Dr. Catharina Bertram

IVD-Expertin, Biochemikerin

Approval of IVDs (in vitro diagnostic medical devices) in the EU

In vitro diagnostic medical devices (IVDs) are medical devices used to analyze samples derived from the human body. Typically, these products are reagents, kits, instruments, and devices. Software can also be considered as an IVD regarding its intended purpose. When “approving IVDs,” manufacturers must comply with many regulations, laws, and standards. 1. Significant steps for…


In vitro diagnostic medical device performance evaluation: 8 steps to conformity

If manufacturers don’t conduct a legally compliant performance evaluation of their in vitro diagnostic medical device (IVD), they aren’t just running the risk of problems during the authorization process: They are risking patient safety. Therefore, the IVDR sets strict requirements for this performance evaluation. Find out how the requirements of the IVDR for the performance…


Planning sample sizes for clinical studies of medical devices and IVDs: The 6 questions your statistician must answer

If you have to conduct a clinical investigation for your medical device or clinical performance study for your IVD, you won’t be able to avoid sample size planning. And you will need to avoid the following two problems when calculating the sample size: Therefore, you need to accurately identify the exact sample size needed so…