Putting into service

Putting into service matters for devices that never pass through the market in the usual way, such as in-house devices made and used within health institutions. For most devices it follows placing on the market, and both terms mark when EU obligations start.

‘putting into service’ means the stage at which a device, other than an investigational device, has been made available to the final user as being ready for use on the Union market for the first time for its intended purpose;

EU MDR, Article 2(29)

‘putting into service’ means the stage at which a device, other than a device for performance study, has been made available to the final user as being ready for use on the Union market for the first time for its intended purpose;

IVDR, Article 2(22)