Norway · Buyer: SYKEHUSINNKJØP HFKopi avPCR instrument
Description
Utstyr for PCR-analyser med instrumentspesifikt forbruksmateriell til Helse Nord-Trøndelag HF. Oppdragsgiver finner at utstyret/analysene går inn under risikoklasse C jfr. EUR-Lex - 02017R0745-20250110 - EN - EUR-Lex (Annex VIII Classification Rules) og mdcg_2020-16 rev 5 Classification Guidance. Dermed gjelder Overgangsordninger for medisinsk utstyr - Direktoratet for medisinske produkter som sier at tilbudte analyser/kit skal oppfylle krav til IVDR innen 31.12.2028 for utstyr/analyser i risikoklasse C.
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