Hi Nancy Regarding the reports of problems associated with it (eg reported by the manufacturer or by healthcare professionals), for the UK the Medicines, Healthcare Products and Regulatory Agency (MHRA) are the responsible agency:
<<http://www.mhra.gov.uk/Publications/Safetywarnings/MedicalDeviceAlerts/index.htm>> For the EU, the list of agencies who have to distribute safety notifications is linked from here: <<http://ec.europa.eu/enterprise/medical_devices/meddev/meddev_en.htm>> (Section 2.12 "List of contact points") "Vigilance reports" are listed here, although no specific details are provided - you'll need to search the appropriate country's agency websites. Googling the UK references does take you back to the relevant safety alerts page. <<http://ec.europa.eu/enterprise/medical_devices/ca/notif_report.htm>> You could also make a FOI request to the MHRA for any problems reported with the medical device - you can do so here: <<http://www.whatdotheyknow.com/body/mhra>> Hope this helps Alex 2009/10/14 Nancy Watzman <[email protected]>: > Hi, > > I'm new to this list. I work for the Sunlight Foundation, and Micah Sifry > suggested that folks here might be able to help me with some information I'm > looking for. For an investigation on transparency of health information, > I've been tracking an example of a particular medical device manufactered by > a U.S. company. The company has marketed this device in Europe since 2005; > however, it does not do so in the U.S. because it has not received approval > by the Food and Drug Administration. > > I'm wondering if there's some way to track how this device has been marketed > in Europe, in particular whether there have been any reports of problems > associated with it. It would also be helpful to know how widely it's > marketed. In the U.S. the source of much of this information would be the > FDA, but I don't know what the equivalent would be for the EU. > > Any advice or tips would be much appreciated. > > Thanks, > > Nancy Watzman > > -- > Nancy Watzman > consultant > Sunlight Foundation > > 2349 Dexter Street > Denver, CO 80207 > > 303.329.8563 (voice) > 303.514.0888 (cell) > > > _______________________________________________ > Mailing list [email protected] > Archive, settings, or unsubscribe: > https://secure.mysociety.org/admin/lists/mailman/listinfo/developers-public > _______________________________________________ Mailing list [email protected] Archive, settings, or unsubscribe: https://secure.mysociety.org/admin/lists/mailman/listinfo/developers-public
