If a product is manufactured by a non-MDA registered laboratory and then supplied to a MDA registered laboratory who supplies the industry; would this appliance conform?
Placing on the market is defined in the Regulations as the first making available in return for payment or free of charge of a new device, with a view to distribution, use or both on the Community market. In this instance the device is not being placed on the market when it is supplied by the first laboratory and they would be considered to be a sub-contractor to the second laboratory. The second laboratory would be responsible for ensuring compliance compliance with the regulations because they are placing the device on the market in their own name. The definition of a manufacturer in the regulations is the person responsible for placing the device on the market in their own name regardless of whether they actually make the device themselves.
