在 MDR/IVDR 的分类体系中，有四条关键标准，犹如四条 “生死线”，精准地衡量着医疗器械和体外诊断器械的风险等级，决定着它们的分类归属 ，这四条标准分别是侵入性深度、持续时间、能量风险和疾病致命性。

获得由TUV南德意志集团签发的IVDR CE最高风险等级Class D认证证书。该证书的有效期至2030年3月2日，证书编号为No. V70 105113 0010 Rev. 00。此次认证意味着 ...

Within the EU IVDR, IVDs have been divided into four classes, based on both their intended purpose and its inherent risks. The four classes are: Class A (low individual risk and low public health ...

For IVDR compliance, Class D IVDs must transition to being compliant under the new regulation by 31 December 2027, Class C by ...

After several high-profile scandals surrounding medical devices, where irresponsible manufacturers’ malpractice in cutting corners showed how easy it was to abuse the Directive, the IVDR came ...

Importance of QIAGEN’s New Regulatory Achievement Securing IVDR certification for the QIAstat ... are classified as Class A ...