What is post-market risk management?

May 27, 2022 ... The EU's new In Vitro Diagnostic Medical Device Regulation (IVDR) "will have a tremendous impact on the MedTech industry". Read more here. 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 ... IVD medical devices are a subject to different regulations and standards to ensure safety, higher quality and reliability of products, processes and services. In March 2023, the IVDR was amended as regards to transitional provisions for certain in vitro diagnostic (IVD) medical devices on Article 110(4) with the ... 'In Vitro Diagnostic (IVD) medical device' means a medical device, whether used alone or in combination, intended by the manufacturer for the in‐vitro ... in vitro diagnostic medical devices ( IVDs ) compliant with the EU in vitro diagnostic medical devices directive (IVDD) can be placed on the Great Britain ... Accordingly, IVDs are devices intended by the manufacturer for the “in vitro examination of specimens […] derived from the human body” and intended “solely or ... ... In Vitro Diagnostic Medical Devices (Directive 98/79/EC)]. Though this report is aimed principally at manufacturers of IVD medical devices, the concepts and ... "In vitro diagnostic medical device' (IVD') means a medical device, whether used alone or in combination, intended by the manufacturer for the in-vitro ... On the other hand, an IVD refers to a medical device, whether utilized independently or in conjunction, designed by the manufacturer to examine specimens ...