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Revision of Statutory Orders concerning Medical Devices and In Vitro Diagnostic Devices 23.11.2005
On 14 September 2005 the Danish Medicines Agency published the proposed revisions of the following two Statutory Orders for public consultation:
The proposed revisions are based on the fact that the Danish Medicines Agency takes over the role as Competent Authority for clinical trials of medical devices as regards the technical and medical assessment from the ethics committees. On this occasion the orders concerning medical devices have been revised now including definitions and rules for clinical trials of medical devices used on human beings. The date for implementation of the revised orders is 2006-01-01. Read more: http://www.medicinskudstyr.dk/1024/visNyhed.mu.asp?artikelID=6782
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