What are the requirements for the summary of safety and clinical performance (SSCP) under the IVDR?

Any Medical Device or In Vitro Diagnostic reagents manufacturer seeking to market their product in China must apply for and acquire the Medical Device ... Jul 19, 2022 ... In vitro diagnostic medical device ... A medical device is an in vitro diagnostic medical device (IVD) if it is a reagent, calibrator, control ... Brazil IVD classification rules · Class I: Low risk to the individual and low risk to public health · Class II: Medium risk for the individual and: or low risk ... The new regulation focuses on a new classification of IVDs into four risk classes, a more precise description of their analytical and clinical performance. Jan 5, 2023 ... The proposed CRA which was published by the European Commission on September 15, 2022, excludes medical devices and IVDs governed by the Regulation (EU) 2017/ ... The new IVDR, like Regulation 2017/745 (MDR), adapts EU legislation to technological progress, medical developments and progress in lawmaking. On the other hand, an IVD refers to a medical device, whether utilized independently or in conjunction, designed by the manufacturer to examine specimens ... Jan 23, 2023 ... Every month we'll bring you the latest medical device and IVD industry news, useful articles and resources, expert advice, training, and events for your ... Registration of medical devices and in vitro diagnostic devices. This concerns the registration (notification) of Dutch manufacturers or authorised ... In-Vitro Diagnostic Device Regulation (IVDR) becomes effective May 26, 2022 ... medical Devices (IVDs) has been successfully designated under EU IVDR. This ...