One platform for the IFUs of every manufacturer you represent
Since July 2025, Implementing Regulation (EU) 2025/1234 opens electronic IFU to all professional-use devices, including the Annex XVI products. Idntfy puts the current IFU of each client under one account, tells you when a document changes, and pays a referral fee when a manufacturer you introduce becomes a customer.
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Until 2025, electronic IFU was limited to a short list of device categories. Implementing Regulation (EU) 2025/1234, in force since July 2025, extends it to every device intended for professional users, including the Annex XVI products without a medical purpose. Many of your clients became eligible overnight, and telling them so is a service in itself. The survey underlying the amendment is cited in recital (2) of the regulation.
The background to that changeWhat the platform does for your practice
Your duties as an Authorised Representative are evidential. You verify that the documentation has been drawn up, you keep it at the disposal of competent authorities, and you provide the information that demonstrates the conformity of a device.
MDCG 2022-16 advises you to verify that the necessary documentation has been drawn up and that it is accessible to you in its up-to-date versions, and it expects you to be able to demonstrate to a competent authority, through your own internal records, that those verifications were performed. For the IFU part of the file, the platform is built to make that position strong.
How the eIFU duties divide, article by article-
All your clients under one account
Each manufacturer you represent is a separate workspace, and one account reaches all of them. You move between clients from a single list: no second login, no asking anyone to email you the latest file.
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Notification when an IFU changes
Subscribe to the devices you want to watch, and an email tells you when a new version is published. Paper gives you no signal that a document changed; here the current version and its history are in front of you.
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The issued versions, with their publication dates
MDR Art. 11(3)(b), (d)Article 5(13) of the eIFU regulation requires every issued electronic version to remain available with its date of publication. The platform hosts the versions, so that record exists as operational fact rather than as a claim, ready to produce when a competent authority asks.
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Markets and language versions, held as data
eIFU Art. 5(11)Every issued version carries its countries and languages, and each device carries its market coverage. The catalogue names every product that is not live, and why: no current version, or none published to a country the device is sold in. It also counts the versions that archive within the next thirty days.
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Practical support for permanent availability
MDR Art. 10(8)The manufacturer must keep its documentation permanently available to you. Guidance reads that as constant availability through electronic or physical storage, either shared or otherwise. A shared platform is a working implementation of that duty for the IFU part of the file.
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A service that wins mandates
Non-EU manufacturers choose between AR firms that look alike on paper. Arriving with an eIFU arrangement already in place, and with the 2025 scope change explained, is a visible difference.
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A referral programme
When a manufacturer you introduce becomes an Idntfy customer at standard pricing, you receive a referral fee. We explain the terms in the intro meeting.
Our pricing, published openly
What your clients get
The general case for electronic instructions, in the four points the brochure below puts to them.
An IFU that is always current
Their customers open the approved, current version, never an outdated print. A correction goes live across every Member State at once, with the version history standing behind it.
Languages at scale
Each market can require its own language. A new market means publishing a file rather than planning a print run, and every language version sits against the same device.
Lighter packaging and logistics
No leaflet to insert, reprint or scrap. The carton is often sized around the folded leaflet, and the Packaging and Packaging Waste Regulation turns the space it occupies into a documented decision.
Per-country usage data
They see their IFUs being accessed per country: evidence of availability, and a market signal paper never gave them.
What the regulation says, and where it stops
Electronic IFU for professional-use devices is governed by Implementing Regulation (EU) 2021/2226 as amended by 2025/1234. The conditions that regulation places on the electronic system, including availability, previous versions and the information on where to obtain a paper copy, are handled by the platform.
Neither regulation mentions the Authorised Representative. Every eIFU obligation in them is addressed to the manufacturer, and nothing on this page is offered as a duty of yours. What the platform does is make the manufacturer's half of the file something you can see, and produce when you are asked for it.
Eligibility remains limited to devices intended for professional users; where lay use is reasonably foreseeable, those instructions stay on paper. This page is written for medical devices under the MDR; the rules for in vitro diagnostic medical devices differ.
Whether a specific device qualifies can be checked against the eligibility worksheet. The six gates, with the article behind each one
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An intro meeting, then a decision
In half an hour we show you the platform from the AR side, walk through the referral programme, and give you the client-facing material. If it does not fit your practice, you will know quickly.
Book an intro meeting