With the technological advances, medical device manufacturers are now considering eIFUs (electronic Instructions for Use) as replacements for paper IFUs.
Why are eIFUs needed?
eIFUs are required to cope with the extensive digitalization in the modern world. In reality, using eIFUs provides medical device manufacturing companies with many benefits compared to their paper counterparts. Some of these benefits of eIFUs include:
- Manufacturers don’t have to update the processes and working instructions concerned with the printing of paper IFUs
- There is no need for stock management after transitioning to eIFU
- With eIFUs, there are many possibilities to upgrade or change them
- eIFUs do not face any damage as compared to paper IFUs.
What Considerations are Important for the Correct Implementation of eIFUs?
There is an immense need for medical device manufacturers to fulfill several regulatory conditions before they decide to implement the eIFU. Also, there are many management requirements to be looked after.
What should Manufacturers consider in terms of eIFUs Compliance with Regulations?
The manufacturers must understand specific requirements and regulations before they implement eIFUs in their medical devices. These regulatory and QMS requirements include:
Specified Devices for which the eIFU can be used
eIFUs cannot be enforced upon all medical devices. According to the Regulations, there are only five classes of medical devices upon which the eIFUs can be implemented. These five classes are:
- Active Implantable Medical Devices and their accessories
- Implantable Medical Devices and their accessories
- Medical Devices and their accessories having a built-in system displaying eIFU visually
- Stand-alone software
- Fixed-Installed Medical Devices.
eIFU will still accompany devices that do not belong to these five classes.
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eIFU Website Compliance
There are some requirements needed for the websites that display the information of eIFU. These requirements require manufacturers to
- Ensure that their website functions correctly
- Make the content of eIFU identical to the paper IFU
- Make the eIFU content available in the read-only format (e.g. pdf)
- Design their website such that it remains secure from any external hardware or software intrusion
- Information of eIFU should be in a comprehensible language for the patients.
Requirement of Paper eIFU by the Users
Despite the availability of eIFU, many users still require paper IFU. Therefore, the manufacturers must ensure that a compliant eIFU solution is present to assist such users. There are two methods of providing the paper IFU solution:
- Paper IFU for Medical Devices: There are no clear indications from EU MDR about the paper IFU to the medical device users. But it is explicitly mentioned that the paper version must be provided to the user within seven days after making the request. The manufacturer will not charge the user for providing the paper IFU
- Paper IFU for IVDs: For IVDs, the manufacturer has to provide a free telephone number upon which the user can call to ask for the paper IFU. The modes via which this paper IFU can be sent to him include
Ensuring Safety of the Patients
eIFU labels should be placed such that they do not cause any harm to the patient.
What are Regulations and Restrictions applied upon eIFU?
The use of eIFU in medical devices is bounded by regulations and restrictions. These bound the manufacturer to
- Not capture patient’s data without their consent
- Keep updating the eIFU information on European MD and IVD websites
- Apart from the five classes of devices mentioned, all other devices with eIFU will also be accompanied by the paper IFU.
How do the eIFU impacts the Organization’s QMS?
There are many ways by which the eIFU implementation can affect the organization’s QMS. Therefore, it is necessary to take some steps to ensure that this transition is done correctly. These steps are:
Performing a Detailed Risk Analysis
The organization should perform a detailed risk analysis to determine any additional risks the patients might face because of not getting a paper IFU.
Informing the Notified Body
The manufacture should ensure that he informs the Notified Bodies regarding his transition to eIFU.
Implementation of the Organization’s Change Control Procedure
The organization should implement its change control procedure before transitioning to eIFU.
Ensuring the Validation of the eIFU Solution
The manufacturer must ensure that the eIFU solution is validated and kept in control.
The decision of Outsourcing the eIFU Solution
If the organization has decided to outsource its eIFU solution’s development (or use a complete outsourced solution), then
- It will select and qualify its outsourcing supplier as a critical supplier
- It will have to justify its supplier towards its Notified Body. It is important to note that the ISO 13485 and ISO 27001 certified suppliers are easier to justify.
Is there a Need for the Manufacturer to communicate to his Customers about Transition to eIFU?
The manufacturer should ensure informing his customers that he is going to transition to eIFU. It is also his responsibility to tell them about how they can obtain the IFU in the future.
How Many Labelling Requirements are there for the Manufacturer to Fulfill?
Following are the labelling requirements the manufacturer must fulfil:
- Including clear instructions for the people on how to obtain their eIFU
- Informing the customers regarding methods to request their paper IFU
- Uploading his eIFU files into multiple languages so that the patients can find them easily in their native language, and
- Using a comprehensible symbol for indicating eIFU use for his label.
TSQ & E can Help with providing with eIFUs
The regulatory experts at TSQ and E are well-aware of the importance of eIFU for medical device manufacturers. Therefore, they have come forward with comprehensive eIFU solutions that are very easy to incorporate and are compliant with all the regulatory requirements.