eIFU — Electronic instructions for use

Instructions supplied in non-paper form rather than on paper. Permitted only to the extent and under the conditions set by the regulation and the Commission implementing regulation on electronic instructions for use, which restricts which devices qualify and requires paper copies to remain available on request.

Reference: MDR Annex I Section 23.1(f)

Implant card

The card supplied with an implantable device carrying the information needed to identify it, including name, serial or lot number and UDI, together with warnings and precautions. The health institution makes it available to the patient.

Reference: MDR Article 18

Instructions for use

The information provided by the manufacturer to inform the user of a device's intended purpose and proper use and of any precautions to be taken.

Reference: MDR Article 2(14); IVDR Article 2(14)

Label

The written, printed or graphic information appearing either on the device itself, or on the packaging of each unit or on the packaging of multiple devices.

Reference: MDR Article 2(13); IVDR Article 2(13)