What are the requirements for vigilance reporting of adverse events for IVDs?

Sep 1, 2023 ... CH-REP compliance deadlines have passed · December 31, 2021 for Class III, Class IIb implantable and active implantable devices · March 31, 2022 ... The List of WHO-prequalified In Vitro Diagnostic products contains diagnostics used to diagnose a number of conditions and diseases, and that have been ... May 26, 2021 ... ... IVDs. In 2017, the EU put into force its new regulations on medical devices and IVD. This development obligated the Swiss government to ... Mar 25, 2024 ... Below are 7 key steps in the CE certification process, from application submission to certificate issuance. Oct 7, 2016 ... An in vitro diagnostic device, or IVDD, means a medical device or a product subject to section 3 of the Medical Devices Regulations that is ... Dec 20, 2024 ... What is an in vitro diagnostic product (IVD)? ... Like other medical devices, IVDs are subject to premarket and postmarket controls. IVDs are ... In vitro diagnostic medical devices (IVDs) are tests used on biological samples to determine the status of a person's health. "In vitro diagnostic medical device' (IVD') means a medical device, whether used alone or in combination, intended by the manufacturer for the in-vitro ... Per Article 26 of Regulation (EU) 2017/745 on medical devices (MDR) and Article 23 of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) ... Dec 19, 2021 ... Progressive roll-out of the In Vitro Diagnostic Medical Devices Regulation ... The In Vitro Diagnostic Medical Devices Regulation that will apply ...