Requirements In Vitro Diagnostic Regulation 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).

 

On-demand - training that’s even more flexible

BSI’s on-demand courses are market-leading and available 24/7. Developed by top subject matter experts, they contain the same high-quality content you will find in our tutor-led training, but with the added benefit of being able to learn at your own pace and at any time.

How will I benefit?

This course will allow you to:

  • Identify the key requirements of the In Vitro Diagnostic Regulation
  • Interpret and communicate the key requirements and expectations of the IVDR to your organization
  • Identify the next steps in planning of product realization and commercialization in conformity with the IVDR