根据新的欧盟法规,DNV认证高风险的 D类设备. DNV certifies high-risk Class D devices under new EU regulations.

美国的一家诊断器制造商选择了DNV,根据欧盟更严格的体外诊断法规认证高风险类 D 设备. A U.S. diagnostics manufacturer has selected DNV to certify high-risk Class D devices under the EU's stricter In Vitro Diagnostic Regulation. 认证过程需要比旧规则更多的临床证据, 使用数字工具来简化合规性并帮助制造商保持进入欧洲市场. The certification process, which requires more clinical evidence than the old rules, uses digital tools to streamline compliance and help manufacturers maintain access to the European market.