The new European regulatory framework for medical devices: opportunities for engagement by electrophysiologists †

Since 2010, the European Society of Cardiology (ESC) has engaged with policymakers to advocate appropriate legislation and regulations to guarantee that European patients can have timely access to medical devices that are safe and effective.1 Finally, on 5 May 2017, two new European Union (EU) laws were published, concerning medical devices2 andin vitro diagnostic medical devices. These regulations replace EU directives from the 1990s, which had become outdated due to the rapid pace of technological advances and changing patterns of medical practice. From 2020, they will govern all aspects of the life cycle of medical devices from initial market approval to post-market surveillance.
Source: Europace - Category: Cardiology Source Type: research