelines, regulatory sandboxes, and compliance issues. The text provides guidance on the phased implementation of requirements for high-risk AI systems and clarifications on the interaction with product regulations. |
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