Essentials of European Medical Device Regulatory Affairs

Instructions for the User (IFU)

• Most of label information is repeated on IFU • Undesirable side-effects • Information on use with other devices or equipment • Installation, operation, maintenance and calibration information • Where appropriate, risks to avoid with implantation of the device or the reciprocal interference posed by the presence of the device during specific investigations or treatments • Sterile packaging damage statement and where appropriate instructions for re- sterilization • Risks if a single use product is reused • Where applicable, instructions for re-use, cleaning or sterilization • Details of further treatment or handling needed before the device can be used • For devices emitting radiation, details • Date of issue or revision of IFU

The Organisationfor Professionals inRegulatory Affairs

IFU continued

To allow medical staff to brief patients on contra-indications and precautions the following details should be included:

• Precautions in the event of change in performance • Precautions re exposure to magnetic fields, external electrostatic discharge, pressure or variations in pressure etc. • Adequate information regarding the medicinal product(s) which the device may administer, including limitations in the choice of substances to be delivered • Precautions for special, unusual risks relating to disposal • If appropriate, medicinal substance(s) incorporated into device • The degree of accuracy claimed for devices with measuring function

The Organisationfor Professionals inRegulatory Affairs