Can an EU Professional-Use Device Ship Without a Paper IFU?

The procurement scenario: a supplier proposes dropping the paper IFU

You distribute sterile consumables to EU hospitals. An overseas supplier proposes replacing the instruction booklet with an online file and access information on the packaging. The proposal may reduce printing and packing work, but the receiving decision is specific: can this device, in this market, with these users, arrive without its paper instructions? This guide is for distributor QA teams, private-label buyers and hospital procurement managers making that acceptance decision.

Ask for the proposed label artwork, the device and document identifiers, the destination languages, and the manufacturer’s basis for switching instruction media. Check the actual sales-pack configuration before the first revised shipment. An online file that opens successfully is only one part of the evidence. It does not establish that patient-facing instructions can disappear or that paper delivery works.

MDR Articles 13 and 14 give importers and distributors their own verification duties, including checks on the information supplied with the device. Those duties are distinct from the manufacturer’s Article 4 eIFU assessment. A distributor need not pretend to repeat the entire conformity assessment, but should escalate inconsistent or missing information before making a device available.³

In this guide

• What changed and which evidence remains necessary
• User eligibility and the lay-use boundary
• Label and access-information checks
• Paper delivery and language responsibilities
• Website availability and retention clocks
• EUDAMED records and transition checks
• Shipment acceptance scorecard
• RFQ and supply-agreement terms
• Buyer questions

What changed on 16 July 2025 — and what did not?

Regulation (EU) 2025/1234 was adopted on 25 June 2025, published on 26 June, and entered into force on 16 July. It replaced the old Article 3(1) catalogue of eligible implantable, fixed-installed and built-in-display devices with a professional-user test. The extension includes MDR medical devices and accessories, professional-use Annex XVI products, and devices covered by the Article 120 transitional provisions.¹

This is permission to change instruction media under conditions, not permission to omit necessary instructions. Nor does it mean every consumable previously needed a separate printed booklet: MDR Annex I Section 23.1(d) has a distinct, conditional IFU exception for certain Class I and IIa devices that can be used safely without instructions. This guide addresses replacing required paper instructions with electronic instructions.³

The amendment did not change Article 4. The manufacturer must undertake a documented risk assessment, update it with post-market experience, and demonstrate that electronic delivery maintains or improves the safety level obtained with paper. Article 5 also requires verification and validation evidence for the design and functioning of the electronic instructions.¹²

For buyer review, request a product-specific assessment summary and the evidence that addresses your customers’ use environment. A complete confidential technical file may not be provided to a distributor. An agreed summary, controlled review or other appropriate evidence can establish what was assessed without representing that the buyer has acquired the manufacturer’s regulatory responsibilities.

• User evidence: knowledge, experience and needs; use environment; hardware/software competence; and access to electronic resources at the time of use.
• Failure evidence: protection against tampering; hardware/software backups; foreseeable medical emergencies requiring paper information; and the impact of website, internet or institutional-access outages.
• Service and document evidence: the assessed paper-request period, compatibility of the website with display devices, and management of instruction versions. These groups summarize the eleven Article 4 elements; the supplier’s assessment must address the actual elements.²

Which users qualify, and when must lay instructions remain on paper?

The amended definition of professional users refers to persons using the device in the course of their work in a professional healthcare activity. It is not a rule about where the building is located. A professional working in community care is not automatically a lay user, while a patient using a device at home is not made professional by an initial training session.¹²

Under amended Article 3(2), reasonably foreseeable lay use of a professional-use device brings back paper for the instructions intended for those lay persons. Merely being the recipient of a procedure, wearing a device passively or touching its packaging is not a complete eligibility analysis. Ask who operates, adjusts, removes or otherwise uses the particular device, and which instructions those people need.¹

The examples below are conditional sourcing questions. They do not certify a circumcision ring, laser fiber, puncture kit or NPWT line as eIFU-eligible, and they do not recommend a clinical care pathway. The manufacturer must assess the labeled workflow and reasonably foreseeable use of the actual model.

Software covered by MDR has a separate provision: Article 3(3) permits instructions through the software itself instead of paper. IVDs are outside the MDR eIFU implementing regulation. IVDR Annex I 20.1(f) permits non-paper instructions for professional-use-only devices except near-patient testing; it does not state a blanket “central laboratory only” eligibility test. Electronic supplements must not be confused with lawful replacement of required paper.²⁶

MedTech Europe, Eurom and EuromContact called for further lay-user eIFU expansion on 23 September 2025. That is an industry policy request, not permission for a supplier to omit currently required lay-person paper instructions. A future proposal or guidance discussion should not be used as the basis for accepting a changed pack.⁷

What must the label and access information carry?

Article 6 requires the label to clearly indicate that instructions are supplied electronically instead of on paper. That indication belongs on the packaging for each unit or, where appropriate, the sales packaging. Access information is supplied in that location or, if this is not practicable, in a paper document supplied with each device. Fixed-installed devices and software have their own location provisions. There is no universal rule that every access detail must be printed on the sterile pouch.²

• Viewing information: what the user needs to access and view the instructions.
• Identification: the Basic UDI-DI and/or UDI-DI, plus additional information identifying the device, including its name and model where applicable. The rule does not say both identifiers are invariably required.
• Contact: relevant manufacturer contact details, such as name, address, email or another online communication route and website.
• Paper route: where and how paper can be requested, the period within which it will be obtained, and that it is supplied at no additional cost.²

For acceptance testing, scan the code and use the alternative access method described by the manufacturer. Confirm that the user can identify the applicable model, market, language and document revision. A readable URL alongside a QR code can be a sensible purchasing requirement for customers without scanning access. Article 6 does not prescribe a universal QR layout or compulsory ISO 15223-1 symbol. Evaluate any symbol against the applicable labeling requirements and the device-label symbol guidance.²³

Article 6(5) requires a complete text version, which may include graphics and symbols, containing at least the information in the paper instructions. Video or audio can supplement the text. A demonstration video alone does not meet this rule. During sample review, compare the current paper master with the electronic file and record any missing warnings, identification information or language content.²

A device eligible for eIFU may still need physical information: Article 5(4) requires information about foreseeable medical emergency situations on the device or a leaflet. Therefore, “electronic instructions permitted” and “no paper anywhere in the pack” are different conclusions.²

How fast must requested paper arrive?

Article 5(3) requires a system to provide paper instructions at no additional cost to the user, within the period established in the risk assessment and at the latest within 7 calendar days of receiving the request. If paper is requested at the time of order, it must be provided at device delivery. The assessed period may be shorter than the maximum.²

Define receipt of the request, acknowledgment, printing and delivery as separate events in the supplier discussion. Sending a PDF or dispatching a courier on the final day does not demonstrate that the paper has been provided within the period. Test a realistic destination and language rather than only a domestic delivery near the factory. Retain the request, timestamps, received copy and result.

For example, a hospital requests paper when ordering. The distributor should transmit that request through the agreed process and confirm the delivery arrangement before shipping. A supplier’s preference for electronic instructions does not override the at-delivery condition. Where the customer requests paper later, the free paper system still applies.²

Language requirements follow the official Union language determined by the Member State in which the device is made available. Article 5(11) sets this requirement for the website. Establish the required language versions for each destination and the matching paper copies under the applicable MDR requirements. Do not assume that every country requires every official EU language, or that the eIFU regulation universally demands a “certified translation.”²³

A local printing arrangement may help meet the service period, but it needs manufacturer-approved content, revision control and an agreed responsibility for fulfillment. Translating, relabeling or repackaging raises separate MDR Article 16 questions. A supply clause cannot by itself authorize regulatory activities or create a right to deduct costs from invoices.³

What must remain available after the last sale?

Article 7 requires commonly used formats readable with freely available software, protection against unauthorized access and tampering, server downtime and display errors reduced as far as possible, GDPR compliance, and a stable, directly accessible address during the retention periods. The text specifies outcomes; it does not prescribe one hosting architecture or declare every CAPTCHA or cookie interaction unlawful.²

Ask the manufacturer to demonstrate retrieval from an ordinary customer device. Check whether a login, software purchase, confusing redirect or language selection problem prevents timely access in the assessed environment. Account-free access can be agreed as a purchasing condition. A brief buyer test supports acceptance; it cannot prove long-term uptime, cybersecurity or GDPR compliance.

For an expiry-dated non-implantable device, the two endpoints are 10 years after the last device is placed on the market and at least 2 years after expiry of the last produced device. Both must be met. Devices without a defined expiry date and implantables require 15 years after last market placement. These clocks are not measured simply from the final factory shipment, production stop or last hospital purchase.²

In a hypothetical non-implantable line, last market placement in 2026 would create a ten-year endpoint in 2036. If the last produced device expired in 2035, the two-year post-expiry endpoint would instead be 2037, so availability must reach that later date. The example illustrates the rule; it is not a shelf-life claim for any VEMERIX product.²

Amended Article 5(13) requires issued electronic versions and publication dates during the applicable periods; obsolete versions may be supplied upon request instead of remaining publicly listed. Article 5(8), which remains in force, requires a revision system and notification of each device user when a revision is necessary for safety. Ask how an old lot maps to its applicable version and how safety revisions reach affected users.¹²

What can the EUDAMED record establish?

Decision (EU) 2025/2371 was adopted on 26 November 2025 and published on 27 November. The Commission confirms mandatory use of the actor, UDI/device, notified-body/certificate and market-surveillance modules from 28 May 2026. The decision declares functionality; the transition dates follow the roll-out provisions and Commission implementation materials.⁴¹¹¹²

Amended Article 7(3) ties submission of the eIFU internet address to the applicable device-registration date under MDR Article 123(3)(d) or (e). MDR Annex VI Part B point 22 describes an optional additional-information URL, but the eIFU implementing rule makes provision of the relevant address a duty for manufacturers using electronic instructions under that rule.¹³

Search the public device information with the identifiers provided by the supplier. Match the manufacturer, device/model and relevant identifier, then open the address and confirm the instruction language and version. Legacy identifiers may differ from an MDR Basic UDI-DI. Keep the search date and matching details. Use the identifiers and information shown in the current public interface to document the match.

A missing record or address needs a timing check. For an MDR/IVDR device first placed on the market from 28 May 2026, the Commission’s materials require registration before placing. Certain legacy or Regulation device identifiers first placed earlier, with further units still placed after mandatory use, fall within the transition whose Commission graphic prints 28 November 2026. It is not a blanket extension for every new model, every legacy product or every warehouse lot.⁹¹²

During this October 2026 window, ask the manufacturer which provision applies, when the first unit of the relevant identifier was placed, whether further units are still being placed, and when the record and eIFU address will be entered. Record a review date before the applicable deadline. Where registration already applies, an absent or broken eIFU address warrants escalation. Where a supported transition applies, absence alone is not conclusive noncompliance.¹⁹¹²

A populated URL proves only that an address was recorded. It does not prove user eligibility, free paper fulfillment or completeness of the risk assessment. For the full device-record timing analysis, see when a missing EUDAMED device record can remain within a transition. The receiving decision should combine record evidence with the physical label and manufacturer’s explanation.

A shipment acceptance scorecard

Use the following editorial scorecard for the exact model, configuration and destination. It is a purchasing aid built from the cited rules, not a published VEMERIX quality procedure. Assign an owner and record the evidence reviewed for each line. Where a distributor has reason to believe a device does not conform, MDR Article 14 requires it not to make the device available until conformity is restored and to inform the relevant operators.³

Keep the acceptance record specific: legal manufacturer, model, identifier, lot/configuration, destination, IFU revision, artwork revision, reviewer and outstanding action. Useful results are “accepted for this configuration,” “awaiting this evidence” or “held for this confirmed nonconformity.” A blanket approval of an entire supplier’s eIFU program is wider than this receiving review can support.

Removing a booklet may change how a pack is supported during transport, but it does not automatically invalidate sterile-barrier validation. Request the manufacturer’s change assessment and any validation it identifies as necessary. Keep this distinct from the eIFU regulation; our sterile-barrier and shelf-life evidence guide addresses the packaging question in detail.

What should the RFQ and supply agreement specify?

Use the points below as an RFQ schedule and drafting brief. They are proposed commercial terms built on the legal requirements, not mandatory contract wording or automatic remedies. The parties should adapt them to the distribution role and applicable contract law.

• Configuration and change notice: identify the models, destinations, users and instruction media covered. Require approval of revised artwork and notice before changing paper content, URLs, fulfillment routes or language coverage.
• Eligibility evidence: agree what product-specific risk-assessment and validation evidence the supplier will make available, by what route, and how changes or post-market findings trigger review.²
• Paper fulfillment: specify the request channel, receipt timestamp, required language, accountable owner and evidence of delivery. Preserve the Article 5(3) period, the free-paper requirement and paper at device delivery when requested at order.²
• Controlled local support: if local printing is proposed, define approved masters, authorization, revision checks and responsibility for costs. Separately assess any translation, relabeling or repackaging obligations and agree the authority for local fulfillment.³
• Website continuity: specify retention using market-placement and expiry endpoints, historical-version access, safety-update notification and a continuity arrangement if the platform or supplier changes.¹²
• Record and exception handling: identify who supplies the eIFU address to the device record, any supported registration transition, the entry date, and the process for resolving failures. Negotiate cost allocation or remedies explicitly rather than presenting indemnity as an eIFU statutory duty.¹⁹

A practical RFQ response should attach a model-by-market schedule rather than a single “eIFU compliant” checkbox. Include the proposed pack revision, electronic document revision, required paper portions, destination languages, paper service period, and registration status. This makes it possible to accept one validated configuration while leaving another unresolved.

Keep other destination rules separate

Swissmedic’s notice of 8 August 2025 confirms direct Swiss application of Regulations (EU) 2021/2226 and 2025/1234 under MedDO Article 95(1). It describes the professional-use extension, continued paper for lay instructions and eIFU address provision when registering devices. Check Swiss device registration and local roles separately before accepting a Swiss shipment.⁵

The US electronic-labeling provision in 21 U.S.C. § 352(f) covers specified prescription devices and professional-use IVDs, subject to all applicable law. It requires requested paper promptly and without additional cost; it does not supply the EU calendar-day rule. An EU instruction-media decision therefore cannot simply be copied into US or other destination artwork.⁸

Where VEMERIX fits — and what to request

VEMERIX is the international brand of Weihai Medison Medical Equipment Co., Ltd., positioned as a Minimally Invasive Surgery Total Solution Platform serving urology, vascular surgery and perioperative care.

The public product page describes the Circumcision Device as a self-detaching ring supplied in individual sterile blisters and states CE status. Those portfolio facts do not establish eIFU-only shipment eligibility, the current IFU medium, a completed Article 4 assessment or an EUDAMED record. Because the ring remains after the procedure, the applicable user instructions should be established from the current product documentation.¹⁰

For a distributor discussion, send the target country, model/size range, intended customers and paper requirements through the VEMERIX contact form. Request the current IFU, label artwork, applicable conformity documents and instruction-delivery arrangement. Ask for eIFU assessment and fulfillment evidence if that configuration is offered. An enquiry starts this evidence review; the article does not promise that a particular electronic-only configuration is available.

Frequently asked questions

Does professional operating-theatre use automatically permit eIFU?

It supports the user criterion, but is not the whole decision. The manufacturer must establish the assessment, validation, access information, complete text, paper system and applicable record duties. Risk class alone does not determine eIFU eligibility.¹²

Does a device going home with the patient always need paper?

Establish whether lay use is reasonably foreseeable, and which instructions are intended for those lay users. If the Article 3(2) condition applies, those instructions must be supplied in paper form. Do not equate home location or passive patient contact with a documented user assessment.¹

Can the buyer agree to slower or paid paper delivery?

A purchasing agreement cannot remove the manufacturer’s Article 5(3) obligation to the user. Keep the risk-assessment period, maximum 7-calendar-day limit, no-additional-cost condition and at-delivery option intact. Agree logistics and cost allocation between commercial parties separately.²

Does a working EUDAMED link prove compliance?

No. It helps identify and retrieve the instructions. It does not prove the risk assessment, user boundary or paper service. Conversely, a missing record during a supported pre-mandatory-use registration transition is not alone proof of a breach. Establish the identifier and applicable date before deciding.¹⁹¹²

Must every translation be certified?

The cited eIFU provisions require the language determined by the relevant Member State; they do not impose a universal certified-translation label. Check destination requirements and the manufacturer’s controlled translation process. Certification can be a separately identified tender or contract requirement.²³

Can a professional near-patient IVD use the MDR extension?

No. The MDR implementing regulation does not govern IVDs. IVDR Annex I 20.1(f) excludes near-patient testing from its permission for professional-use non-paper instructions. Verify the IVD’s own instruction requirements rather than relying on Regulation (EU) 2025/1234.⁶