欧盟IVDR过渡期进入倒计时，但超67%企业仍在"危险区"裸奔——2024年最新稽查数据显示， 38%的IVD企业因混淆"遗留设备"与"旧设备"定义，触发欧盟全境下架。

Given the calls for change, criticism, and ongoing consultations, this article sets out the current status of developments ...

Under IVDR, clear and specific IVD intended use criteria are required and introduce significant challenges for manufacturers ...

因此，相比ivdd指令，ivdr新法规下的ce认证对医疗器械厂家的质量体系及产品的安全性、有效性和市场监管等都提出了更为严苛的要求和门槛，同时 ...

格隆汇3月4日丨新产业(300832.SZ)公布，公司乙型肝炎病毒表面抗原测定试剂盒（磁微粒化学发光法）获得了由欧盟公告机构-TüV ...

For device manufacturers, maintaining the utility of their test to reflect a guideline update can be a slower process now under IVDR than it was under IVDD. This largely comes down to the ...