"Variant Creutzfeldt-Jakob disease (vCJD) assays for blood screening, diagnosis and confirmation" has been added to List A of Annex II in the IVD Directive 98/79/EC.
For more information please see http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2011:341:0050:0051:EN:PDF
The Danish Ministry of Health has implemented the IVD Directive in BEK nr 494 af 12/05/2012: