Market Surveillance & Vigilance Starting from the home page, a site dedicated to market surve

Market Surveillance & Vigilance

Starting from the home page, a site dedicated to market surveillance, vigilance and Eudamed, easily is accessible to manufacturers. The text reminds manufacturers that the enforcement of regulations is within the purview of each individual member state. To this end, National Competent Authority Reports (NCARs), aim to document certain adverse events, typically those that result in field safety corrective actions. Furthermore, NCARs are disseminated to other competent authorities, with a copy provided to the EU Commission. The ultimate goal of all these programs is to ensure patient and user safety throughout the European Union. These NCARs are linked from the Market Surveillance and Vigilance page, under the link to vigilance reports.

Details published within the NCARs include the country (member state) in which the incident occurred, dates of reception, the competent authority report reference number, and the local reference number. (Based on this information, it is feasible in some cases, to obtain details about these reports from an individual competent authority’s website.) There are reports that summarize the number of NCARs exchanged each year, as well as the competent authorities that made them available. Additionally, there are statistical analyses of the most recent completed year. Thus, the statistical analysis of NCARs reported in 2009 is, at present, the most current.

The NCAR information demonstrates that the competent authorities communicate with each other about vigilance and highlight the importance of vigilance and postmarket surveillance systems in the EU. Note that Eudamed was the subject of this column in this year’s June issue of Medical Product Outsourcing, and it is envisioned that it will be compulsory to exchange NCARs through Eudamed beginning May 1, 2011.