What is patent protection for IVD inventions?

In vitro diagnostic medical devices are tests used on biological samples to determine the status of a person's health. The industry employs about 75 000 people ... Waters Corporation manufactures IVD medical devices that offer clinical diagnostic laboratories an alternative to LC-MS/MS systems manufactured for clinical ... 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/ ... Our medical device & IVD regulatory experts can help you gain a deep understanding of the applicable regulations and requirements. Surmodics is a leading provider of chemical components for in vitro diagnostic tests and microarrays. We enable sensitive, reproducible, and robust diagnostic ... 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) ... D2a. Investigational In Vitro Medical Device Dossier (IMDD-IVD. The Investigational In Vitro Diagnostic Medical Device Dossier (IMDD-IVD) specifies the content ... 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 ... Register and certificate your Medical Devices and IVD products while collecting all intelligence on clinical evaluation, post-market surveillance and device ... On 26 May 2022, the In Vitro Diagnostic Medical Devices ( IVD ) Directive (98/79/ EC ) was replaced by Regulation ( EU ) 2017/746 on in vitro Diagnostic ...