Labelling and instructions for use (IFU)

What is meant with “labelling” and “instructions for use (IFU)”?

According to the European Medical Device Regulation (MDR), ‘label’ means 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. In addition, the ‘instructions for use’ means 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. MDR annex I, section 23 list the general requirements that you as a manufacturer must follow in the context of label and IFU.

AML Christensen’s service
At AML Christensen, we have a long-lasting experience in developing IFUs that comply with the requirements of the EU MDR and relevant guidelines. We will be happy to help you develop an MDR-compliant IFU or revise your existing labelling and IFU.