Requirements and Implementation of the In vitro Diagnostic Regulation for CE Marking training course
Learn about the key requirements of the new In Vitro Diagnostic Regulation (IVDR EU 2017/746), published in Spring 2017 with a five year transition period. To CE mark an IVD in Europe it will soon be mandatory to conform to this Regulation. The Regulation will affect all In Vitro Diagnostic device manufacturers, importers, distributors and EU Representatives.
This first day of the course introduces you to the key requirements of the IVDR. IVDs will now be classified according to their risk using a new rule-based system. The majority of IVDs will be subjected to independent assessment of their conformity to the Regulation by a Notified Body and will require third-party certification for the first time.
You will explore the four risk classifications and the conformity assessment routes for IVDs. It defines the Technical Documentation required, and the product safety and performance expectations, including requirements on clinical evidence, Post-Market Clinical Follow-up (PMCF) and Post-Market Surveillance (PMS). Traceability of devices through the supply chain and product labelling will be reviewed during the course.
The rest of the course aims to offer guidance on implementation of the requirements stipulated in the IVDR into your business. 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.
Please note: This course does not cover Medical Devices under the Medical Devices regulation (MDR EU2017/745).