What are the requirements for post-market performance follow-up (PMPF) studies under the IVDR?

... in-vitro diagnostic (IVD) medical devices. Form for the registration of manufacturers and devices in vitro diagnostic medical device directive, article 10. 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 ... This Guidance Document was prepared by the Medical Device Authority (MDA) to help the industry and healthcare professionals in their quest to comply with ... 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 ... Stock suppliers of manufacturing equipment and supplies used in the manufacture of in vitro diagnostic products provide off-the-shelf products such as ... (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 ... In vitro diagnostic (IVDs) are typically tests that are used to examine human samples to assist with diagnosing and managing a patient's health. IVDs are ... 'In Vitro Diagnostic (IVD) medical device' means a medical device, whether used alone or in combination, intended by the manufacturer for the in‐vitro ... The In Vitro Diagnostic Regulation (IVDR) is the current European Union (EU) regulatory legislation for placing in-vitro diagnostic devices on the EU market, ... ... In Vitro Diagnostic Medical Devices (Directive 98/79/EC)]. Though this report is aimed principally at manufacturers of IVD medical devices, the concepts and ...