Ce Marking

4 items tagged with "ce-marking"

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Regulations4

EU Medical Device Regulation (Regulation (EU) 2017/745)

EU regulation governing the safety, performance, and market access of medical devices, including software as a medical device.

Regulation

EU In Vitro Diagnostic Medical Devices Regulation (Regulation (EU) 2017/746)

EU regulation governing in-vitro diagnostic medical devices and related software, raising risk classification and clinical evidence requirements.

Regulation

EU Machinery Regulation (Regulation (EU) 2023/1230)

EU regulation setting health, safety, and cybersecurity requirements for machinery and related products, including digital and AI-enabled systems.

Regulation

EU Radio Equipment Directive Cybersecurity Delegated Regulation (EU) 2022/30

EU delegated regulation activating cybersecurity requirements for internet-connected radio equipment, protecting networks, privacy, and against fraud.