IVD performance evaluation

Geregistreerd op: 20 Apr 2023 Berichten: 7

The In Vitro Diagnostic Regulation (IVDR) is a regulation that applies to in vitro diagnostic (IVD) medical devices sold in the European Union. The regulation came into effect on May 26, 2022 and it imposes new requirements for the performance evaluation of IVD medical devices.

Under the IVDR, IVD medical device manufacturers are required to perform a performance evaluation for each of their devices to ensure that they meet the requirements of the regulation. The performance evaluation should include a systematic and comprehensive analysis of the device's performance characteristics, as well as its intended use and clinical relevance.

The IVD performance evaluation should also include a clinical evaluation, which is an assessment of the clinical performance of the device. The clinical evaluation should be based on clinical data that is generated through clinical studies or other sources of clinical evidence, such as scientific literature or post-market surveillance data.

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Geregistreerd op: 27 Mrt 2023 Berichten: 26

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