CE Marked Blood Grouping Reagents, are available as a distinct range of products from Rapid Labs to meet the demands of our clients that require a Free Sale Certificate and or a CE Certificate as specified by their own regional registration system or for supply into the European Union Markets.
CE Marked Blood Grouping Reagents for ABOD fall into one of the most highly regulated classes of diagnostic reagents, currently the regulations concerning their production fall under the EU IVD Directive, this is being replaced by the IVDR with final implementation having approximately 4 years before it is fully implemented.
The cost to comply with this most stringent regulation is high due to the high level of notified body involvement from the Product file assessment to the annual audits, unscheduled audits and batch/lot release testing and supervision. As a result the selling price of the CE Mark reagent is higher than the Non CE Mark equivalent.
Due to the Batch Release process and the cost for this, there is currently a minimum order level, below which it is not cost effective to produce. Please consider a minimum order of 500 vials per type for the CE Marked product.