Aplikace systému Vigilance na zdravotnické prostředky z pohledu MDR 2017/745 a FDA

Abstract

The bachelor thesis deals with the creation of the procedure and the application of the Vigilance system to medical devices, both from the perspective of the new European standard MDR 2017/745 and the American system of medical devices regulation. The aim of the Vigilance system is to improve the protection of the health and the safety of patients, healthcare professionals and the other users by reducing probability of recurrence of adverse events related to the use of the medical device. There is precise description of the procedure to be followed by a medical device manufacturer after reporting an adverse event on the product. A complete documentation for the medical device manufacturer was created and then applied to a specific product for the company. All these documents are in accordance with legally binding laws and the European Union's recommended MEDDEV guidelines. The entire Vigilance system also includes the new extensive MDR 2017/745. Emphasis is also placed on the differences between the European and American system. The work includes forms to report an adverse event from the manufacturer to the FDA in USA as well as safety correction and notification forms.