ADVERTISEMENT OF PKU CARDS in accordance with IVD regulation FOR STATENS SERUM INSTITUT/2025

1. Purpose Statens Serum Institut, hereafter ‘the contracting authority’, requests the performance of a task concerning PKU CARDS for Statens Serum Institut in accordance with Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in-vitro diagnostic medical devices, hereafter IVD regulation. The contracting authority hereby invites interested suitable companies to submit tenders for the performance of this task. The contracting authority’s suitability requirements and a description of which information and documents the companies shall submit in regard to the suitability assessment can be found in section 4.2 below and in the advertisement at www.udbud.dk. 1.1 General description of the purchase Statens Serum Institute (SSI) carries out screening of 25 serious congenital diseases in the national newborn screening program. All newborns in Denmark, Faroe Islands and Greenland are offered a heel prick test, where blood is spotted on a dried blood spot card (also called PKU card). The Danish PKU card consists of a filter-paper part for spotting the blood and a demographics part for information about mother and child. The Danish PKU card must be an IVD device and intended for use in newborn screening.