IFUs (Instructions for Use) for medical devices have been standard in the medical device manufacturing industry for a very long time. But with the advancement of technology, manufacturers are now considering eIFUs (electronic Instructions for Use) as their replacement.
Why is there a Need for eIFUs?
Digitalization has become prevalent all across the world. Nearly all the walks are slowly transferring themselves onto a digital platform. This shifting comes with many benefits, and the same can be implied for IFUs too.
Advantages of incorporating eIFUs in the Medical Device Manufacturing Industry
Using eIFUs instead of normal ones can be beneficial in many ways, such as:
- There is no more extended requirement of printing and managing the paper IFUs
- Manufacturers don’t have to update the processes and working instructions concerned with the printing of paper IFUs
- Transferring to eIFUs renders the need for stock management regarding paper IFUs obsolete
- eIFUs can be readily changed and updated
- eIFUS are not subjected to wear and tear like their paper counterparts.
Apart from these, there are other advantages too for eIFUs, which stresses their need in the medical device manufacturing industry.
How to Ensure the Correct eIFU implementation?
eIFU is a web-based solution, and the businesses considering to adapt it should feel different regulatory and management aspects before implementing them.
What should be considered in terms of eIFUs Compliance with Regulations?
Before incorporating eIFUs, medical device manufacturers must ensure that they fulfill all the regulatory requirements. Understanding the requirements and regulations in which these eIFUs can be used is mandatory for manufacturers. These requirements demand manufacturers meet certain conditions such as:
Ensuring the Patient’s Safety
The eIFU must not cause any harm to the patient. This can be guaranteed only when the eIFU is planted rightly under the appropriate conditions.
Devices for which the eIFU can be used
The use of eIFU is not applicable for all medical devices. There are only five types of medical devices for which eIFU can be used i.e.
- Active Implantable Medical Devices and their accessories
- Fixed-Installed Medical Devices
- Implantable Medical Devices and their accessories
- Medical Devices and their accessories having a built-in system that displays eIFU visually
- Stand-alone software.
Devices other than these five types may still require paper IFU to accompany them.
Provision of Paper IFU to the Users
Although the manufacturer may provide eIFU with the medical devices, his users may still require the paper one. Because of this, the manufacturer must ensure a compliant eIFU solution that can provide the users with paper IFU upon their request.
- Paper IFU for IVDs: For IVDs, the manufacturer has to provide a free telephone number upon which the user can call and ask for the paper IFU. This paper IFU can be sent to him via email, mail, or fax
- Paper IFU for Medical Devices: There are no clear indications from EU MDR about the method of providing paper IFU to medical device users. However, it is stated that the paper version must be provided to the user within seven days after he has made the request. Also, the manufacturer will not charge the user for providing the paper IFU.
Website Compliance
The website on which the manufacturer will upload the contents of eIFU should also meet some standards. These include:
- The proper functioning of the website
- For the patients, the process of retrieving information of eIFU should be given in a language that the user can easily understand
- Contents of the eIFU should be identical to the paper IFU
- The contents of eIFU should be in the read-only format (e.g. pdf)
- The website must be secure from any hardware and software intrusion.
What are Regulations and Restrictions Imposed on eIFU?
Many regulatory restrictions apply on eIFU, such as:
- As per the privacy regulations, users’ data cannot be captured without their consent
- The manufacturers must keep the eIFU updated on European MD and IVD websites
- Aside from the aforementioned devices, all the other devices must be provided with eIFU and paper IFU.
What are the Impacts of eIFU on the Organization’s Quality Management System?
Shifting to eIFU from paper IFU has a significant impact on the organization’s QMS. Therefore, it must take some steps to make this transition successful. These steps include:
Following the Organization’s Change Control Procedure
Before it transitions to eIFU, the organization must follow its change control procedures thoroughly.
Risk Analysis
The organization should perform a detailed risk analysis to determine any additional risks the patients might face if they do not get a paper IFU.
Validation of the eIFU Solution
The manufacturer must make sure to validate the eIFU solution and keep it in a steady state.
Informing the Notified Body
The manufacturer must ensure informing Notified Body regarding its switching to eIFU.
Outsourcing the eIFU Solution
If the organization decides to outsource the development of its eIFU solution (or use a complete outsourced solution), then
- It must select and qualify the outsourcing supplier as a critical supplier
- It will have to justify its supplier towards its Notified Body. The suppliers that are certified with ISO 13485 and ISO 27001 are easier to justify.
What Labelling Requirements does the Manufacturer need to Fulfill?
The manufacturer must fulfil these labelling requirements:
- He should include clear instructions for the people regarding obtaining their eIFU
- He should inform the customers about the methods through which they can request their paper IFU copy
- The manufacturer can consider his eIFU files into multiple languages so that the patients can find them easily in their preferred language
- The manufacturer must use a harmonized and comprehensible symbol for indicating eIFU use for his label.
With eIFU, the manufacturer can surpass many printing-related restrictions. eIFU allows him to add high-resolution images, colors, and videos to make it easier for the user to understand the device’s working.
Should the Manufacturer Communicate the Customers about Transition to eIFU?
The manufacturer should ensure that he informs his customers before he transitions to eIFU. He should also provide them with instructions on how to obtain the IFU in the future.
Alysidia is helping in providing with eIFUs
Alysidia understands the importance of eIFUs for the medical device manufacturing industries and the pharmaceutical sector. Therefore, we are providing eIFU solutions to these healthcare sectors. Our solutions comply with all the applied regulations and can easily be used across all appropriate platforms.
