The European Medical Device Regulation (EU MDR) regulates the way medical devices are placed on the market, made available on the market or placed into service. It improves transparency and ensures the safety and performance, including clinical benefits, of the device when used as intended by the manufacturer.
LivaNova is leading a vast effort to provide clinical continuity by making its proven solutions available under the new regulation. Thousands of products will be transitioned to MDR, many of which have already been transitioned.
Unique Opportunity to Increase Focus on Patient Outcomes
Safety for Patients & Users
The transition to the new regulation allows us to maintain high standards of product documentation and update our line to state-of-the-art safety requirements.
Product Continuity
A full team of LivaNova experts is working on securing our product line to minimize impact on patients and users.
Portfolio Relevance
MDR provides us with the opportunity to review our portfolio and ensure our offering remains relevant for the needs of patients and clinicians.LivaNova’s MDR Product Details
For any additional information, please contact your LivaNova sales representative.
Perfusion Tubing Systems
More than 4,000 customized Perfusion Tubing Systems will be transitioned to MDR! LivaNova will continue to provide customized PTS to match patient tailored treatments and perfusionists’ clinical needs.
1000+ Sterile Stand-Alone Products
More than 1000 Sterile Stand-Alone Product codes will be transitioned under the MDR.
DEHP-Free Catalogue
A renewed full PVC tubing catalogue without DEHP will be available for the perfusionist.
