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IVDR - In Vitro Diagnostic Regulation

A Regulation to ensure safety and efficacy of in vitro diagnostic devices

Two new regulations were adopted in the EU for medical devices and in vitro diagnostic devices that aim to ensure better protection of public health and patient safety. One of those is the In Vitro Diagnostic Regulation (IVDR) that replaces the existing In Vitro Diagnostic Directive (IVDD). All manufacturers, authorized representatives, importers and distributors of IVDs in the EU, need to comply with these regulatory requirements. The number of IVD devices requiring Notified Body’s involvement increases from 7% under IVDD to around 80% under IVDR.

bioMérieux shares the ambitions of the IVDR. Indeed this regulation, by setting high standards of quality and safety, aims to guarantee the proper functioning of devices on the European market and to ensure a high level of health protection for patients and users.

 

The major changes introduced by IVDR compared to the previous IVDD

  • Increased involvement of Notified Bodies
  • New classification of IVD devices in 4 classes of risk:
    • Class A: low patient and public health risk.
    • Class B: Moderate individual risk and/or low public health risk.
    • Class C: High individual risk and/or Moderate public health risk.
    • Class D: High individual risk and high public health risk.
  • Demonstration of the Clinical Evidence of devices (based on Performance Evaluation Report)
  • More stringent Post Market Surveillance and Vigilance requirements
  • Clarification of obligations of economic operators (manufacturers, authorized representatives, importers and distributors)
  • Increased transparency with information being made public in a new European Database on Medical Devices (EUDAMED)

 

Timeline

All new devices (not CE Marked under IVD Directive before Date of Application) have to comply with IVDR from May 26th 2022.

The regulation (EU) 2024/1860 amends and extends the transitional provisions of existing devices compliant with IVDD according to their IVDR device classification as follows: 

Transitional Provisions for IVDD devices

bioMérieux and IVDR

In 2022, bioMérieux completed all its QMS IVDR Certifications & the CE Marking of Class A IVD Devices. In addition, our cross-functional teams are finalizing the IVDR Transition of our legacy IVD Devices (Class B, C and D).

We also launched multiple products directly under IVDR in the European Union, i-e since May 26, 2022.

bioMérieux is committed to supporting all our customers and distributors during this transition phase. By following this new regulation, we all together contribute to improve public health.

Contact

For more information, bioMérieux’s customers and distributors are invited to contact their usual contact partner or go to our Contact section.

Find out more about IVDR on euivdr.com.