EU 2017/745 Regulation has replaced Medical Devices Directive 93/42/EEC and Active Implantable Medical Devices Directive 90/385/EEC. The new regulation ensures the movement of medical devices with safety in the EU market. It also contains new guidelines regarding Information for Use (IFU) for medical devices. The importance of “Information for Use” is evident in the medical device manufacturing industry. Providing adequate instructions of use enables medical device users to use these devices safely and efficiently.
According to EU MDR, medical device manufacturers should include the following in IFU:
The IFU must include the trade name of the medical device.
IFU must include the registered trademark and address of the manufacturer.
IFU must have its Date of Issue or revision dates written with them. They must also contain information on where to find the latest version or revision of IFU.
If present, the IFU must contain information regarding the inclusion of
IFU must contain the indication of the device’s sterile state and the sterilization method used for sterilization.
Instructions for sterilization applicable to medical devices that are supplied non-sterile and must be sterilized before their use.
The IFU will mention the overall qualitative composition and quantitative information regarding the main constituent(s) to achieve the principal intended action. This must be done for the devices which constitute of:
IFU must contain information regarding the intended purpose. This must also contain:
IFU must mention information regarding training and qualification requirements. It must also state information about:
IFU must contain information in storing and handling the medical device.
IFU should have the information that is required for verification of proper installation of the medical device. The information must also mention that the device is ready to be used as intended. Where relevant, this information must state:
IFU should mention the information regarding preparatory treatments as well as handling of the device. These preparatory treatments or handling methods must be considered before the device is made ready for use. they can also be considered during the device’s use (e.g., sterilization, calibration, final assembly, etc.).
IFU can also include any expected clinical benefits of the device.
IFU should mention the performance characteristics of the medical device.
IFU will show any specification which the user needs for the appropriate use of a medical device.
IFU must show the information regarding the risks associated with the reuse of those devices which are intended for single use only.
For those medical devices intended to be used with other devices and/or some general-purpose equipment, IFU will identify those devices and equipment. This will allow their safe use. Also, any known restrictions present to the combination of devices and equipment must be mentioned.
Overall qualitative and quantitative information regarding the materials and substances used to make implantable devices and how patients can get exposed shall be present on the IFU.
IFU of implanted devices shall contain the following information:
o Reciprocal interference
o Medical examinations
o Environmental conditions
IFU will contain detailed information regarding the medical device’s safe disposal and its accessories and consumables.
If the device is intended to be used by laypersons, its IFU will describe its consultation with a healthcare professional.
Products that do not have an intended medical purpose, such as contact lenses and liposuction equipment, will have the IFU containing information regarding the absence of their clinical benefit and risks related to their use.
In case any patient/user faces a serious incident, IFU will display a notice which will tell them to report the incident to
For IFU of those devices that incorporate electronic programmable systems such as software or the devices that are software themselves, minimum requirements that will concern their
For IFU of those devices that emit radiation for medical purposes, detailed information will be given regarding their:
It will also contain information regarding the protection of
The information for reusable medical devices must contain information on
If a reusable medical device is sold and used in a specific country, the IFU must show the validated re-sterilization method determined by that country. If a reusable device has attained a maximum number of signs of degradation that allowed for reuse, it must be mentioned that the device is not usable anymore.
IFU will show any
I will show all the relevant warnings and precautions when substances will be intended for their use within the human body.
The following information given in the IFU will be conveyed to the patient:
IFU shall show any
IFU must show
The following requirements should be mentioned on IFU only if they are applicable:
IFU must contain information about substances that are subjected to label requirements according to Section 10.4.5 of EU MDR.
IFU must contain a statement if the device is intended for single use.
IFU must contain instructions if sterile packaging of the device is opened or damaged before its usage.
According to Article 32 of EU MDR, the IFU must contain links to safety and clinical performance.
The IFU will show a healthcare professional’s permission who has verified the medical device’s suitability for work.
The IFU will show a healthcare professional’s permission who has verified the correct corresponding software and accessories to be used with the medical device.
IFU will show a statement that says that a device can be reused if the manufacturer reconditions it under his responsibility.
At Alysidia, our professionals’ team helps medical device manufacturers all across Europe comply with EU MDR’s requirements. If you are a Medical Device Manufacturer in Europe looking for quality electronic IFUs for your medical devices, contact us to become an MDR compliant medical device manufacturer having the advantage of electronic IFUs in Europe.
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