Requirements of the In Vitro Diagnostic Regulation (IVDR) Training Course
The In Vitro Diagnostic Regulation details the requirements which manufacturers have to meet to sell In Vitro Diagnostic devices in the European Union. It replaces the In Vitro Diagnostic Directive.
This 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.
The course explores 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.
Please note: This course does not cover Medical Devices under the Medical Devices regulation (MDR EU2017/745).
Spring discount: double combination discount
BSI usually offers a combination discount when you combine several training courses within a learning path. Are you registering for multiple training courses in May 2020? Then we offer a double combination discount. This offer applies to both the classroom training courses and our online training courses from Connected Learning Live. Register here >
Online training courses: Connected Learning Live
You can attend this training course classroom based and online. Do you prefer the convenience of an online training course? View here for the available dates or read more about Connected Learning Live.