Manufacturers and EU importers of medical devices are periodically confronted with new sets of rules imposing new product conformity requirements. Apart from MDR/IVDR, other EU legislation as well as revisions of ISO standards may compel companies to secure future marketability of legacy products on stock before the expiry of transition periods. To take advantage of transition mechanisms, EU legislators regularly require that affected products have to be “placed on the market” prior to a cut-off date. But what does that mean, and how should companies practically implement and record a “placing on the market”?
