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Article
How are IVD Medical Devices classified in EU?
Jul 04, 2022
- Library
- How are IVD Medical Devices classified in EU?
Under the IVDR, devices are divided into Class A, B, C and D, considering the intended purpose of the devices and their inherent risks. Any manufacturer must identify the right risk class for your IVD device(s). Your Notified Body (NB) will check this classification is correct for Class B, C, D devices, and if you are executing pre-market clinical studies then your respective Competent Authorities (CA) may also verify your classification even for Class A devices. As a result it's critical for you be confident of your approach and maintain adequate records for your classification decisions in the technical file.
Download this article today to learn more.