After a few quiet years, several important European regulatory changes have occurred that will affect most medical device manufacturers. Most notably, Competent Authorities are now expecting manufacturers to have a good understanding of post-market surveillance, including vigilance. Notified Bodies and Competent Authorities alike are starting to make this a key element of their inspections and companies must be prepared.
In this presentation, Dr. Loh discusses important new revisions to MEDDEV 2.12-1 rev 5, Guidelines on a medical devices vigilance system, published in April 2007. The guidelines entered into force on January 1st, 2008.
Industry Update: Vigilance for Medical Devices was presented on 2007-06-21 and is available to download to www.fxconferences.com
