Norwegen – Medizinische Geräte – Copy of PCR instrument

Equipment for PCR analyses with instrument specific consumables for The Regional Health Authority Nord-Trøndelag. The contracting authority will find that the equipment/analyses go under risk class C cf. EUR-Lex - 02017R0745-20250110 - EN - EUR-Lex (Annex VIII Classification Rules) and mdcg_2020-16 fox 5 Classification Guidance. Thus, transitional arrangements for medical equipment - the Directorate of Medical Products stating that the offered analyses/kits shall fulfil the requirements for IVDR by 31.12.2028 for equipment/analyses in risk class C.