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
IVDR Compliance status for bioMérieux: Shortly after IVDR designation of our Notified Body, our first IVDR Quality Management System audit took place in September 2021 after which we received our first IVDR EU Quality Management System certificates. This allows to starte CE mark our products under IVDR.
IVDR Compliance status for BioFire: We completed our first IVDR Quality Management System audit for BioFire products in March of 2021 and received bioMerieux's first IVDR certificate. In January of 2022, we officially CE marked the company's first products under IVDR (two instruments and two panels).
IVDR Compliance status for Astute: Our first IVDR Quality Management System audit took place in July 2021 with a very positive outcome. We expect to receive the official IVDR Quality Management System certificate and start to CE Mark under IVDR our first IVD devices very soon.
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.
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.