Implementation of the In Vitro Diagnostic Device Regulation for CE Marking Training Course
Course Aim: To help implement the requirements of the European In Vitro Diagnostic Device Regulation (IVDR 2017/746) to obtain and maintain the CE mark for your product. Gain confidence with the IVD classification rules and the conformity assessment routes. Learn the importance of the General Safety and Performance Requirements in product development, and of scientifically robust performance evaluation and clinical evidence. Explore the role of risk management during product development and in post market follow up. Develop an understanding of the interface and interaction with Notified Bodies, economic operators (importers, distributors, EU Representatives) and subcontractors/suppliers, according to their obligations under the IVDR.
Course Description: The In Vitro Diagnostic Devices Regulation (IVDR 2017/746) is the legislation detailing the requirements which manufacturers have to meet to place in vitro diagnostic devices on the market in the European Union.
The Regulation contains detailed requirements that need to be implemented, and will affect all IVD manufacturers, importers, distributors and EU Representatives.
The IVDR focusses on devices to be safe and effective, emphasizing pre-market requirements, conformity assessment, post-market-surveillance (PMS), and traceability.
This course aims to offer guidance on implementation of the requirements stipulated in the IVDR into your business.