IVDR Support and Transition
European laboratories and healthcare providers will be presented with a unique set of challenges as the new European regulations for diagnostic devices are fully implemented. Although EU Regulation 2017/746 on in vitro diagnostic medical devices (IVDR) came into force in 2017, it included a five-year transition period that ends in May of 2022. This transition period was intended to give manufacturers time to prepare and ensure a smooth transition to the new regulations. However, at the end of 2021, the transition periods for products requiring review by a notified body were extended.
Minimizing Interruptions for Your Laboratory
As full IVDR implementation occurs, you can be confident in the Promega products your laboratory uses. The five-year transition period allowed us to expand resources around our IVD portfolio to ensure that the products that fall within scope of IVDR will be ready when your laboratory needs them.
What is IVDR?
Replacing the 20-year-old In-vitro Diagnostic Directive (IVDD), the new IVD regulation includes requirements intended to improve quality standards, product safety and regulatory transparency. It provides comprehensive coverage of all IVD medical devices, including those using complex new technologies that were introduced after IVDD as well as point-of-care and companion diagnostics. These changes will ensure that laboratories are working with high-caliber instruments and reagents, improving the quality and reliability of results, which ultimately benefits patients.
Benefits of IVDR include:
- Higher standards of quality and safety for IVD medical devices
- New risk classification system that aligns with international guidance
- Stronger oversight and traceability across the supply chain and throughout the device lifecycle
- New clinical evidence requirements
- Improved transparency through the new comprehensive EU database on medical devices (EUDAMED)
- Better ability to accommodate new technologies and scientific advances in the future
How We Have Prepared
IVDR is a positive step forward for healthcare and patients, but a successful transition to a new regulation takes time and planning. Following the announcement in 2017, we began preparing our Quality Management System and CE-marked IVD products for compliance with the new regulations. We worked diligently to include IVDR requirements in all of our relevant processes and product documentation to ensure that both our existing CE-marked IVD products and new ones currently in development will be IVDR compliant at the end of the transition period.
External Resources
More information about the New EU regulations can be found in these resources.
