Making available on the market

Every handover along the supply chain counts, from manufacturer to distributor to hospital, whether paid or free. The first such supply is 'placing on the market', and distributors and importers carry obligations each time they make a device available.

‘making available on the market’ means any supply of a device, other than an investigational device, for distribution, consumption or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge;

EU MDR, Article 2(27)

‘making available on the market’ means any supply of a device, other than a device for performance study, for distribution, consumption or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge;

IVDR, Article 2(20)