eIFU resources

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. IFUcare removes this burden and offers a pre-validated website, that still matches your corporate identity. Moreover, maintenance and continued compliance are ensured.

Using eIFU has many benefits over paper instructions: in addition to reducing packaging which makes your products more environmentally friendly, it allows you to make faster changes to your documents as needed, reduces the risk associated with product recalls, saves the cost of paper and the service costs around updating your documents, and keeps you stay up-to-date with the technological demands of the modern world.

Discover all benefits here.

Medical devices and in vitro diagnostics are required to be provided with an IFU. Depending on the country and product type, they can be on paper or electronic. Products which fall into these categories can have eIFU. Contact us for more details.

Not at all! We have a team of support care staff who are available to provide you with training, access to manuals (for using the website as well as for implementing eIFU), access to a test site to play around in before using the ‘real’ account, and to answer any questions you may have.

That depends on the countries in which your products will be sold. See the top of this page for a list of common regulations, directives and guidelines for different countries. The IFUcare team is well versed on the regulations around MDs and IVDs, and will make sure that the eIFU site that we create for your company will be compliant for all market countries that accept eIFU. If you need expert advice, do not hesitate to contact us.

The location of your company does not determine eIFU acceptance. Instead, you should review the local regulations in the countries where you sell your products to evaluate whether they accept electronic instructions as replacement for paper.

To find out where eIFU are accepted, please contact us here.

It could be possible, but you will have to ensure that your website complies to the strict requirements as described in various regulations and guidances, and becomes integral part of your quality management system (QMS).

The combined impact on the website and your organisation cannot be underestimated:

• The website must be kept in a validated state (change control)
• The website must be protected against intrusion in an ever-changing threat spectrum  
• Website usability must be verified to ensure smooth and correct access to information
• Supporting services and systems must be in place to supply users with paper copies upon request, free of charge
• Regulatory intelligence must be aligned with IT services to ensure that the website remains in compliance with latest regulations

Understanding the tremendous resources needed to meet all of these requirements, it is easy to see that it is more straightforward and cost-effective to outsource your eIFU to the off-the-shelf solution of IFUcare. Partnering with us provides you with the peace of mind that these challenges are under control, allowing you to focus on your core business.

IFUcare is a service of Qarad. Qarad has an ISO 13485 certified quality management system (QMS), ISO 27001 certification for information security, and we follow the software development life cycle (SDLC) procedure based on the EN/IEC 62304 standard.

IFUcare controls software developments and validation by working according to a very strict software development life cycle (SDLC) procedure, which is based on the EN/IEC 62304 standard. 

Download our practical steps to ensure a successful eIFU implementation here.