TRANSITION CHECKLIST FOR MANUFACTURERS
An eIFU implementation checklist for medical device manufacturers
Start with your product, document language and market inventory. Assign an owner, expected output and acceptance check to each preparation step. This plan supports the manufacturer’s setup discussion; completing it does not establish regulatory compliance.
Manufacturer guide · Updated 6 October 2026
Choose a defined initial product range. Record references/GTINs, intended users, countries and responsible teams. Quality/regulatory owners assess scope; operations prepares the inventory for technical setup. Output: initial scope with named owners and open issues.
Have your quality and regulatory teams assess market requirements and the impact of electronic access on users. Define an approach for users without internet or suitable devices. Output: a recorded assessment and decision.
Map document types, current revisions, required languages and approval status to each product. Complete missing files and translation reviews before publication. Output: a product–document–language inventory.
Separate the uploader from the authorised reviewer. Treat approval and portal publication as distinct decisions; check the risk record, paper request owner and required approved language coverage. Output: review record, publication decision and scope basis.
Test product search, QR links, language selection, file opening and support or paper-copy requests using representative user journeys. Output: test results and assigned corrective actions.
Assign ownership for updates, previous versions, persistent links and interruptions. Test backup restoration and monitor access after publication. Output: an operating and review plan.
Use this table as your team’s preparation record; it is not automatic setup or regulatory approval. Add a named owner and target date for each gap.
| Input | Record to prepare | Suggested owner |
|---|---|---|
| Product identifiers | Product name, reference/REF, GTIN where available, and the products mapped to each document. | Product / operations team |
| Documents and languages | Document type, revision, file language, approval status and missing required language versions. | Document control / quality team |
| Audience and market scope | Intended user groups, countries and assessed document/language scope for each product and market. | Quality / regulatory team |
| Review and publication authority | Uploader, independent reviewer and publication decision owner, with authority boundaries. | Quality and company administrator |
| Portal and existing links | Logo, brand colour, planned domain, printed QR codes/addresses and product link mappings. | Company technical owner |
| Paper-copy process | Request recipient, applicable target time, printing/dispatch owner and fulfilment evidence. | Support / operations team |
| Operations and continuity | Owners for access incidents, document updates, backup/restoration and periodic review. | Technical and quality teams |
Example scope: one product, Turkish and English files, two target markets. This is a planning example only; it does not mean these languages are sufficient in both markets. Your team determines required languages and electronic delivery eligibility for each product and market.
Record these checks for a limited initial scope. Run publication/withdrawal trials in a test environment without affecting customer access.
| Check | Expected result | Evidence to record |
|---|---|---|
| Product search and QR | Reference/GTIN search finds the correct product; a shared QR opens search and a product QR opens the relevant product. | Product reference, tested URL/QR and result screen. |
| Audience, country and document language | The selected scope offers the correct published file; interface and file language are checked separately. | Product–country–audience–language selection and file revision. |
| Review versus publication | The uploader cannot approve their own file; approval alone does not publish the file in the portal. | Action result, reviewer and publication decision record. |
| Missing languages and publication scope | A missing required approved language file blocks publication; reassess once scope is complete. | Missing scope, blocked result and decision after correction. |
| New revision and persistent link | When the same product record and link are retained, the new publication opens in the correct scope and earlier decisions remain recorded. | Product URL, before/after revision and history record. |
| Paper request and delivery tracking | The request maps to the correct product/language with an owner and target date. Dispatch is tracked separately from fulfilment/delivery evidence. | Request reference, owner, dates and status evidence. |
Each test record should contain the date, tester, expected/actual result and evidence reference. Close open issues; have the quality/regulatory owner review the scope decision, the technical owner review access results and operations review the request process. These records support setup assessment; they are not an independent validation certificate or evidence that every regulatory obligation has been completed.
Discuss your products, languages and markets ↗Before the first release, check the backup copy, restored records and user access separately. The scenario below is a starting point for agreeing the scope with your team.
Use a defined sample product with a current revision, a previous revision, a language version and a recorded paper-copy request. Compare the restored files and their product mappings with the agreed inventory. Then reopen the same product QR link and check that the expected document scope is available. Record each result and any unresolved difference.
A backup record shows that a copy was created. Restoration acceptance requires a separate test of the recovered files, associated records and access paths. Keep the backup identifier, test environment, restoration time, inventory comparison and acceptance decision together. Use an isolated environment for the test.
Agree the maximum acceptable data loss and the target time for restoring access for the intended scope. Identify the records and dependencies included in those targets, such as document files, product mappings and domain configuration. A successful sample restoration is evidence of that test; it does not establish a service-wide uptime guarantee.
Test the printed product link as well as a direct file address. Select the intended audience, country and document language, and compare the displayed revision with the accepted inventory. Record a missing-language case and the handling of previous or withdrawn revisions. A working file URL alone does not verify the whole access workflow.
Record the agreed scope, expected and actual results, remaining issues, responsible owners and the acceptance decision. Repeat failed checks after corrections. Keep the supplier’s operational commitments separate from the manufacturer’s acceptance record and assessment of obligations in each target market.
Keep product scope, document mappings, independent review and publication decisions with access test results. Record the test date, tester, product–revision–language–country selection, expected and actual result, and evidence reference. Assign an owner and target date to each open issue; resolve critical content or access defects before publishing the affected scope.
For relevant devices supplied with electronic instructions instead of paper under EU 2021/2226, a documented risk assessment and a process for providing requested paper instructions at no additional cost are required. Your team should verify applicable timeframes and access conditions in the current text. Assess Türkiye and other markets separately.
Updated 5 October 2026. EU references below concern the EU framework; assess Türkiye and other markets separately.
Define scope by product and market. Validating mapping, publication and access in a limited initial scope can help your team identify gaps.
No. This is a preparation checklist. Product eligibility and regulatory obligations require assessment by the manufacturer’s responsible teams.
Check that the correct product shows the correct approved document and language version, links work and requests reach the responsible team.
Start with product references, document types/revisions/languages, intended users and countries, review/publication owners, existing QR links or addresses, and the owner of paper-copy requests. List gaps too; do not send patient information or confidential files.
LET’S DISCUSS YOUR REQUIREMENTS
We will walk through document access, revision management and multilingual publishing around your product range and markets.
Chat on WhatsApp ↗DEMO REQUEST