Ireland's competent authority initiatives.
Ireland is one of the countries in the European Union, that have transposed both directives on medical devices into national legislation. A detailed discussion on issues regarding the transposition of the directives, the implementation of the vigilance system, the registration requirements in Ireland as well as the Department's view in current developments, particularly the potential use of EDI for the information exchange between all Competent Authorities, is presented in this paper.
Scully
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Department of Health, IRL-Dublin, Ireland.
D004864:Equipment and Supplies / Q000592:standards; D017408:Guidelines as Topic; D007256:Information Systems; D007494:Ireland; D007883:Legislation, Medical; D011358:Product Surveillance, Postmarketing / Q000379:methods / Q000592:standards; D012042:Registries