Instructions for Use and Medical Devices
CE marking on medical devices indicates that they comply with the applicable European legislation with regard to product safety. Part of the CE marking process is drafting the Instruction For Use (Hereafter: IFU). The IFU provides general information on the use of the medical device as well as safety information including warnings.
The Medical Devices Regulation (EU) 2017/745 (hereafter: MDR) states that an exception is made for class I and class IIa medical devices. This means that an IFU is not required for the aforementioned classes if the devices can be used safely without any instructions. However, if the devices require specific instructions on a comprehensive cleaning procedure, sterilization procedure or information how and when to re-use the device, an IFU is required.
What information must the IFU entail?
In accordance with the MDR the IFU shall contain the following information:
- The (trade) name of the device.
- The name and address of the manufacturer.
- If applicable, an indication that the device contains or incorporates medicinal substances or tissues or cells from human origin or animal origin.
- Information regarding storage and handling conditions.
- If the device is supplied in a sterile state, an indication of its sterile state and sterilization method.
- If the device is intended for single use, an indication of that fact.
- If device is applicable for in vivo use, information on the in vivo use.
- The intended purpose of the device as well as the intended users and patient groups.
- Where applicable, the expected clinical benefits.
- The performance characteristics of the device.
- Where applicable, suitable information for the healthcare professional to work with the device.
- Any residual risks etc. to be conveyed to the patient.
- Specifications that the user requires to use the device appropriately.
- Details of any preparatory handling of the device before it is ready for use or during its use, e.g. sterilization or calibration.
- Any requirements for special training.
- Information to verify whether the device is properly installed.
- If the device is supplied in a sterile state, instructions when the packaging is damaged or unintentionally opened.
- If the device is intended to be sterilized before use, instructions for the sterilization.
- If the device is reusable, information for allowing reuse.
- If appropriate, an indication that the device can only be reused if it is reconditioned under the responsibility of the manufacturer to comply with the legislation.
- If the device is for single use, information on the characteristics and technical factors that could pose a risk if the device were to be re-used.
- If the device is intended to be used together with other devices, information on the identification of the devices.
- If applicable, information on the emitted radiation.
- Information on the limitations of the device.
- If the device is implantable, information on the materials.
- Information on the safe disposal of the device.
- If the device is used by a lay person, the circumstances in which the user should consult a healthcare professional.
- Issue date and revision date of the IFU.
- A notice that serious incidents should be reported.
The importance of an IFU
The drafting of an IFU for medical devices is, for the most cases, obligatory. However, it is also functional as a manufacturer ensures to inform the user of the medical device on the intended use and any residual risks.
Therefore, drafting an IFU contributes to risk reduction of the medical device.
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You can get a third-party service provider on board to complete your testing and important certification procedures to furnish the IFU of your manufactured medical device.Leave a reply
I would like to know if the CE mark for a class II product need to affixed on the IFU.