Since the publication of EU MEDDEV 2.12-1, there should be no surprise that the vigilance requirements in the new EU MDR share a lot of similarities. However, there are a few important changes, not really new, but rather bringing the EU legislation up to date. Although the May 2020 date has been postponed a year, this doesn’t mean you have more time to wait. Medical device manufacturers need to ensure that their procedures are updated NOW and employees responsible for vigilance reporting are trained on all the changes.
Hosted by MedTech Intelligence, with guest speaker Michele Donatich will educate you on what you need to know about the definitions, terminology, reporting timeframes and other changes for assuring compliance with EU-MDR/IVDR vigilance regulations.