It is extremely important that the medical devices are CE marked because only those devices can be placed on the market. The CE mark shows that the device meets the legal requirements for the medical devices.
Part of the CE marking process is drafting the Instruction for Use (Hereafter: IFU). Now that we’ve learned why it’s important to have CE marking on the devices, let’s take a look at which devices qualify for IFU drafting.
The medical devices are categorized into classes (I, IIa, IIb, III for Medical Devices / List A and B for IVD Devices) based on the risk factor. The Medical Devices Regulation (EU) 2017/745 (hereafter: MDR) states that an exception is made for class I and class IIa medical devices.
It is important to note that an IFU is necessary when the devices require specific instructions on a comprehensive cleaning procedure, sterilization procedure or information on how and when to re-use the device.
What information the IFU must 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.
- 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.
- An indication of its sterile state and sterilization method if the device is supplied in a sterile state.
- If the device is intended for single use or not.
- The information on the in vivo use.
- The intended purpose of the device as well as the intended users and patient groups.
- The expected clinical benefits.
- The performance characteristics of the device.
- 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.
- Instructions when the packaging is damaged or unintentionally opened.
- Instructions for the sterilization before the use.
- Information for allowing its reuse.
- An indication that the device can only be reused if it is reconditioned under the responsibility of the manufacturer to comply with the legislation.
- 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 and which ones.
- Information on the emitted radiation.
- Information on the limitations of the device.
- Information on the materials if the device is implantable.
- Information on the safe disposal of the device.
- The circumstances in which the user should consult a healthcare professional if the device is used by a lay person
- Issue date and revision date of the IFU.
- A notice that serious incidents should be reported.
The importance of an IFU
Drafting an IFU contributes to risk reduction of the medical devices. For the majority of the cases, it is important to draft an IFU.
What to keep in mind when drafting an IFU?
It is very essential to keep in mind that not all of the above mentioned instructions are applicable for all the medical devices. It might seem like an overwhelming process because it is, and that’s where you come to us.
Certification Experts service and support
We do not only specialize in IFU drafting but also help you ease out and navigate the 5 important steps for CE marking, which are:
- Division according to the medical status and class
- Evident compliance to the Essential Requirements
- Technical Documentation
- Conformity Evaluation
- Declaration of Conformity
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