EUROPEAN UNION CLASS III DEVICE APPROVALS AVERAGE 240 DAYS OR LESS, HIMA SURVEY SAYS; STUDY RELEASE INTENDED TO BOLSTER SUPPORT FOR FDA REFORM LEGISLATION
This article was originally published in The Gray Sheet
Executive Summary
Approval times for Class III devices covered by the Medical Devices Directive in the European Union are averaging 240 days or less, according to a study sponsored by the Health Industry Manufacturers Association.