Placing on the market

Placing on the market applies to each individual device, not to a device model, which matters when reading transition dates. It is the moment from which many manufacturer and importer obligations under the MDR and IVDR are counted.

‘placing on the market’ means the first making available of a device, other than an investigational device, on the Union market;

EU MDR, Article 2(28)

‘placing on the market’ means the first making available of a device, other than a device for performance study, on the Union market;

IVDR, Article 2(21)