Danish order concerning in vitro diagnostic medical devices
21.02.2000
As No. 2 in Europe (after Sweden) Denmark now transposes the IVD Directive into Danish law in the form of order No. 89 of 4 February 2000 from the Ministry of Health.
The transposition of the IVD Directive is published in the National Gazette (Lovtidende) on 15 February 2000. The new order causes modifications to order No. 734 of 10 August 1994 (Directive 93/42/EEC) concerning medical devices. These modifications will at the same occasion be published in order No. 92 of 7 February 2000 about medical devices.
- DGM expects that the issue of the Danish order within the IVD field will prepare the way for DGM's application for authorization to perform approvals in accordance with the IVD Directive now being finalized and we look forward to serving clients working within the IVD field in Denmark and abroad, says Poul Schmidt-Andersen, Director at DGM.
DGM's future role as Notified Body within the IVD field will primarily be based on the competence of 2 of DGM's 6 founders, namely Copenhagen University Hospital and Statens Serum Institut. The 2 founders contribute with their expertise within, among other areas, blood group determination and virology.
Further information:
Director Poul Schmidt-Andersen, DGM, +45 39 96 64 00.
