title: Vigilance systems in the EU and the US:  a short comparison.
abstract: This article compares the approaches to vigilance systems taken in the European Union and the United States.  It details the type of information that must be collected following an adverse incident relating to the use of a medical device, and contrasts the time frames for reporting these details to the regulatory authorities. The differences highlight the need for standardization of the procedures, particularly when companies have to comply with both systems.
authors.affiliation: CellPro Europe, Wezembeek-Oppem, Belgium.
authors.forename: E
authors.initials: E
authors.lastname: van Eeckhoven
mesh_terms: D005062:European Union; D006801:Humans; D011358:Product Surveillance, Postmarketing / Q000379:methods*; D013997:Time Factors; D014481:United States; D014486:United States Food and Drug Administration