Medical devices, perhaps more than any product, demand effective, efficient, and readily available user manuals. Instructions for Use (IFU) for medical devices have traditionally been paper-based but the advent of electronic technologies opened up the possibility of digitizing IFUs for medical (MD) and in vitro diagnostic (IVD) devices.
What are eIFU?
eIFU stands for “electronic instructions for use“, but the term encompasses more than just these documents. It also includes the online distribution of other regulatory documents, such as certificates of analysis, safety data sheets, and quality control documents. eIFU can be made available via a manufacturer’s website but due to the strict regulations, these websites must be validated for compliance. myHealthbox removes this burden and offers a pre-validated platform to store, manage and distribute these documents. Moreover, maintenance and continued compliance are ensured.
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Make changes faster
If changes need to be made, it takes time to recall a product, replace the paper IFU and redistribute the product. With electronic IFUs, updates can be made in minutes, reducing the likelihood of a product recall.
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Reduce risk
Providing eIFUs with better readability and ensuring that documents are always available reduces the risk of errors and improves patient safety. Our eIFU platform is validated and compliant with regulations, so Notified Bodies will be more willing to accept. We also take care of automatically recording changes to your documents or the website, and our broad language support makes it easier for end users to find the correct documents.
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Save paper and process costs while embracing sustainability
Switching to eIFU is better for the environment and saves your company the cost of printing and managing documents. It also reduces packaging and shipping costs. Avoid content fragmentation by having documents stored in a single rather than multiple locations.
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Simplify your processes
We make your eIFU easy to access and keep track of all version changes. We believe that technology should make your and your customers’ lives easier. Our solution is full-service thus minimizing the impact on your organization.
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Manufacturing Benefits of eIFU
With eIFU you not only save on paper but also on associated costs. For manufacturers, saving money on paper, ink and printing costs is one reason to consider eIFU, as well as the lessened environmental impact associated. With paper manuals removed from packaging, boxes may be reduced in size, creating potential further savings on packaging materials and warehouse capacity. For cases when, due to regulatory restrictions, paper manuals still need to be provided, we offer a "paper reduction" solution which combines minimal paper manuals with extensive digital instructions.
Removing the paper manual from the box has other positive impacts on the packaging process. For example all checks required to make sure that the correct IFU is in the correct box can be removed. Errors like these would typically lead to expensive product recalls and the physical replacement of the paper IFU. While the occurrence of these events would normally be reduced by in-process controls to verify packaging contents, with eIFU none of this is necessary.
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Eliminate limitations of printing and improve readability
With eIFU you have more options for displaying information – they can be in larger font, and can include colours and images to make them easier to understand. Just leverage the multimedia capabilities of our eLeaflet solution for providing a better user experience.
myHealthbox full-service eIFU solution
Our eIFU solution enables medical device (MD) and in vitro diagnostic (IVD) manufacturers to leave paper instructions for use (IFU) out of product packaging and make them accessible online. Our platform is EU/FDA regulation compliant and can be configured to suit your needs. Distinct groups of documents can be made available for different countries, languages, production lots or user groups (i.e. patients, HCPs).
What we offer
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Support for all formats
We are not limited to working with formats like PDF or Word but also support all the new semi-structured formats like ePI, JPL, SPL, etc. so if you want to take advantage of these new formats, you can. Good news is you can mix the different formats meaning that you can still use PDFs but enhance them with our eLeaflet solution to deliver multi-media, multi-language or any other advanced feature. All guaranteed under the same secure architecture.
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A GMP Validated solution
Our platform is validated against the FDA 21 CFR part 11 and EMA GMP Annex 11 guidelines.
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Secure delivery and locked content
Digital keys guarantee that what users access is the approved document, making sure that once approved and released its content cannot be modified. We provide full traceability from editing to delivery and support content notarization for companies looking for enhanced legal insurance.
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Changes notification
As a manufacturer, you are required to notify customers who have previously downloaded an IFU on your website in the event of an update. Our platform includes an automated system to handle these notifications.
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Document versioning
We support document versioning by language, country, production lot or any combination of these.
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Global service
Leverage our global service, languages support and user base to improve your eIFUs availability and visibility.
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Packaging integration
We support most barcodes for easy integration of your eIFU with your packaging and paper labels. We also support the newest GS1 DataMatrix and QR Codes with the GS1 Digital Link Standard with support for serialization, expiry date and lot number attributes that can be generated on the production line.
More information about the eIFU solution from myHealthbox and how we can help you comply with these new regulations is available on the eLeaflet website or contact us at info@myhealthbox.eu