New rules on medical devices welcomed by cardiologists

21st June 2016

 

European cardiologists have welcomed plans for new rules on medical devices.

The new regulations are designed to allow patients to benefit from advanced technology sooner, while still insuring devices are safe.

The European Council said the regulations, which still need to be formally approved, will increase scrutiny of devices before they enter the market, enhance surveillance once they are being used, improve the availability of clinical data through a central database, and require devices to have unique identification numbers so they can be traced through the supply chain. The new rules will also contain time limits for various processes.

The regulations, due to cover all medical and in vitro diagnostic devices, have been agreed by the council and representatives of the European Parliament.

The European Society of Cardiologists (ESC), which represents around 95,000 cardiology specialists, says the rules will, for the first time, guarantee transparency for regulatory processes, and clinical information submitted by manufacturers will be made available to doctors and patients alike.

Professor Fausto Pinto, president of the ESC, said: “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."