News International Newsletter

Value of regulatory reliance recognised in IMDRF White Paper 

Posted on 16.05.2024

The International Medical Device Regulators Forum (IMDRF) has recently published a White Paper on Regulatory Reliance. The paper draws from the conclusions of the joint IMDRF-DITTA-GMTA workshop that took place in Washington, DC, on 11 March 2024, at which MedTech Europe members presented. 

The paper highlights that reliance allows for knowledge sharing among regulatory authorities and reallocation of resources within a given regulatory authority without a decrease in regulatory requirements.  

Trust, communication, clarity and transparency among regulatory authorities relying on one another were identified as the key elements for a successful implementation of reliance models. Moving forward, the IMDRF is expected to play an increasingly critical role in bringing stakeholders together to share experiences and build trust. 

For more information, please contact Dario Belluomini, Manager International Affairs.