Compliance Deadline for Meeting the Revised Medical Devices Directive - Will it be extended?
January 8th, 2010 | 
Author: As of March 21, 2010, device manufacturers must meet the revised guidelines for evaluation of clinical data, to continue selling products in Europe with a CE Mark. Most devices (Class III, Class II, Class IIA, and Class IA sterile) are subject to this requirement. Many manufacturers are meeting compliance by completing clinical literature reviews or conformity assessments. What is the likelihood the European Union will extend the deadline to allow more time for manufacturers and notified bodies to complete their assessments?
Posted in EU Directive
July 20th, 2010 7:48 am
Hello, i am an health professional practicing in germany and found your blogpost most interesting.