Approval of Medical Devices

The Law Library of Congress is proud to present a new report, Approval of Medical Devices.

This report describes the approval process for medical devices in the European Union and fifteen countries, and also indicates whether or not an expedited approval procedure is available. In many nations, particularly those influenced by the EU, part of the review process is conducted not by the government but by private, independent organizations called "notified bodies." In most of the countries in the survey, medical devices are categorized based on the risks associated with their use, and the approval process varies by category.

Visit http://www.loc.gov/law/help/medical-devices/index.php to read the entire report and to view the accompanying map of jurisdictions with an expedited process for approval of medical devices.

This report is one of many prepared by the Law Library of Congress available at http://www.loc.gov/law/help/current-topics.php.