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Which address goes in the EUDAMED eIFU URL field?
The MDR marks the EUDAMED URL field optional. If your IFU is electronic, Article 7(3) of Regulation 2021/2226 makes it mandatory and names the address.
In the UDI-DI identification step in EUDAMED there is a line asking for a URL “if applicable” for additional information online. The help page does not say what kind of URL. The user guide has no field for electronic instructions at all. It is easy to leave the line empty, or to paste in the company homepage and move on.
If your instructions for use are electronic, neither is a good idea. The regulation that allows electronic instructions has a paragraph about this exact field. It makes the field mandatory and says which address belongs in it. It also expects that address to work for at least ten years after the last device is placed on the market. Let’s find out what it says, and whether a search page will do.
What the field is
The line on the form comes from the MDR’s list of data you file against every UDI-DI. Point 22 of that list reads “URL for additional information, such as electronic instructions for use (optional)” (Annex VI, Part B, point 22Annex VI, Part B, point 2222. URL for additional information, such as electronic instructions for use (optional),MDR · consolidated 2026-07-19. Consolidated text is a documentation tool with no legal effect.). The IVDR has the same line, with the same optional marking, at point 19 of its own list (Annex VI, Part B, point 19Annex VI, Part B, point 1919. URL for additional information, such as electronic instructions for use (optional),IVDR · consolidated 2025-01-10. Consolidated text is a documentation tool with no legal effect.).
So the field is wider than electronic instructions, which are only the example the drafters chose. And on its own, it is optional.
Why it stops being optional
Regulation (EU) 2021/2226 sets the conditions for supplying the instructions of an MDR device for professional users in electronic form instead of on paper. Since 16 July 2025 it has contained a sentence that ends (Article 7(3)Article 7(3)At the latest at the date from which the registration of devices in the UDI database referred to in Article 28 of Regulation (EU) 2017/745 applies in accordance with Article 123(3), point (d) or point (e), of that Regulation, as applicable, the manufacturer shall provide the internet address referred to in paragraph (2), point (e), of this Article to the UDI database in accordance with Part B, point 22, of Annex VI to Regulation (EU) 2017/745.eIFU Regulation · consolidated 2025-07-16. Consolidated text is a documentation tool with no legal effect.): ”… the manufacturer shall provide the internet address referred to in paragraph (2), point (e), of this Article to the UDI database in accordance with Part B, point 22, of Annex VI to Regulation (EU) 2017/745.”
The optional marking describes the field in general. Article 7(3) is a duty on you if your instructions replace paper. That includes instructions supplied on a storage medium, shown by the device itself, or provided through software, because in every case the instructions must also be available on your website (Article 5(11)Article 5(11)the instructions for use shall be available on their website in an official language of the Union determined by the Member State in which the device is made available;eIFU Regulation · consolidated 2025-07-16. Consolidated text is a documentation tool with no legal effect.).
For a manufacturer using electronic instructions, the optional field is a duty.
The duty exists only under the MDR. Regulation 2021/2226 does not apply to in vitro diagnostics. Their manufacturers may supply non-paper instructions for devices intended for professional use only, other than near-patient tests, under Annex I of the IVDR instead (Section 20.1(f)Annex I, Section 20.1(f)(f) When the device is intended for professional use only, instructions for use may be provided to the user in non-paper format (e.g. electronic), except when the device is intended for near-patient testing.IVDR · consolidated 2025-01-10. Consolidated text is a documentation tool with no legal effect.). Nothing on the IVD side requires filing an address, so point 19 stays optional in every case.
Which address
Article 7(3) does not ask for a link of your choosing. It points back to Article 7(2)(e), which points back to Article 6(2).
| Provision | What it says |
|---|---|
| Article 6(2)Article 6(2)Manufacturers shall provide information on how to access the instructions for use in electronic form.That information shall be provided as set out in the second subparagraph of paragraph 1 or, if not practicable, in a paper document supplied with each device.eIFU Regulation · consolidated 2025-07-16. Consolidated text is a documentation tool with no legal effect. | You give the user information on how to access the electronic instructions, on the packaging or, if that is not practicable, in a paper document with the device. |
| Article 7(2)(e)Article 7(2)(e)the internet address as displayed in accordance with Article 6(2) shall be stable and directly accessible during the periods set out in Article 5, points (9) and (10).eIFU Regulation · consolidated 2025-07-16. Consolidated text is a documentation tool with no legal effect. | The internet address displayed under Article 6(2) must be stable and directly accessible for the retention period. |
| Article 7(3) | That address is the one you file in point 22. |
The value of the field is therefore the address you give the user with the device. The same string sits on the packaging and in the UDI-DI record.
The address filed in EUDAMED is the one you give the user with the device.
For how long, and by when
The retention period is the one in Article 5. For devices with an expiry date, other than implants, the instructions stay available for 10 years after the last device was placed on the market. They also stay available for at least 2 years after the end of the expiry date of the last device produced (Article 5(9)Article 5(9)for devices with a defined expiry date, except implantable devices, they shall keep the instructions for use available for users in electronic form for 10 years after the last device has been placed on the market and at least 2 years after the end of the expiry date of the last produced device;eIFU Regulation · consolidated 2025-07-16. Consolidated text is a documentation tool with no legal effect.). For implants and for devices without an expiry date, it is 15 years after the last device was placed on the market (Article 5(10)Article 5(10)for devices without a defined expiry date and implantable devices, they shall keep the instructions for use available for the users in electronic form for 15 years after the last device has been placed on the market;eIFU Regulation · consolidated 2025-07-16. Consolidated text is a documentation tool with no legal effect.). The address has to survive every website redesign and domain change in that time. Once filed, it is public data that you must verify periodically and update within 30 days of a change (Annex VI, Part C, Sections 5.4Annex VI, Part C, Section 5.4Manufacturers shall periodically verify the correctness of all of the data relevant to devices they have placed on the market, except for devices that are no longer available on the market.MDR · consolidated 2026-07-19. Consolidated text is a documentation tool with no legal effect. and 5.8Annex VI, Part C, Section 5.8Manufacturers shall update the relevant UDI database record within 30 days of a change being made to an element, which does not require a new UDI-DI.MDR · consolidated 2026-07-19. Consolidated text is a documentation tool with no legal effect.).
The deadline follows the EUDAMED registration deadlines. The Commission’s notice that started the clock was published on 27 November 2025.
- Devices first placed on the market from 28 May 2026. You register before placing on the market (Article 29(1)Article 29(1)Before placing a device, other than a custom-made device, on the market, the manufacturer shall, in accordance with the rules of the issuing entity referred to in Article 27(2), assign a Basic UDI-DI as defined in Part C of Annex VI to the device and shall provide it to the UDI database together with the other core data elements referred to in Part B of Annex VI related to that device.MDR · consolidated 2026-07-19. Consolidated text is a documentation tool with no legal effect.), so the address is part of the record from day one (Article 123(3)(d)Article 123(3)(d)without prejudice to the obligations of the Commission pursuant to Article 34, the obligations and requirements that relate to any of the electronic systems referred to in Article 33(2) shall apply from the date corresponding to 6 months from the date of publication of the notice referred to in Article 34(3), informing that the relevant electronic system is functional and meets the functional specifications drawn up pursuant to Article 34(1). The provisions referred to in the preceding sentence are: — Article 29, — Article 31, — Article 32, — Article 33(4), — the second sentence of Article 40(2), — Article 42(10), — Article 43(2), — the second subparagraph of Article 44(12), — points (d) and (e) of Article 46(7), — Article 53(2), — Article 54(3), — Article 55(1), — Article 56(5), — Articles 70 to 77, — Article 78(1) to (13), without prejudice to Article 78(14), — Articles 79 to 82, — Article 86(2), — Articles 87 and 88, — Article 89(5) and (7), and the third subparagraph of Article 89(8), — Article 90, — Article 93(4), (7) and (8), — Article 95(2) and (4), — the last sentence of Article 97(2), — Article 99(4), — Article 120(3d). Until the date of application of the provisions referred to in the first subparagraph of this point, the corresponding provisions of Directives 90/385/EEC and 93/42/EEC regarding information on vigilance reporting, clinical investigations, registration of devices and economic operators, and certificate notifications shall continue to apply.MDR · consolidated 2026-07-19. Consolidated text is a documentation tool with no legal effect.).
- Devices already on the market before that date and still being placed on it. The registration data must be in by twelve months from the notice, that is 27 November 2026 (Article 123(3)(e)Article 123(3)(e)no later than 12 months from the date of publication of the notice referred to in Article 34(3) in respect of the electronic system referred to in Article 33(2), points (a) and (b), manufacturers shall ensure that the information to be entered in Eudamed in accordance with Article 29 is entered in that electronic system, including regarding the following devices, provided that those devices are also placed on the market from 6 months from the date of publication of that notice: (i) devices, other than custom-made devices, for which the manufacturer has undertaken a conformity assessment in accordance with Article 52; (ii) devices, other than custom-made devices, placed on the market pursuant to Article 120(3), (3a) or (3b), unless the device, for which the manufacturer has undertaken a conformity assessment in accordance with Article 52, is already registered in Eudamed;MDR · consolidated 2026-07-19. Consolidated text is a documentation tool with no legal effect.). The two dates differ by a day because the provisions are worded differently. The six-month rule says obligations apply from a date, while this one sets a deadline of no later than twelve months. Devices sold under the Article 120 transitional provisions are expressly included.
Can the address be a search page?
A manufacturer may print one address for the whole product range, with the user finding the right document on arrival by entering a UDI or a catalogue number. Whether that is “directly accessible” is not settled. The phrase dates from Regulation 207/2012, which applied from 1 March 2013. In thirteen years neither the Commission nor the MDCG has defined it, as far as we have found.
Our reading is that a search page is allowed, for three reasons. The adjectives in Article 7(2)(e) describe the address: it has to stay the same and it has to resolve. The access information you give the user must already include the Basic UDI-DI and/or the UDI-DI of the device (Article 6(3)Article 6(3)The information on how to access the instructions for use in electronic form shall also contain the following:(a) any information needed to view the instructions for use;(b) the Basic UDI-DI and/or the UDI-DI of the device, as respectively referred to in Article 27(6) and Article 27(1), point (a)(i), of Regulation (EU) 2017/745, and any additional information allowing the identification of the device, including its name and if applicable the model;(c) relevant manufacturer contact details e.g. manufacturer’s name, address, email address or other means of online communication and website;(d) where and how instructions for use in paper form can be requested and within which time they shall be obtained at no additional cost in conformity with Article 5, point (3).eIFU Regulation · consolidated 2025-07-16. Consolidated text is a documentation tool with no legal effect.). That requirement sits naturally with a user who uses the identifier on arrival. And nothing in the regulation limits the number of steps between the address and the document.
The other reading is that “directly accessible” describes the instructions, and a search page is a step in the way. It is a fair reading of the purpose. We do not take it, because the words do not say it.
Either way, the real test sits in Articles 4 and 5. Your risk assessment has to cover the users and their environment, and their familiarity with and access to the hardware and software needed to display the instructions. It also has to cover what happens when the website is temporarily unavailable (Article 4(1)Article 4(1)Manufacturers of devices referred to in Article 3, paragraphs 1 and 3, that provide instructions for use in electronic form to users instead of in paper form shall undertake a documented risk assessment which shall cover at least the following elements:(a) knowledge and experience of the intended users in particular regarding the use of the device and user needs;(b) characteristics of the environment in which the device will be used;(c) knowledge and experience of the intended user of the hardware and software needed to display the instructions for use in electronic form;(d) access of the user to the reasonably foreseeable electronic resources needed at the time of use;(e) performance of safeguards to ensure that the electronic data and content are protected from tampering;(f) safety and back-up mechanisms in the event of a hardware or software fault, particularly if the instructions for use in electronic form are integrated within the device;(g) foreseeable medical emergency situations requiring the provision of information in paper form;(h) impact caused by the temporary unavailability of the specific website or of the internet in general, or of their access in the healthcare institution as well as the safety measures available to cope with such a situation;(i) evaluation of the period within which the instructions for use shall be provided in paper form at the user’s request;(j) assessment of the website’s compatibility displaying the electronic instructions for use with different devices which could be used to display those instructions;(k) management of different versions of the instructions for use, where applicable in accordance with Article 5(8).eIFU Regulation · consolidated 2025-07-16. Consolidated text is a documentation tool with no legal effect.). You also have to provide verification and validation evidence that the electronic instructions are properly designed and function (Article 5(5)Article 5(5)they shall ensure the proper design and functioning of the instructions for use in electronic form and provide verification and validation evidence to this effect;eIFU Regulation · consolidated 2025-07-16. Consolidated text is a documentation tool with no legal effect.). A search page is a design choice, so it belongs in both. The question a notified body can put to you is simple: does a user in the real setting complete the search and reach the right version?
For comparison, the Australian TGA says an IFU available only online “must be easy to locate from the manufacturer’s homepage or a simple web search”, and should not sit behind an account or password. That is not EU law, but it shows a regulator thinking in terms of locating rather than landing.
A homepage with no route to the instructions fails on any reading. So, on our reading, does a login wall.
One address, three places
Article 7(3) names the address you display to the user. So you cannot, on our reading, print a generic address on the pack and then file a different, device-specific link in EUDAMED. The field takes the displayed address, and the search page then has to do the work.
The simplest arrangement removes the question. Give each device its own address. Then the packaging, the website and the EUDAMED record all point to the same place. Ydntfy offers both: a device-specific address for each device, and a search page for the generic case. You can build the same thing on your own site.
If your instructions are on paper
Then there is no Article 7(3) and the field is what the MDR says it is: optional. It can still be useful, and it still has consequences.
The best candidate for it is a page you already owe. Annex I requires the information supplied with the device to be available and kept up to date on your website, if you have one (Annex I, Section 23.1Annex I, Section 23.1General requirements regarding the information supplied by the manufacturerEach device shall be accompanied by the information needed to identify the device and its manufacturer, and by any safety and performance information relevant to the user, or any other person, as appropriate. Such information may appear on the device itself, on the packaging or in the instructions for use, and shall, if the manufacturer has a website, be made available and kept up to date on the website, taking into account the following:(a) The medium, format, content, legibility, and location of the label and instructions for use shall be appropriate to the particular device, its intended purpose and the technical knowledge, experience, education or training of the intended user(s). In particular, instructions for use shall be written in terms readily understood by the intended user and, where appropriate, supplemented with drawings and diagrams.(b) The information required on the label shall be provided on the device itself. If this is not practicable or appropriate, some or all of the information may appear on the packaging for each unit, and/or on the packaging of multiple devices.(c) Labels shall be provided in a human-readable format and may be supplemented by machine-readable information, such as radio-frequency identification (‘RFID’) or bar codes.(d) Instructions for use shall be provided together with devices. By way of exception, instructions for use shall not be required for class I and class IIa devices if such devices can be used safely without any such instructions and unless otherwise provided for elsewhere in this Section.(e) Where multiple devices are supplied to a single user and/or location, a single copy of the instructions for use may be provided if so agreed by the purchaser who in any case may request further copies to be provided free of charge.(f) Instructions for use may be provided to the user in non-paper format (e.g. electronic) to the extent, and only under the conditions, set out in Regulation (EU) No 207/2012 or in any subsequent implementing rules adopted pursuant to this Regulation.(g) Residual risks which are required to be communicated to the user and/or other person shall be included as limitations, contra-indications, precautions or warnings in the information supplied by the manufacturer.(h) Where appropriate, the information supplied by the manufacturer shall take the form of internationally recognised symbols. Any symbol or identification colour used shall conform to the harmonised standards or CS. In areas for which no harmonised standards or CS exist, the symbols and colours shall be described in the documentation supplied with the device.MDR · consolidated 2026-07-19. Consolidated text is a documentation tool with no legal effect.). A device page with the label and instruction content, data sheets and reprocessing instructions is a natural fit. Whatever you file becomes public (Article 28(3)Article 28(3)The core data elements to be provided to the UDI database, referred to in Part B of Annex VI, shall be accessible to the public free of charge.MDR · consolidated 2026-07-19. Consolidated text is a documentation tool with no legal effect.) and has to be kept correct, and the page it points at stays subject to the ban on misleading claims (Article 7Article 7In the labelling, instructions for use, making available, putting into service and advertising of devices, it shall be prohibited to use text, names, trade marks, pictures and figurative or other signs that may mislead the user or the patient with regard to the device's intended purpose, safety and performance by:(a) ascribing functions and properties to the device which the device does not have;(b) creating a false impression regarding treatment or diagnosis, functions or properties which the device does not have;(c) failing to inform the user or the patient of a likely risk associated with the use of the device in line with its intended purpose;(d) suggesting uses for the device other than those stated to form part of the intended purpose for which the conformity assessment was carried out.MDR · consolidated 2026-07-19. Consolidated text is a documentation tool with no legal effect.). We would keep campaign pages and tracking links out of it.
One last point, for manufacturers who put their paper instructions online as well. Those count as instructions in electronic form (Article 2(1)Article 2(1)‘instructions for use in electronic form’ means instructions for use displayed in electronic form by the device, contained in portable electronic storage media supplied by the manufacturer together with the device, or made available through a software or a website;eIFU Regulation · consolidated 2025-07-16. Consolidated text is a documentation tool with no legal effect.), but the conditions in Articles 3 to 7, including Article 7(3), apply only where the electronic form replaces paper. Since 16 July 2025 an online copy beside paper carries one requirement under this regulation: it must be consistent with the paper (Article 9Article 9Instructions for use in electronic form, which are provided in addition to complete instructions for use in paper form, shall be consistent with the content of the instructions for use in paper form.eIFU Regulation · consolidated 2025-07-16. Consolidated text is a documentation tool with no legal effect.). The paragraph that once applied some of the website conditions to it, including the stable address, was deleted. The paper still goes in the box, and the address of the online copy does not have to be filed anywhere.
Publishing the paper instructions online does not make them instructions supplied instead of paper.
Sources
Primary sources. Every claim in this post is traceable to one of these, and the sub-provision detail sits here rather than in the body.
Show 11 sources
- Commission Implementing Regulation (EU) 2021/2226 on electronic instructions for use, consolidated text of 16 July 2025: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02021R2226-20250716. Article 2(1), definition; Article 3(1), professional users; Article 4(1), points (a), (b), (c), (d), (h) and (j); Article 5, points (5), (9), (10), (11) and (13); Article 6(1), (2) and (3), points (a) and (b); Article 7(1), 7(2), points (c) and (e), and 7(3); Article 9.
- Commission Implementing Regulation (EU) 2021/2226 as first published, Official Journal L 448 of 15 December 2021, p. 32: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32021R2226. Article 9, second paragraph, since deleted: “Where such instructions for use are provided through a website, this website shall fulfil the requirements set out in Article 7(2), points (b), (d), (e) and (f).”
- Commission Implementing Regulation (EU) 2025/1234 amending Regulation 2021/2226, Official Journal of 26 June 2025, in force 16 July 2025: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32025R1234. Recital 3, transitional devices; Article 1, point (6)(a), deleting Article 7(2)(f); point (6)(b), inserting Article 7(3); point (8), deleting the second paragraph of Article 9.
- Commission Regulation (EU) No 207/2012 on electronic instructions for use of medical devices, repealed: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32012R0207. Article 7(2)(f), the origin of “stable and directly accessible”; Article 10, application from 1 March 2013.
- Regulation (EU) 2017/745 (MDR), consolidated text of 19 July 2026: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0745-20260719. Article 7, claims; Article 28(1), (2) and (3), UDI database; Article 29(1), registration before placing on the market; Article 123(3), points (d) and (e), application dates; Annex I, Section 23.1, information on the website; Annex VI, Part B, point 22; Annex VI, Part C, Sections 5.4 and 5.8.
- Regulation (EU) 2017/746 (IVDR), consolidated text of 10 January 2025: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110. Annex I, Section 20.1(f); Annex VI, Part B, point 19.
- Commission Decision (EU) 2025/2371 of 26 November 2025 on the notice regarding the functionality of certain EUDAMED electronic systems, Official Journal of 27 November 2025: https://eur-lex.europa.eu/eli/dec/2025/2371/oj. Article 1, the four systems confirmed functional.
- European Commission, “The EUDAMED four first modules will be mandatory to use as from 28 May 2026”, 27 November 2025: https://health.ec.europa.eu/latest-updates/eudamed-four-first-modules-will-be-mandatory-use-28-may-2026-2025-11-27_en
- EUDAMED help, UDI-DI identification information: https://webgate.ec.europa.eu/eudamed-help/en/actor/topics-by-actor/eu-manufacturer/register-a-basic-udi-di-together-with-a-udi-di-of-a-regulation-device/udi-di-identification-information.html
- EUDAMED, UDI Devices user guide, production: https://webgate.ec.europa.eu/eudamed-help/en/files/UDI%20Devices%20-%20user%20guide.pdf
- Therapeutic Goods Administration (Australia), Supplying electronic instructions for use (eIFU) for medical devices: https://www.tga.gov.au/resources/guidance/supplying-electronic-instructions-use-eifu-medical-devices. Section “IFUs exclusively available via a website”.
About this post
Ydntfy runs electronic instructions for use for medical device and IVD manufacturers, built to the conditions in Articles 4 to 7 of Regulation (EU) 2021/2226 for devices under the MDR and to Annex I, Section 20.1(f) of the IVDR for in vitro diagnostics. You can see how it works at ydntfy.com.
Originally published at https://ydntfy.com/en/blog/eudamed-eifu-url-field/ on 3 September 2026. You are welcome to quote or reuse this, with a link back.