Does a tracking number automatically complete the request?
No. Dispatch and fulfilment are separate records. Do not assume that the system receives automatic delivery confirmation from a carrier or independently validates a tracking number.
PAPER IFU REQUEST MANAGEMENT
Paper instructions for use requests.From receipt to fulfilment.
Paper IFU request tracking for medical device manufacturers
Manage paper IFU requests alongside electronic document access. Connect the product, document revision, language, responsible team member and fulfilment evidence in one workspace.
Solution scope · Updated 5 October 2026
From a recorded request to evidence of fulfilment
- 01
Match the correct document
Review the request against the product reference, document revision, language and country. Separate paper IFU requests from other document requests and verify the approved version before dispatch.
- 02
Assign an owner and track the target
Assign an authorised team member. Track target dates under the manufacturer’s approved scope, open requests, approaching deadlines and overdue items. Review or waiting for more information does not pause the target date.
- 03
Record the review decision
Record review, requests for more information, acceptance or reasoned rejection with supporting reasons. A duplicate or bot flag is not a rejection decision by itself; assess the user separately.
- 04
Separate dispatch from fulfilment
Record dispatch evidence without treating shipped as delivered. Complete the request with evidence that instructions were provided to the user or delivered, and retain the action history.
When is a paper IFU request complete?
Receiving a request, dispatching the paper document and recording provision to the user are separate steps. eIFU Systems supports tracking these records; physical printing and delivery services require a separately agreed scope.
Example: an English Rev. B request for SAMPLE-001
In this fictional example, a user requests the English IFU Rev. B for SAMPLE-001. Product, revision, language, audience and country are assessed together. This is not a real delivery record and does not establish a fixed deadline or logistics service commitment.
- 01
Request received and assigned
Check the product and document version and identify the responsible team member. Creating a request record does not mean the user has received the paper document.
- 02
Document dispatched
Record dispatch information and evidence separately. Shipped means delivery is still pending; the request remains part of open follow-up at this stage.
- 03
Document provided
After assessing delivery or provision evidence, the authorised team records fulfilment. A status label is not independent verification that the evidence is accurate and sufficient.
Records that should remain distinct
- Document mapping
- Product, document revision and file language. Check which paper instructions should be provided together with the request record.
- Dispatch record
- Dispatch time and shipping evidence. Printing or handing a document to a carrier is different from providing it to the user.
- Fulfilment record
- Provision time and a separate evidence description. The manufacturer’s responsible team assesses the evidence and its sufficiency.
Direct answers about paper IFU request tracking
Can a shipped request still appear in the open work queue?
Yes. Shipped is different from fulfilled. A dispatched request can remain in open follow-up until a closing state such as fulfilment or a reasoned rejection is recorded.
Is a completed status sufficient without delivery evidence?
A software label is not independent proof of physical delivery. Assess the fulfilment description and supporting evidence according to your team’s process. The manufacturer separately carries out its responsibility to provide the document to the user.
Does eIFU Systems print and ship the paper IFU?
The software supports request, owner, target date and evidence records. Confirm physical printing, dispatch and logistics services separately in the written service scope.
Five checks for your demonstration
- Confirm the request matches the correct product, revision and file language.
- Review request access through the authorised team and assigned owner.
- Check the delivery-pending state after recording dispatch.
- Review dispatch and fulfilment times and evidence descriptions separately.
- Check continued target-date tracking for a request under review or already shipped.
Explore document access and product mapping →
Explore setup acceptance criteria →
Discuss your paper IFU request workflow ↗A request queue for your team
Search by request ID, product or document. Filter by status, country, language and assignee. Identify requests without an active owner, approaching deadlines and overdue items. Authorised team members work with their assigned requests.
EU scope and manufacturer responsibility
For applicable devices where electronic instructions replace paper instructions, EU 2021/2226 Article 5(3) requires a system to provide paper instructions at no additional cost to the user. The risk assessment sets the period, no later than seven calendar days after receipt of a request, or at device delivery when requested at order. Your quality and regulatory teams approve product and market scope. Do not automatically apply this EU provision to Türkiye, other markets or every document request.
Official sources and scope
Updated 5 October 2026. EU references below concern the EU framework; assess Türkiye and other markets separately.
Paper IFU request management questions
Does the platform automatically print and ship instructions?
The platform supports request records, assignment, target tracking and evidence records. Physical printing, shipping and any logistics service scope are agreed separately. The manufacturer remains responsible for fulfilment.
Does dispatch complete a request?
No. Dispatch and provision to the user are separate records. Following dispatch, record delivery or provision evidence to complete the workflow.
Does every request have the same deadline and free-of-charge scope?
Scope and timing depend on the product, market and manufacturer’s approved assessment. Requests in the free IFU scope must not incur printing or shipping charges. The absence of an automatic free-scope classification does not authorise charging.
What can we review in a demonstration?
We can discuss a sample request from receipt and document matching to assignment, target dates and separate dispatch and fulfilment records using your team’s workflow.
LET’S DISCUSS YOUR REQUIREMENTS
See the platform with your team.
We will walk through document access, revision management and multilingual publishing around your product range and markets.
Chat on WhatsApp ↗DEMO REQUEST