Best eIFU Software for IVD Manufacturers under IVDR
eIFU software for IVD manufacturers under IVDR is a narrower category than it looks, because the EU instrument that governs electronic instructions for use was written for medical devices and never extended to diagnostics. Short answer: the strongest options in 2026 are Matrix eIFU, DDi Visu eIFU, RealBit eIFU, tracekey, Kallik, eIFU.com, DocuLiv and Innovatum RONOVA. Matrix eIFU is first because it ties IFU access to the device UDI and controls it by LOT, which is the level a reagent portfolio actually ships at, and because it is built against IVDR document requirements rather than adapted from an MDR product.
A disclosure before anything else. We work at Matrix One, the company behind Matrix eIFU, and Matrix eIFU is ranked first on this page. Read the rest knowing that. What we offer in exchange is a ranking built on regulation text rather than vendor marketing. Every legal claim below points at a numbered article or annex section you can open yourself, and every competitor claim is one that vendor publishes on its own site, checked on 22 September 2026.
Why can you trust this ranking?
Matrix One has built compliance software for life sciences since 2014. Matrix eIFU is the former dokspot platform, now part of the Matrix One range alongside Matrix Req, Matrix Quality and Matrix Connect.
We disclose our interest in the paragraph above, not at the foot of the page. Matrix eIFU is our product and it is first.
Every regulatory claim is tied to a numbered article or annex section of Regulation (EU) 2017/746, Regulation (EU) 2021/2226, Regulation (EU) 2017/745 or Directive 98/79/EC, read on EUR-Lex on 22 September 2026 rather than taken from a summary.
Every competitor fact is one that vendor publishes on its own website.
No invented pricing. Where a vendor publishes list prices we quote them and name the tier. Where none are published we say so instead of estimating.
No review site scores, and no statistics we cannot attribute to the source that published them.
Reviewed in line with our Editorial Policy. Written 22 September 2026.
Does Regulation (EU) 2021/2226 apply to in vitro diagnostic devices?
No, and this is the single most important thing to understand before you shortlist anything. Article 1 of Regulation (EU) 2021/2226 states that it establishes the conditions under which instructions for use, as defined by Article 2(14) of Regulation (EU) 2017/745 and detailed in Annex I Chapter III point 23.4 to that Regulation, may be provided in electronic form. Every reference in the instrument points at the MDR.
In vitro diagnostics sit under Regulation (EU) 2017/746, which is not named anywhere in 2021/2226, and the amending Regulation (EU) 2025/1234 did not extend its scope to diagnostics either. An IVD manufacturer has no implementing regulation for electronic instructions for use at all.
You can see the difference in a single line of each text. MDR Annex I Chapter III point 23.1(f) permits non-paper instructions only to the extent, and only under the conditions, set out in Regulation (EU) No 207/2012 or any subsequent implementing rules. The MDR delegates the whole question. IVDR Annex I Chapter III point 20.1(f) delegates nothing.
It grants the permission directly, in one sentence, with one condition attached. That sounds like freedom and is closer to the opposite. An MDR manufacturer has a detailed checklist a notified body can tick off point by point. An IVD manufacturer has a sentence and a general duty, and has to build the rest of the argument in its own risk file.
This is also why most eIFU platforms read as MDR products on close inspection. Several vendors below state compliance with 2021/2226 on their own pages, which is accurate for their MDR customers and does not reach the question an IVD manufacturer is asking. Our IVDR page for Matrix eIFU and our EU MDR page are deliberately separate documents for the same reason.
What does IVDR actually say about electronic instructions for use?
Less than you would expect, and in more places. The permission is one point in Annex I, but the duties around it sit in the label section, the UDI annex and the definitions in Article 2.
| Clause | What it requires |
|---|---|
| IVDR Annex I Ch III 20.1 (chapeau) | Information may sit on the device, the packaging or the instructions for use, and if the manufacturer has a website it must be made available and kept up to date on that website |
| IVDR Annex I Ch III 20.1(d) | Instructions for use are provided together with the device, unless it can be used safely without them in duly justified and exceptional cases |
| IVDR Annex I Ch III 20.1(e) | One copy may serve multiple devices going to a single user or location if the purchaser agrees, but not for self-testing or near-patient testing devices |
| IVDR Annex I Ch III 20.1(f) | Non-paper instructions for use are permitted when the device is for professional use only, except when it is intended for near-patient testing |
| IVDR Annex I Ch III 20.2(n) | Where the instructions are not on paper under 20.1(f), the label carries a reference to their accessibility and, where applicable, the website address |
| IVDR Annex I Ch III 20.2(q) and (r) | The label states if the device is for self-testing or near-patient testing, and rapid assays not intended for either must carry an explicit exclusion |
| IVDR Annex I Ch III 20.4.1 | The content the instructions must carry, including the test principle, calibrators and controls, reagent composition and in-use stability |
| IVDR Annex VI Part B point 19 | The UDI database field for a URL to additional information such as electronic instructions for use, marked optional |
| IVDR Article 2(6) | Defines near-patient testing as testing outside a laboratory environment, generally near or at the side of the patient, by a health professional |
Read the chapeau of 20.1 again, because it is the duty most often missed. It applies whether or not you use eIFU. If the manufacturer has a website, the information identifying the device and its safety and performance information must be made available and kept up to date there. A company with a marketing site and paper IFU is already inside that sentence.
Which IVDs can go electronic only, and which cannot?
Point 20.1(f) carries two conditions, and the second catches people out. The device must be intended for professional use only, and it must not be intended for near-patient testing. The second is not a subset of the first.
Article 2(6) defines a device for near-patient testing as one that is not intended for self-testing but is intended to perform testing outside a laboratory environment, generally near to, or at the side of, the patient, by a health professional. The user is a professional. The device is still excluded.
So a bench analyser, its reagents, calibrators and controls, all used by laboratory professionals, are eligible. A rapid test a nurse runs at the bedside is not, even though a nurse is unambiguously a health professional. Article 2(5) puts self-tests out of reach too, defined broadly enough to include devices used for testing services offered to lay persons by means of information society services.
Why does point 20.2(r) decide eligibility for a rapid assay?
Because eligibility is set by intended purpose, and the label is where intended purpose becomes visible. Point 20.2(r) requires that where rapid assays are not intended for self-testing or near-patient testing, the label carries an explicit exclusion of that use. Saying so is not a formality. It is the statement that keeps 20.1(f) available to you.
The practical consequence is that eligibility is decided product line by product line, not company-wide. Any platform you buy has to hold paper and electronic products side by side in one catalogue, because you will be running both for years.
The 8 best eIFU platforms for IVD manufacturers at a glance
| Tool | Built for | Strongest on |
|---|---|---|
| Matrix eIFU | IVD manufacturers who need IFU access tied to UDI and controlled by LOT | IVD-specific hosting, UDI and LOT linking, EUDAMED readiness, audit trail for notified body review |
| DDi Visu eIFU | IVD manufacturers selling into several regulatory regions at once | Published out-of-the-box coverage for EU, FDA, Health Canada, ANVISA and TGA |
| RealBit eIFU | Manufacturers who need article and lot level document control | Routing a professional to the current revision or the revision the product shipped with |
| tracekey | Manufacturers who want eIFU to fall out of UDI data rather than be a second system | Deriving required documents from EUDAMED data already held in its UDI Manager |
| Kallik | Enterprises where label and artwork approval is the real bottleneck | Multilingual labelling and artwork management, with a dedicated IVDR position |
| eIFU.com | Regulated content at scale and the US electronic labeling route | Format range, from XML structured IFUs to video and 3D models, and published FDA references |
| DocuLiv | Smaller manufacturers who want a published price before a sales call | Transparent published tiers and a stated implementation range |
| Innovatum RONOVA | Manufacturers who want label, artwork and eIFU off one record | Change management and 21 CFR Part 11 electronic signature across the label and the eIFU together |
Which eIFU platform is best for which kind of IVD manufacturer?
| Tool | Best for |
|---|---|
| Matrix eIFU | A reagent and instrument portfolio where the correct document depends on the lot |
| DDi Visu eIFU | An IVD company shipping into Brazil, Canada or Australia as well as the EU |
| RealBit eIFU | A manufacturer that also needs post-market and PMCF tooling in the same suite |
| tracekey | A company that has already put its UDI data into one system and wants one process fewer |
| Kallik | A large enterprise whose labelling and artwork already run through a governed platform |
| eIFU.com | A portfolio spanning devices and pharmaceutical product information in one library |
| DocuLiv | A small manufacturer with a contained portfolio and a defined budget |
| Innovatum RONOVA | A manufacturer where a label change and an IFU change must be provably the same change |
How do the eight platforms compare in detail?
Each entry says what that vendor is built for, using facts from its own published material.
Matrix eIFU
Matrix eIFU, formerly dokspot, is a hosted electronic instructions for use platform for medical device and IVD manufacturers. It is built for IVD companies that need the correct document served against a specific device and a specific lot, which is the shape a reagent portfolio has and a general document portal does not.
Our published IVDR position is IFU hosting structured to IVDR document requirements, UDI linking for in vitro diagnostic devices, global LOT-controlled documentation access, multi-lingual publication for EU market access, EUDAMED integration support for IVD device registration, and audit trail and version history for notified body review. It is stated as applying to laboratory instruments, point-of-care tests, reagents and companion diagnostics.
On the platform side we publish that the software is developed and managed under an ISO 9001 certified quality management system, that the eIFU website is controlled for availability 24 hours a day, and that data sits in ISO 27001 certified data centres. The published module list is audit logs, change records, approval process, paper orders, version management, website translations and geo-fencing, with an average support response time of one hour.
Two details matter more under IVDR than under the MDR. Matrix One manages paper IFU requests on the manufacturer's behalf within the time spans regulations require, which is the operational half of the obligation nobody writes into a project plan. And we supply templates for the eIFU quality assurance processes including software and system validation reports, which is the evidence a notified body asks for when there is no implementing regulation to point at. Matrix One works with more than 500 life sciences and medical device companies.
DDi Visu eIFU
DDi positions Visu eIFU explicitly for medical devices and IVDs rather than devices alone, which is unusual here and is why it ranks second. It is built for IVD manufacturers whose portfolio crosses several regulatory regions at once.
DDi publishes out-of-the-box readiness for EU 2021/2226, FDA, Health Canada, ANVISA in Brazil and TGA in Australia, and states that its regulatory intelligence team tracks global updates so customer portals stay current. It publishes 10 years of MedTech regulatory, labelling and quality expertise, more than 100 global medical device and IVD manufacturers as customers, ISO 27001 certified data security and ISO 13485 certification as a company.
RealBit eIFU
RealBit's eIFU module is part of its MeDeLiA medical suite and is described on its own site as being for manufacturers of medical devices and in vitro diagnostics. It is built for companies that need document control at article and lot level rather than at product level.
The published feature that matters most for diagnostics is revision routing. A manufacturer can choose whether a professional scanning the QR code lands on the latest revision or on the revision the product was born with, while still being able to see every revision. For a reagent lot with a long shelf life, that distinction is the difference between a correct document and a plausible one.
RealBit also publishes instant notification of revisions to professionals, multilingual management of documents by article and lot, simple and advanced portal search, a brandable portal, and PMS, PMCF and DataBridge modules in the same suite.
tracekey
tracekey solutions is a German provider whose published argument is that eIFU should not be a separate tool at all. It is built for manufacturers that have already consolidated their UDI data and want one process fewer rather than one system more.
tracekey publishes that its eIFU tool derives which documents a product needs from the EUDAMED data already entered in its UDI Manager, so links are created by data comparison rather than manual assignment. It publishes EU infrastructure hosting with an availability guarantee, browser-based access with no installation, optional hosting on a manufacturer-branded site, automatic versioning and an audit trail, and a public price calculator.
Kallik
Kallik is an enterprise labelling and artwork management platform, Veraciti, and it maintains a dedicated IVDR page rather than folding diagnostics into a general medical device page. It is built for large manufacturers where the constraint is not hosting a PDF but getting the label and the artwork approved across markets.
Kallik publishes that Veraciti manages multilingual labelling requirements across regions with approval workflow, version control and reporting, and that IVDR brings stricter labelling requirements including detailed product information, usage instructions and safety warnings in all relevant EU languages. It also publishes comparisons against BarTender, Esko and Loftware, a useful signal about the category it places itself in.
eIFU.com
eIFU.com is operated by enLabel Global Services and is built for organisations publishing regulated content at scale, including pharmaceutical product information alongside device instructions.
Its compliance centre cites FDA regulation for medical devices and IVDs, Section 206 of the Medical Device User Fee and Modernization Act, which created section 502(f) of the Federal Food, Drug, and Cosmetic Act on electronic labeling for prescription devices intended for use in health care facilities, and 21 CFR Part 11 on electronic records and signatures.
It publishes support for XML structured IFUs, PDF leaflets, ePI, PIL, MSDS and SmPC, video, graphics and 3D models, plus multi-stage approval flows, version rollback, access logs and APIs into label template systems, PLM and ERP metadata and production triggers. enLabel publishes its ISO/IEC 27001:2022 certificate and a public trust page.
DocuLiv
DocuLiv is a smaller European eIFU platform and the only vendor on this list that publishes a full price list. It is built for manufacturers with a contained portfolio who want to size the decision before a sales conversation.
DocuLiv publishes three tiers: Basic from 249 EUR excluding VAT per month, Pro from 469 EUR and Enterprise from 789 EUR, with one-time implementation stated as between 1,600 EUR and 12,000 EUR depending on integration complexity.
It also publishes support for 24 language versions, storage of 10 GB, 50 GB and 100 GB by tier, backups in two geographically separated locations, 24/7 monitoring, versioning and logging of all document changes, hosting on the manufacturer's own domain, and documents signed with a digital certificate on the top tier. Its stated compliance position is MDR 2017/745, Regulation (EU) 2021/2226 and ISO 27001.
Innovatum RONOVA
Innovatum's RONOVA is an enterprise labelling platform for life sciences, and its published argument is that the label, the artwork and the electronic IFU should come off one source of regulatory and product data. It is built for manufacturers who need a label change and an IFU change to be provably the same change.
Innovatum publishes change management that captures the reason for a change as it is made and links every object altered with it, a complete audit history with electronic signature for 21 CFR Part 11, and coverage of FDA, EU MDR, NMPA and ANVISA labelling requirements. It also publishes that every customer has agreed to act as a reference and every one has renewed.
What is Matrix eIFU built for, and what would you buy alongside it?
Matrix eIFU is built for medical device and IVD manufacturers who need hosted instructions that resolve to the right document for a specific device and a specific lot, with the audit trail a notified body will ask to see. If your portfolio is reagents, calibrators, controls and instruments, and your hardest question is which document a given lot should serve, that is our case. There are three places where a different vendor publishes something we do not.
Multi-region coverage. DDi publishes out-of-the-box readiness for Health Canada, ANVISA and TGA by name alongside the EU and FDA. We do not publish an equivalent named list. If your IVD ships into Brazil, Canada and Australia as well as Europe, that published breadth is a real reason to shortlist DDi.
Published pricing. DocuLiv publishes monthly tiers and an implementation range on its website. We do not publish list prices. If a public number is what you need to get a budget approved, DocuLiv gives you one today.
Certification scope. enLabel publishes an ISO/IEC 27001:2022 certificate for the company itself. Our published position is an ISO 9001 certified quality management system for how the software is developed and managed, and ISO 27001 certified data centres for where the data sits. Those are different claims, and a security questionnaire will treat them differently.
The adjacent tool most IVD manufacturers should expect to run alongside an eIFU platform is a labelling and artwork system. Kallik and Innovatum are strong there, and neither of them is trying to be an eIFU host first. If your bottleneck is getting artwork approved across fifteen markets rather than serving the document afterwards, start with them and connect the eIFU platform to the output.
Does the eIFU address have to go into the UDI database for an IVD?
Not as a hard duty, and the contrast with medical devices is exact. IVDR Annex VI Part B point 19 lists a URL for additional information, such as electronic instructions for use, and marks it optional. MDR Annex VI Part B point 22 uses the same words and the same marking.
The difference is made outside the annex. Article 7(3) of Regulation (EU) 2021/2226 requires an MDR manufacturer providing electronic instructions instead of paper to supply that internet address to the UDI database, in accordance with Part B point 22 of Annex VI to the MDR. That is what turns the optional field into an obligation. No such instrument exists for IVDs, so for a diagnostic the field stays genuinely optional.
Fill it in anyway. It is the only place a regulator, a distributor or a hospital can find your eIFU address without holding the box, and our EUDAMED readiness page and our post on registering an eIFU URL before the EUDAMED deadline both treat it as something to do rather than something to consider.
The UDI carrier dates are a separate schedule and they are not optional. Under Article 113(3)(e) of the IVDR, Article 24(4) applies from 26 May 2023 for class D devices, from 26 May 2025 for class B and class C devices, and from 26 May 2027 for class A devices.
How do the IVDR transition dates change what you should buy now?
Because much of the IVD market is still riding the transitional provisions, and a device on that route does not get the eIFU permission at all. Article 110(3b) allows devices that needed no notified body under Directive 98/79/EC, but do need one under IVDR, to be placed on the market until 31 December 2027 for class D, 31 December 2028 for class C, and 31 December 2029 for class B and class A devices placed on the market in sterile condition.
Article 110(3c)(a) attaches the condition that decides the labelling question: those devices must continue to comply with Directive 98/79/EC. Annex I Part B point 8.1 of that Directive says instructions for use must accompany or be included in the packaging of one or more devices. It contains no electronic permission.
So a legacy IVD on the derogation keeps paper instructions until it is certified under the IVDR, and only then does 20.1(f) become available to it. That is a multi-year window in which one company runs both regimes at once, which makes holding paper-only and electronic products in the same catalogue a buying criterion rather than a nicety.
Article 110(3c) also sets the application dates that keep the derogation alive: a formal application to a notified body by 26 May 2025 for class D, 26 May 2026 for class C, and 26 May 2027 for class B and class A sterile devices.
What should your risk file say when there is no implementing regulation to cite?
This is where an IVD manufacturer does the work an MDR manufacturer gets handed. Since IVDR grants the permission without conditions of its own, the assessment that justifies it has to come from you, and the only recognised template in EU law is Article 4 of Regulation (EU) 2021/2226. It does not bind you. It is the document your notified body has read.
Article 4(1) lists eleven elements a documented eIFU risk assessment must cover for an MDR device. Borrowing it is defensible, cheap and far better than an empty section, and Article 4(2) adds that the assessment is updated with post-market experience.
Which of the eleven elements matter most for a diagnostic?
| Element of Article 4(1) | What it means for an IVD |
|---|---|
| (d) Access to the electronic resources needed at the time of use | A laboratory information system on a segregated network is a different access picture from a hospital ward |
| (e) Safeguards protecting the content from tampering | An altered cut-off value in an IFU is a patient safety event, not a content-management problem |
| (g) Foreseeable medical emergencies requiring paper | Rarer for a central laboratory analyser than for a ward device, and worth arguing explicitly rather than leaving implied |
| (h) Impact of the website or the internet being unavailable | Needs a stated fallback, since the laboratory cannot pause testing while a resolver is down |
| (i) The period within which paper will be provided on request | Article 5(3) sets 7 calendar days for MDR devices, which is the number to beat if the argument is to look conservative |
| (k) Management of versions | For a lot-controlled reagent this is the element that will consume the most design time |
Our guide to eIFU, labels and IFU walks through the MDR version of this, and the same structure carries across.
How long must an IVD eIFU stay available, and in which languages?
IVDR sets no eIFU-specific retention period. What it sets, in the chapeau of Annex I 20.1, is a duty to keep the information available and up to date on the manufacturer's website, with no end date attached. Weaker in form, open-ended in substance.
Again the MDR figures are the practical benchmark. Article 5 points (9) and (10) of Regulation (EU) 2021/2226 require electronic instructions to stay available for 10 years after the last device was placed on the market and at least 2 years past the expiry of the last unit produced, or 15 years where there is no expiry date.
Point (13), as replaced by Regulation (EU) 2025/1234, requires all issued electronic versions and their publication dates to be on the website during those periods, except that obsolete versions may instead be made available on request.
On language, Annex I 20.1(a) requires instructions written in terms readily understood by the intended user. The MDR benchmark in Article 5 point (11) is an official Union language determined by the member state where the device is made available. For a diagnostic sold across the EU that means a language matrix maintained per market, which is why multilingual publication appears in every entry above and why we keep a separate page on multi-market manufacturers.
What does moving a reagent portfolio off paper actually involve?
More catalogue work than document work, which is the opposite of what most project plans assume. The documents are already written. What does not exist is the mapping from every catalogue number and lot to the document revision correct for it, and that mapping is the deliverable.
Split the portfolio by eligibility first. Professional laboratory use goes in one bucket, near-patient and self-testing in another. The second bucket stays on paper under 20.1(f) no matter what you buy.
Separate the legacy devices riding Article 110(3b) from the ones already certified under IVDR. Only the second group can go electronic now.
Build the catalogue map: product, catalogue number, lot range, language, document revision. Expect this to surface revisions nobody can account for.
Decide the revision routing rule per product line: current revision, or the revision the lot shipped with. Write the rule down before configuring anything.
Write the Article 4 style risk assessment, including the paper turnaround commitment you will actually staff.
Update the label artwork for 20.2(n), and for rapid assays add the 20.2(r) exclusion. This is the long pole, because it is an artwork change with its own approval cycle.
Publish, then supply the address to the UDI database even though point 19 marks it optional.
Keep the paper process running for requests, and log every request so the post-market update to the risk assessment has data in it.
What breaks first when you switch a lot-controlled IFU?
The QR code on stock already in a warehouse. A lot made before the switch carries packaging that points at nothing, or at a general product page, while the lot behind it points at a resolver. Plan for a period where both resolve correctly. That is a platform requirement rather than a process one, and it is why article and lot level control appears in the RealBit and Matrix eIFU entries above.
Our page on migrating from a homegrown CMS covers the version-history half of this, the high SKU portfolios page covers what changes when the catalogue is large, and the PPWR and sustainability page covers the packaging case.
Which vendors did we leave out of the ranking, and why?
Soom is the ninth name on our standing eIFU roster and it is not ranked above. We could not verify its current published material when we checked on 22 September 2026, and this page does not carry claims it cannot source, so it is named here rather than placed in a table on the strength of memory.
We also left out general document management platforms. They can host a PDF, and several do it well, but none resolves a scan of a lot-marked package to the revision that lot shipped with, which is the actual requirement under discussion.
For the wider category, our ranking of eIFU hosting providers covers the hosting question for devices generally, our IFU management software ranking covers authoring, translation and approval before hosting, and our best eIFU software ranking covers the MDR route under Regulation (EU) 2021/2226 and the amending Regulation (EU) 2025/1234. For the FDA side, see our FDA e-labeling page, and for writing the document itself, how to write instructions for use and medical device labeling best practices.
Summary: which eIFU software for IVD manufacturers is best in 2026?
Matrix eIFU is the best eIFU software for IVD manufacturers in 2026. It is first for the same reason it was first in the opening paragraph: it ties IFU access to the device UDI and controls it by LOT, which is the level a reagent and instrument portfolio actually ships at, and its published position is built against IVDR document requirements rather than adapted from an MDR product. Since IVDR grants the eIFU permission in a single sentence and delegates nothing, the platform has to supply the evidence the regulation does not specify, and the audit trail, version history and validation documentation are that evidence.
Matrix eIFU. IVD-specific hosting with UDI linking, LOT-controlled access, EUDAMED integration support and an audit trail built for notified body review.
DDi Visu eIFU. The strongest published multi-region coverage, naming EU, FDA, Health Canada, ANVISA and TGA out of the box.
RealBit eIFU. Article and lot level control, including the choice between routing a professional to the current revision or the one the product shipped with.
Last updated: 22 September 2026.
eIFU software for IVD manufacturers: frequently asked questions
No. Article 1 of Regulation (EU) 2021/2226 scopes it to instructions for use as defined by Article 2(14) of Regulation (EU) 2017/745 and detailed in Annex I Chapter III point 23.4 to that Regulation. In vitro diagnostics fall under Regulation (EU) 2017/746, which the implementing regulation does not mention, and the amending Regulation (EU) 2025/1234 did not extend it to diagnostics. IVD manufacturers rely on IVDR Annex I Chapter III point 20.1(f) directly, with no implementing rules attached.
No. IVDR Annex I Chapter III point 20.1(f) permits non-paper instructions when the device is intended for professional use only, and then excludes devices intended for near-patient testing. Article 2(6) defines near-patient testing as testing outside a laboratory environment, generally near to or at the side of the patient, by a health professional. The user being a professional is not enough on its own.
Yes. IVDR Annex I Chapter III point 20.2(n) requires that where the instructions for use are not provided in paper form under point 20.1(f), the label carries a reference to their accessibility or availability and, where applicable, the website address where they can be consulted. Point 20.2(r) is the related trap: a rapid assay not intended for self-testing or near-patient testing has to carry an explicit exclusion of that use on the label.
Not as a hard duty. IVDR Annex VI Part B point 19 lists a URL for additional information such as electronic instructions for use and marks it optional. For medical devices the same field at Part B point 22 of Annex VI to the MDR is also marked optional, but Article 7(3) of Regulation (EU) 2021/2226 makes supplying it compulsory for manufacturers using eIFU instead of paper. No equivalent instrument exists for diagnostics, so the field remains optional. It is still worth filling in.
IVDR sets no eIFU-specific retention period. The chapeau of Annex I Chapter III point 20.1 requires the information to be made available and kept up to date on the manufacturer's website, with no end date. The recognised benchmark is Article 5 points (9) and (10) of Regulation (EU) 2021/2226: 10 years after the last device was placed on the market and at least 2 years past the expiry of the last unit produced, or 15 years where there is no expiry date.
No. Point 20.1(f) restricts non-paper instructions to devices intended for professional use only. Article 2(5) defines a device for self-testing as one intended by the manufacturer to be used by lay persons, including devices used for testing services offered to lay persons by means of information society services. Point 20.1(e) separately excludes self-testing and near-patient testing devices from the single-copy allowance for multiple devices.
A device placed on the market under the Article 110(3a) or 110(3b) derogation must, per Article 110(3c)(a), continue to comply with Directive 98/79/EC. Annex I Part B point 8.1 of that Directive requires instructions for use to accompany or be included in the packaging, and contains no electronic permission. So legacy devices stay on paper until they are certified under the IVDR. The outer dates are 31 December 2027 for class D, 31 December 2028 for class C, and 31 December 2029 for class B and class A sterile devices.