May 18, 2011

The European Society of Cardiology (ESC) has published a position paper in the European Heart Journal arguing for the establishment of a single European regulatory system overseeing evaluations and approvals of medical devices.

The paper was issued following an ESC conference held earlier this year pushing for greater influence of medical experts in devising medical device policy in the EU.

The ESC paper calls for a single coordinated regulatory system in order to best integrate processes between European competent authorities. Such a move would enable those authorities to uniformly and consistently apply standards.

Reorganization of notified bodies into an integrated structure is also in order, argues the ESC. In such a reorganization, regulators would direct device applications to appropriate notified bodies; those bodies would either retain their decentralized status within an integrated system or form the technical unit of a new EU medical devices agency. Widespread assumptions that CE Marking indicates clinical effectiveness furthermore require a review of the CE Mark’s meaning, according to the ESC.

In addition, the group advocates setting up product standards for each Class II and Class III category of medical devices. Medical experts would recommend specific standards for particular devices’ clinical performance and effectiveness.

The ESC paper also argues for disclosure of devices’ technical information by manufacturers to physicians, as well as establishing a comprehensive registry of devices.


  • Stewart Eisenhart