IVDR - In Vitro Diagnostics Regulation
A new 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 IVDD
- Increased involvement of Notified Bodies
- New classification of IVD devices in 4 classes of risk:
- Class A: low patient and public health risks.
- 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)
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) 2022/112 amends and extends the transitional provisions of existing devices compliant with IVDD according to their IVDR device classification as follows:
While the roadmap is now very clear for existing products, the industry considers it is essential that regulators address the critical issues of bringing innovative solutions to the market and setting up the necessary infrastructure to obtain the new certification.
bioMérieux and IVDR
In 2022, bioMérieux completed all its QMS IVDR Certifications & the CE Marking of Class A IVD Devices. It is now on its way to full IVDR Compliance.
Our cross-functional teams continue to work on the progressive switch to IVDR of our legacy IVD Devices (Class B, C and D). Most of our devices will be IVDR Certified by the end of 2023.
We also launched our first new products under IVDR in the European Union, i-e after 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.