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.
Information to be added in IFU According to EU MDR
According to EU MDR, medical device manufacturers should include the following in IFU:
Trade Name
The IFU must include the trade name of the medical device.
Registered Trademark & Address
IFU must include the registered trademark and address of the manufacturer.
Information Regarding Important Dates Related to Medical Devices
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.
Information Regarding an Incorporated Substance in the Medical Device
If present, the IFU must contain information regarding the inclusion of
- A medicinal substance (e.g., human blood or plasma derivative)
- Tissue or cells or their derivatives of human origin;
- Tissue or cells or their derivatives of animal origin.
State of Sterility of Medical Device
IFU must contain the indication of the device’s sterile state and the sterilization method used for sterilization.
Instructions for Sterilization
Instructions for sterilization applicable to medical devices that are supplied non-sterile and must be sterilized before their use.
Qualitative and Quantitative Information for Specified Devices
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:
- Substances that must enter the body through a body orifice
- Applied to skin
- Absorbed by the body, or
- Locally dispersed by the body.
Information Regarding Intended Purpose
IFU must contain information regarding the intended purpose. This must also contain:
- Any contra-indications;
- Specification of indications;
- Patient target group(s), and
- Information regarding the intended user(s).
Information Regarding Training & Qualification Requirements
IFU must mention information regarding training and qualification requirements. It must also state information about:
- Device user, and
- Information regarding other facilities.
Information Regarding Storage & Handling
IFU must contain information in storing and handling the medical device.
Information Regarding Correct Installation and Use of 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:
- Maintenance instructions;
- Cleaning or disinfection of the device;
- Replacement of consumables;
- Calibration, and
- Instructions on risk elimination
Information on Preparatory Treatments & Device Handling
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.).
Expected Clinical Benefits
IFU can also include any expected clinical benefits of the device.
Performance Characteristics
IFU should mention the performance characteristics of the medical device.
Specifications for the User Regarding Appropriate Use of Medical Device
IFU will show any specification which the user needs for the appropriate use of a medical device.
Risks Associated with Re-use of Devices Intended for Single-Use
IFU must show the information regarding the risks associated with the reuse of those devices which are intended for single use only.
Medical Devices intended to be used with Other Devices or General Purpose Equipment
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.
IFU for Implantable Devices
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 for Implanted Devices:
IFU of implanted devices shall contain the following information:
- Identification of device (name and serial number etc.);
- Expected lifetime;
- Any other information to ensure the safe use of the device, and
- Warnings and precautions regarding
o Reciprocal interference
o Medical examinations
o Environmental conditions
Information Regarding Safe Disposal of the Medical Device
IFU will contain detailed information regarding the medical device’s safe disposal and its accessories and consumables.
Professional Consultation for Medical Device
If the device is intended to be used by laypersons, its IFU will describe its consultation with a healthcare professional.
Information Regarding Products without an Intended Medical Purpose
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.
Reporting of Incident to Manufacturer & Competent Authority
In case any patient/user faces a serious incident, IFU will display a notice which will tell them to report the incident to
- the manufacturer of the device, and
- the Competent Authority of the country where the user/patient resides.
IFU for Devices Incorporating Electronic Programmable Systems
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
- Hardware;
- Characteristics of IT network, and
- IT security measures that are necessary to run that software as intended will be given.
Information for Radiation Emitting Devices
For IFU of those devices that emit radiation for medical purposes, detailed information will be given regarding their:
- Nature;
- Type;
- Intensity, and
- Distribution of the emitted radiation.
It will also contain information regarding the protection of
- Users
- Patients
- Persons.
Information for Reusable Devices
The information for reusable medical devices must contain information on
- Cleaning processes
- Disinfection
- Packaging
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.
Relevant Warnings Regarding Medical Device
Relevant Warnings Regarding Device’s Use
IFU will show any
- Warnings
- Limitations
- Precautions
- Contra-indications
- Measures to be taken regarding device’s use.
Relevant Warnings Regarding Substances to be Used Within Human Body
I will show all the relevant warnings and precautions when substances will be intended for their use within the human body.
Information to be conveyed to the Patient
The following information given in the IFU will be conveyed to the patient:
Information Containing Details of Risks Associated with the Device
IFU shall show any
- Risks;
- Contra-indications, and
- Any undesirable side-effects that are associated with the device.
Information Regarding Warnings & Precautions
IFU must show
- Any residual risks;
- Contra-indications, and
- Any undesirable side-effects.
Applicable Requirements for IFU under EU MDR
The following requirements should be mentioned on IFU only if they are applicable:
Information Subjected to Label Requirements
IFU must contain information about substances that are subjected to label requirements according to Section 10.4.5 of EU MDR.
Statement Regarding Use of Device
IFU must contain a statement if the device is intended for single use.
Instruction for Damaged Sterile Packaging
IFU must contain instructions if sterile packaging of the device is opened or damaged before its usage.
Links to Summary of Safety & Clinical Performance-Article 32
According to Article 32 of EU MDR, the IFU must contain links to safety and clinical performance.
Allowance of a Healthcare Professional Regarding Device’s Suitability
The IFU will show a healthcare professional’s permission who has verified the medical device’s suitability for work.
Allowance of a Healthcare Professional Regarding Software & Accessories
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.
Reuse of Medical Device
IFU will show a statement that says that a device can be reused if the manufacturer reconditions it under his responsibility.
An Electronic IFU for your Medical Device
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. Contact Us or send us an email at info@alysidia.com
