The IVDR Cake. We’ve got a slice!

By April 14, 2022


Sweeping changes to the medical device industry in the European Union (EU) are amongst us. The EU In Vitro Diagnostic Medical Device Regulation (IVDR) (EU) 2017/746 will come into force on May 26, 2022 – replacing the EU In Vitro Diagnostics Directive (IVDD) 98/79/EC. Healthcare Providers and medical device manufacturers alike are working diligently to ensure that their services and products are compliant with these new regulations. In particular, clinical laboratories will be required to justify the use of in-house laboratory developed tests (LDTs) when an equivalent regulated device is available, and labs must also re-validate their LDTs to ensure conformity with these new regulations. This is causing some lab leaders to evaluate which LDTs they can continue to reasonably offer. (Ceglarek, 2021)

The Opportunity for Customized Systems

Waters is not immune to the impact of the IVDR and is fully committed to providing its customers with liquid chromatography-mass spectrometry (LC-MS) systems that are compliant with these new regulations. Our enterprise-wide team has ensured that its MassTrak™ IVD portfolio of LC-MS products meets the IVDR requirements for labeling, product classification, clinical evidence, and quality management systems. Our approach provides customers with the flexibility to customize their LC system and select one of three tiered MS offerings. In effect, Waters continues to shape the future of how it designs, manufactures, and registers its IVD products to best meet customer needs.

Our enterprise-wide team has ensured that its MassTrak IVD portfolio of LC-MS products meets the IVDR requirements for labeling, product classification, clinical evidence, and quality management systems.

 

Meeting Demand for Continuous Service and Flexibility

In accordance with the EU IVDR, the following Waters MassTrak IVD system solutions include:

  • ACQUITY UPLC I-Class PLUS / Xevo TQD IVD System
  • ACQUITY UPLC I-Class PLUS / Xevo TQ-S micro IVD System
  • ACQUITY UPLC I-Class PLUS / Xevo TQ-XS IVD System
  • RenataDx Screening System

In addition, MassLynx 4.2 IVD, TargetLynx XS IVD, IonLynx IVD, and certain ACQUITY UPLC Columns will also conform to the new regulations. Having a tiered system approach – stratified principally on analytical sensitivity – gives clinical laboratories the flexibility to choose the LC-MS system that best meets their needs.

We are working hard to empower the biomedical research community by developing LC-MS/MS-based solutions that are both powerful and easy-to-use.

Clinical laboratories have enough on their plate now when faced with conforming to these new regulations. Waters is committed to helping its customers ensure the continuity of the valuable diagnostic services they provide to their patients. Concerns about their LC-MS manufacturer’s conformity with these new, more stringent regulations should take one more thing off their plate. May I suggest perhaps a delicious slice of that cake?

 

 

Find out all about Waters IVDR Resources

References

Ceglarek, U. (2021, December 02). Newborn screening: early detection – new diagnostic possibilities. Retrieved from healthcare-in-europe.com

Additional Resources

Webinar: Update on the latest changes to the IVDR application and implications for Lab Developed Tests – Held February 17, available on demand

Blog: The Future Generation of  LC-MS/MS-IVD Solutions

Blog: Embracing Analytical Techniques Into Regulated Laboratories

Blog: Comprehending COVID-19: How Consumables Can Increase LC-MS/MS Sensitivity