The differences of ‘intended use’ and ‘instructions for use’ in medical devices
In medical devices as well as in-vitro diagnostic devices the meanings and objectives of ‘’intended use/purpose’’ and ‘’instructions for use’’ are different:
- The ‘’intended purpose” of a device is a claim stated on the label for which the device was designed and determines for which medical purpose the device can be used, while
- ‘’Instructions for use’’ direct the user towards the appropriate use of the device.
Why does the differentiation between the two terms matter?
A) The ‘’intended purpose’’ also determines the class of the medical device. Moreover, the time in which the device achieves its intended purpose defines the appropriate classification rule of the medical device.
This is essential to establish which conformity assessment route the manufacturer needs to follow to ensure the compliance of his devices.
B) On the other hand, the leaflet with the ‘’instructions for use’’ includes all the data a user needs to receive in order to use a medical or IVD device without experiencing foreseeable negative side effects. The manufacturer needs to provide ‘’instructions for use’’ in a clear manner and in a language understood by the user.
Providing this information is a key legal requirement before placing a medical or IVD device on the EU market, although certain exceptions may be applied.
Manufacturers shall be aware that the new Regulation on Medical Devices will also be applicable to some devices without intended medical purpose, which might enlarge the scope of their obligations before placing such devices on the EU market.
To find out more about the EU Compliance process for your medical or in-vitro diagnostic devices and other changes introduced by the new Regulation, contact our team of experts. Obelis will gladly use its 30 years of experience to assist you!