Medical devices are designed and developed to improve patients’ lives. However it is sometimes forgotten that medical devices, as with all devices, have an inherent risk of failure or defect. While manufacturers try to foresee and minimize those risks they can never be fully excluded. Things can and will go wrong with medical devices. Vigilance deals exactly with these moments: a medical device fails or becomes defective and a patient or user gets or could have gotten seriously injured. The objective of vigilance is to minimize, to the best way possible, reoccurrence of events and as such ensuring the safety of patients and public health.
In this workshop we’ll go through the different vigilance reporting obligations and try to explain the importance of the information to be included in those forms which are submitted to a competent authority. A better insight in the work done by a competent authority’s vigilance team will give attendees a better understanding of the apparent trivial nature of frequently asked questions by such a team. As mentioned in the first paragraph, each and every single manufacturer of medical devices will at a point in time be in contact with a competent authority’s vigilance team. Understanding how this team tries to achieve the goal of ensuring patient’s safety could help you in the preparation of the vigilance reporting. And an effective communication will result in a more satisfying experience for both parties.
Learn more about Christophe Driesmans
Head of the Materiovigilance Entity, FAMHP