IVDR: Insights of the Regulation (EU IVDR (2017/746))

The IVDR (In-Vitro Diagnostic Regulation) is a new set of regulations set forth by the European Union (EU) in 2017 to regulate medical devices and in-vitro diagnostic devices. The purpose of the IVDR is to improve patient safety by ensuring that all medical devices, including in-vitro diagnostic devices, are designed, manufactured, and marketed to meet the highest safety and quality standards.

Read this White Paper to Understand the Challenges of the IVDR:

1. The biggest challenge facing the medical device and in-vitro diagnostic industries is the transition to the new IVDR requirements.
2. The IVDR requires all medical devices, including in-vitro diagnostic devices, to be reclassified, re-evaluated, and re-certified. This can be a time-consuming and expensive process for manufacturers.
3. The IVDR introduces new requirements for clinical evaluations and performance studies, which can be challenging for some manufacturers, especially small and medium-sized enterprises (SMEs).
4. The IVDR requires manufacturers to establish and maintain a robust post-market surveillance system, which can be difficult for some companies, particularly those with limited resources.

Journey of IVDR:

1. The IVDR requires all medical devices, including in-vitro diagnostic devices, to be classified into four classes, based on their level of risk.
2. Manufacturers must comply with the IVDR requirements by following a comprehensive and rigorous assessment process, including clinical evaluations and performance studies.
3. The IVDR requires that all in-vitro diagnostic devices must be CE marked, indicating that they meet the essential requirements of the regulation.
4. The IVDR establishes a new EU-wide system for the vigilance and market surveillance of medical devices, including in-vitro diagnostic devices, to ensure their ongoing safety and performance.