What are the requirements for the EUDAMED database for IVDs?

In vitro diagnostics (IVDs) are tests that can detect disease, conditions and infections. In vitro simply means 'in glass'. Medical devices and in vitro diagnostic medical devices · MDR · IVDR · New EU Regulation on IVD to take effect on 26 May 2022 · Notification · Free sales ... Any Medical Device or In Vitro Diagnostic reagents manufacturer seeking to market their product in China must apply for and acquire the Medical Device ... Feb 10, 2025 ... The actual classification of a particular device must be considered individually, taking account of its design and use intended by the ... Jul 3, 2023 ... Therefore, there is a need to classify. IVD medical devices based on their risks to patients, users and other persons. The risk presented by a ... (b) for a Class 4 IVD medical device that is an immunohaematology reagent IVD medical device--the relevant Level 2 collective term; and. (c) for a Class 3 ... Sep 8, 2021 ... MedTech Europe Survey Report – Analysing the availability of In vitro Diagnostic Medical Devices (IVDs) in May 2022 when the new EU IVD Regulation applies. Mar 25, 2024 ... Below are 7 key steps in the CE certification process, from application submission to certificate issuance. In vitro diagnostic medical devices (IVDs) are tests used on biological samples to determine the status of a person's health. Register and certificate your Medical Devices and IVD products while collecting all intelligence on clinical evaluation, post-market surveillance and device ...