What are the timelines for reporting incidents to regulatory authorities?

The In Vitro Diagnostic Regulation (IVDR) is the current European Union (EU) regulatory legislation for placing in-vitro diagnostic devices on the EU market, ... The new regulation focuses on a new classification of IVDs into four risk classes, a more precise description of their analytical and clinical performance. Waters Corporation manufactures IVD medical devices that offer clinical diagnostic laboratories an alternative to LC-MS/MS systems manufactured for clinical ... Jul 10, 2014 ... IVDs are categorised as medical devices under the Medicines Act 1981 and suppliers of IVDs are expected to notify Medsafe of any safety issue or ... Oct 3, 2023 ... ... (IVDs) medical devices. LDT companies would need to comply with medical device statutes and regulations including submission requirements ... ... In Vitro Diagnostic Medical Devices (Directive 98/79/EC)]. Though this report is aimed principally at manufacturers of IVD medical devices, the concepts and ... Surmodics is a leading provider of chemical components for in vitro diagnostic tests and microarrays. We enable sensitive, reproducible, and robust diagnostic ... Mar 17, 2025 ... The MDR and IVDR require all medical devices and in vitro diagnostics (IVDs), including those that have been on the EU market for many years, to ... D2a. Investigational In Vitro Medical Device Dossier (IMDD-IVD. The Investigational In Vitro Diagnostic Medical Device Dossier (IMDD-IVD) specifies the content ... * Job Title:IVD / Medical Device Lead Auditor * Complete specific projects ... Medical Device Regulation 2017/745 UK Medical Device Regulation, ISO 13485.