Question 1

What are eIFU?

Accepted Answer

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.

Question 2

Why should I choose eIFU over paper instructions?

Accepted Answer

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.

Question 3

Are my products eligible for eIFU?

Accepted Answer

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.

Question 4

Is it difficult to get started with IFUcare?

Accepted Answer

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.

Question 5

What regulations do I need to comply with for my medical device / in vitro diagnostic?

Accepted Answer

That depends on the countries in which your products will be sold. 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.

Question 6

I am a MD/IVD manufacturer with a company outside of the EU. Can you still support my eIFU needs?

Accepted Answer

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.

Question 7

Can I publish my company's eIFU on our own website?

Accepted Answer

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.

Question 8

What certifications does IFUcare have?

Accepted Answer

IFUcare is part of the QbD Group and is backed by regulatory experts in IVD and Medical Devices. We operate under an ISO 13485 certified quality management system (QMS), hold ISO 27001 certification for information security, and follow the software development life cycle (SDLC) procedure based on the EN/IEC 62304 standard.

Question 9

How do you control software design requirements?

Accepted Answer

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.

Question 10

How do you handle paper copy requests?

Accepted Answer

We offer a comprehensive paper copy fulfillment service that meets all regulatory requirements: Freephone service — multilingual, available to end-users at no cost Request form on the website for convenient self-service All requests are monitored through SLA tracking within our QA system

Question 11

How do you handle validation?

Accepted Answer

Validation is embedded in everything we do: Full SDLC process in line with IEC EN 62304 Complete list of deliverables — continuous access and full version history available System maintained in a validated state at all times Quarterly releases — 60 days notification for major changes or changes with impact New features introduced as optional/configurable items to avoid disruption

Question 12

How can we get the data into your system?

Accepted Answer

We support multiple data ingestion methods to fit your workflow: Manual entry through the platform interface Bulk upload for large datasets Automated/integrated with other systems through API

Question 13

How do you handle security?

Accepted Answer

At the company level: ISO 27001 certified — with key controls covering access management, risk assessment, incident response, and business continuity At the application level: Preventive security measures built into the development process Continuous monitoring of systems and infrastructure Regular penetration testing and periodic vulnerability scans Backup and recovery testing to ensure data resilience High availability infrastructure for maximum uptime

Question 14

How are our best interests protected and compliance ensured?

Accepted Answer

We take a proactive approach to protecting your interests: Regulatory requirements are directly included into system requirements Data mapping for migration and/or requirements review as part of onboarding Training and supported configuration tailored to your needs Periodic check-ins with customers to ensure ongoing alignment Customer feedback is incorporated into our development backlog

Question 15

How does the training and onboarding work?

Accepted Answer

Our onboarding process is structured to get you up and running smoothly: Kick-off meeting and general demo for stakeholders Tailored configuration sessions covering data, logic, layout, and access roles Training sessions for individual user roles Permanent access to a sandbox environment Account configuration including domain/DNS and SSO setup Option to prepare in sandbox and migrate to production for live release

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