Sophia Antipolis, 26 May 2016: On 25 May 2016, EU policymakers agreed to new rules on medical devices and invitro diagnostic medical devices.
This political agreement is still subject to the approval of the Council's Permanent Representatives Committee and the Parliament's ENVI Committee.
Prof. Fausto Pinto, President of the European Society of Cardiology said:
The ESC welcomes this agreement and looks forward to engaging with regulatory authorities and HTA bodies in promoting excellence in patient management.
Prof. Alan Fraser, Chairman of the ESC Medical Devices Committee said:
The new rules will, for the first time, guarantee transparency for the regulatory process in Europe, where clinical information submitted by manufacturers will be made available to clinicians and patients alike.
This legislation, once passed, will herald a new era for active engagement by scientific, engineering, and clinical experts in writing specific standards for the clinical evaluation of medical devices, and in contributing to improved monitoring of their performance.