Fidest – Agenzia giornalistica/press agency

Quotidiano di informazione – Anno 32 n° 338

New EU Rules For Medical Devices Confirm ESC Position

Posted by fidest press agency su venerdì, 27 maggio 2016

sofia antipolisSophia Antipolis. 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.”

Rispondi

Inserisci i tuoi dati qui sotto o clicca su un'icona per effettuare l'accesso:

Logo di WordPress.com

Stai commentando usando il tuo account WordPress.com. Chiudi sessione /  Modifica )

Google photo

Stai commentando usando il tuo account Google. Chiudi sessione /  Modifica )

Foto Twitter

Stai commentando usando il tuo account Twitter. Chiudi sessione /  Modifica )

Foto di Facebook

Stai commentando usando il tuo account Facebook. Chiudi sessione /  Modifica )

Connessione a %s...

 
%d blogger hanno fatto clic su Mi Piace per questo: