After several high-profile scandals surrounding medical devices, where irresponsible manufacturers’ malpractice in cutting corners showed how easy it was to abuse the Directive, the IVDR came ...

IVDs are defined in the new EU IVDR legislation as: “Any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, piece of equipment ...

MRC Holland recently announced that five SALSA MLPA assays for the detection of hereditary breast and ovarian cancer (HBOC) ...