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eIFU is now open to every professional-use device
In June 2025 the EU widened electronic instructions for use from three device types to all professional use. What changed, and what quietly got easier.
Most manufacturers we speak to are still working from the old rule. It is an easy mistake to make. The change arrived as an implementing regulation amending another implementing regulation, in June, with no transition period and no notified body announcement.
Commission Implementing Regulation (EU) 2025/1234 was adopted on 25 June 2025. It entered into force twenty days after publication. It amends Implementing Regulation (EU) 2021/2226, which is the rule that decides when instructions for use may be electronic instead of paper.
The effect is easy to state. eIFU used to be open to three device types. It is now open to professional use as a category.
The old scope
Article 3(1) of Regulation (EU) 2021/2226 originally listed three:
- implantable and active implantable medical devices and their accessories
- fixed installed medical devices and their accessories
- medical devices and their accessories fitted with a built-in system visually displaying the instructions
There were two conditions on top of the device type (Article 3(2)). The devices had to be intended for exclusive use by professional users, and use by other persons had to be not reasonably foreseeable.
So a surgical instrument, a reprocessing accessory or a bench analyser without a screen got the same answer. No. Not for any safety reason. It was not on the list.
Software sat beside the list with its own route. Article 3(3)Article 3(3)For software covered by Regulation (EU) 2017/745, manufacturers may provide instructions for use in electronic form by means of the software itself instead of in paper form.eIFU Regulation · consolidated 2025-07-16. Consolidated text is a documentation tool with no legal effect. lets manufacturers of software covered by the MDR provide the instructions through the software itself. That paragraph is about the delivery mechanism, not about who uses the device. The June 2025 amendment left it untouched.
If you remember software as one of the listed categories, you are thinking of the rule before this one. Regulation (EU) No 207/2012 listed “stand-alone software covered by Directive 93/42/EEC” as a category in its own right, at Article 3(1)(e). Regulation (EU) 2021/2226 dropped that term and moved software to its own paragraph. Small piece of drafting history, still a regular source of confusion in eligibility reviews.
The new scope
The replacement Article 3(1)Article 3(1)Manufacturers may provide instructions for use in electronic form instead of in paper form where those instructions relate to devices referred to in Article 1(4) of Regulation (EU) 2017/745 intended for use by professional users.eIFU Regulation · consolidated 2025-07-16. Consolidated text is a documentation tool with no legal effect. drops the list entirely. Manufacturers may now provide instructions in electronic form for devices referred to in Article 1(4) of the MDR that are intended for use by professional users.
That cross-reference does a lot of work. Article 1(4)Article 1(4)For the purposes of this Regulation, medical devices, accessories for medical devices, and products listed in Annex XVI to which this Regulation applies pursuant to paragraph 2 shall hereinafter be referred to as ‘devices’.MDR · consolidated 2026-07-19. Consolidated text is a documentation tool with no legal effect. of Regulation (EU) 2017/745 defines “devices” as medical devices, accessories for medical devices, and the products listed in Annex XVIAnnex XVI1. Contact lenses or other items intended to be introduced into or onto the eye.2. Products intended to be totally or partially introduced into the human body through surgically invasive means for the purpose of modifying the anatomy or fixation of body parts with the exception of tattooing products and piercings.3. Substances, combinations of substances, or items intended to be used for facial or other dermal or mucous membrane filling by subcutaneous, submucous or intradermal injection or other introduction, excluding those for tattooing.4. Equipment intended to be used to reduce, remove or destroy adipose tissue, such as equipment for liposuction, lipolysis or lipoplasty.5. High intensity electromagnetic radiation (e.g. infra-red, visible light and ultra-violet) emitting equipment intended for use on the human body, including coherent and non-coherent sources, monochromatic and broad spectrum, such as lasers and intense pulsed light equipment, for skin resurfacing, tattoo or hair removal or other skin treatment.6. Equipment intended for brain stimulation that apply electrical currents or magnetic or electromagnetic fields that penetrate the cranium to modify neuronal activity in the brain.MDR · consolidated 2026-07-19. Consolidated text is a documentation tool with no legal effect.. So accessories are in. Annex XVI products, which have no intended medical purpose, are in where they are for professional use (recital 4).
Recital 3 adds one more group that matters commercially. The extended scope covers devices under the transitional provisions of Article 120Article 1201. From 26 May 2021, any publication of a notification in respect of a notified body in accordance with Directives 90/385/EEC and 93/42/EEC shall become void.2. Certificates issued by notified bodies in accordance with Directives 90/385/EEC and 93/42/EEC prior to 25 May 2017 shall remain valid until the end of the period indicated on the certificate, except for certificates issued in accordance with Annex 4 to Directive 90/385/EEC or Annex IV to Directive 93/42/EEC which shall become void at the latest on 27 May 2022.Certificates issued by notified bodies in accordance with Directives 90/385/EEC and 93/42/EEC from 25 May 2017 that were still valid on 26 May 2021 and that have not been withdrawn afterwards shall remain valid after the end of the period indicated on the certificate until the date set out in paragraph 3a of this Article applicable for the relevant risk class of the devices. Certificates issued by notified bodies in accordance with those Directives from 25 May 2017 that were still valid on 26 May 2021 and that have expired before 20 March 2023 shall be considered to be valid until the dates set out in paragraph 3a of this Article only if one of the following conditions is fulfilled:(a) before the date of expiry of the certificate, the manufacturer and a notified body have signed a written agreement in accordance with Section 4.3, second subparagraph, of Annex VII to this Regulation for the conformity assessment in respect of the device covered by the expired certificate or in respect of a device intended to substitute that device;(b) a competent authority of a Member State has granted a derogation from the applicable conformity assessment procedure in accordance with Article 59(1) of this Regulation or has required the manufacturer, in accordance with Article 97(1) of this Regulation, to carry out the applicable conformity assessment procedure.3. By way of derogation from Article 5 and provided the conditions set out in paragraph 3c of this Article are met, devices referred to in paragraphs 3a and 3b of this Article may be placed on the market or put into service until the dates set out in those paragraphs.No later than 26 September 2024, the notified body that has signed the written agreement referred to in paragraph 3c, point (e), of this Article shall be responsible for the surveillance in respect of the devices covered by the written agreement. Where the written agreement covers a device intended to substitute a device which has a certificate that was issued in accordance with Directive 90/385/EEC or Directive 93/42/EEC, the surveillance shall be conducted in respect of the device that is being substituted.The arrangements for the transfer of the surveillance from the notified body that issued the certificate to the notified body designated in accordance with Article 42 shall be clearly defined in an agreement between the manufacturer and the notified body designated in accordance with Article 42 and, where practicable, the notified body that issued the certificate. The notified body designated in accordance with Article 42 shall not be responsible for conformity assessment activities carried out by the notified body that issued the certificate.3a. Devices which have a certificate that was issued in accordance with Directive 90/385/EEC or Directive 93/42/EEC and that is valid by virtue of paragraph 2 of this Article may be placed on the market or put into service until the following dates:(a) 31 December 2027, for all class III devices, and for class IIb implantable devices except sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors;(b) 31 December 2028, for class IIb devices other than those covered by point (a) of this paragraph, for class IIa devices, and for class I devices placed on the market in sterile condition or having a measuring function.3b. Devices for which the conformity assessment procedure pursuant to Directive 93/42/EEC did not require the involvement of a notified body, for which the declaration of conformity was drawn up prior to 26 May 2021 and for which the conformity assessment procedure pursuant to this Regulation requires the involvement of a notified body, may be placed on the market or put into service until 31 December 2028.3c. Devices referred to in paragraphs 3a and 3b of this Article may be placed on the market or put into service until the dates referred to in those paragraphs only if the following conditions are met:(a) those devices continue to comply with Directive 90/385/EEC or Directive 93/42/EEC, as applicable;(b) there are no significant changes in the design and intended purpose;(c) the devices do not present an unacceptable risk to the health or safety of patients, users or other persons, or to other aspects of the protection of public health;(d) no later than 26 May 2024, the manufacturer has put in place a quality management system in accordance with Article 10(9);(e) no later than 26 May 2024, the manufacturer or the authorised representative has lodged a formal application with a notified body in accordance with Section 4.3, first subparagraph, of Annex VII for conformity assessment in respect of a device referred to in paragraph 3a or 3b of this Article or in respect of a device intended to substitute that device, and, no later than 26 September 2024, the notified body and the manufacturer have signed a written agreement in accordance with Section 4.3, second subparagraph, of Annex VII.3d. By way of derogation from paragraph 3 of this Article, the requirements of this Regulation relating to post-market surveillance, market surveillance, vigilance, registration of economic operators and of devices shall apply to devices referred to in paragraphs 3a and 3b of this Article in place of the corresponding requirements in Directives 90/385/EEC and 93/42/EEC.3e. Without prejudice to Chapter IV and paragraph 1 of this Article, the notified body that issued the certificate referred to in paragraph 3a of this Article shall continue to be responsible for the appropriate surveillance in respect of the applicable requirements relating to the devices it has certified, unless the manufacturer has agreed with a notified body designated in accordance with Article 42 that the latter shall carry out such surveillance.3f. By way of derogation from Article 5, class III custom-made implantable devices may be placed on the market or put into service until 26 May 2026 without a certificate issued by a notified body in accordance with the conformity assessment procedure referred to in Article 52(8), second subparagraph, provided that no later than 26 May 2024, the manufacturer or the authorised representative has lodged a formal application with a notified body in accordance with Section 4.3, first subparagraph, of Annex VII for conformity assessment, and, no later than 26 September 2024, the notified body and the manufacturer have signed a written agreement in accordance with Section 4.3, second subparagraph, of Annex VII.4. Devices lawfully placed on the market pursuant to Directives 90/385/EEC and 93/42/EEC prior to 26 May 2021, and devices lawfully placed on the market from 26 May 2021 pursuant to paragraphs 3, 3a, 3b and 3f of this Article, may continue to be made available on the market or put into service.5. By way of derogation from Directives 90/385/EEC and 93/42/EEC, devices which comply with this Regulation may be placed on the market prior to 26 May 2021.6. By way of derogation from Directives 90/385/EEC and 93/42/EEC, conformity assessment bodies which comply with this Regulation may be designated and notified prior to 26 May 2021. Notified bodies which are designated and notified in accordance with this Regulation may carry out the conformity assessment procedures laid down in this Regulation and issue certificates in accordance with this Regulation prior to 26 May 2021.7. As regards devices subject to the consultation procedure laid down in Article 54, paragraph 5 of this Article shall apply provided that the necessary appointments to the MDCG and expert panels have been made.9. Authorisations granted by the competent authorities of the Member States in accordance with Article 9(9) of Directive 90/385/EEC or Article 11(13) of Directive 93/42/EEC shall keep the validity indicated in the authorisation.10. Devices falling within the scope of this Regulation in accordance with point (g) of Article 1(6) which have been legally placed on the market or put into service in accordance with the rules in force in the Member States prior to 26 May 2021 may continue to be placed on the market and put into service in the Member States concerned.11. Clinical investigations which have started to be conducted in accordance with Article 10 of Directive 90/385/EEC or Article 15 of Directive 93/42/EEC prior to 26 May 2021 may continue to be conducted. As of 26 May 2021, however, the reporting of serious adverse events and device deficiencies shall be carried out in accordance with this Regulation.12. Until the Commission has designated, pursuant to Article 27(2), issuing entities, GS1, HIBCC and ICCBBA shall be considered to be designated issuing entities.13. Article 10a shall also apply to devices referred to in paragraphs 3a and 3b of this Article.MDR · consolidated 2026-07-19. Consolidated text is a documentation tool with no legal effect. of the MDR. Legacy devices still running on a certificate under the old directives are not shut out.
For most manufacturers with a professional-use portfolio, the eligibility question has changed. It used to be “is my device type on the list”. It is now “is this device used only by professionals”.
The lay-person limit changed shape
Paper has not gone away for lay users. The replacement Article 3(2)Article 3(2)Where it is reasonably foreseeable that a device intended for use by professional users is also used by lay persons, manufacturers shall provide the instructions for use intended for lay persons in paper form.eIFU Regulation · consolidated 2025-07-16. Consolidated text is a documentation tool with no legal effect. reads: where it is reasonably foreseeable that a device intended for use by professional users is also used by lay persons, manufacturers shall provide the instructions for use intended for lay persons in paper form.
Compare that with what it replaced, because the shape is different.
The old Article 3(2) worked as a gate on the device. Exclusive professional use was required, and other use had to be not reasonably foreseeable. Fail either limb and the device was out of eIFU altogether.
The new paragraph works on the instructions instead. Foreseeable lay use means the instructions intended for lay persons go on paper. On the face of the text it does not shut the device out.
Take an infusion pump. It is normally nurse-operated, but it sometimes goes home with a patient. Under the old rule, that foreseeable home use disqualified the pump. Every instruction for that device went on paper, including the clinical ones your hospital users read. Under the new wording the pump stays eligible. What you owe on paper is the instructions written for the patient. The instructions written for the nurse can be electronic.
One practical limit is worth naming. This only helps where separate instructions for the two audiences actually exist. If a single combined IFU serves nurses and patients alike, there is nothing to separate, and you are realistically printing the whole document. The change rewards manufacturers who write for the two audiences separately.
A related deletion points the same way. The old Article 6(4) said that for implantables and their accessories, any part of the instructions intended for the patient could not be provided electronically. Regulation (EU) 2025/1234 deletes that paragraph. The patient-facing carve-out is now handled by the general lay-person rule in Article 3(2)Article 3(2)Where it is reasonably foreseeable that a device intended for use by professional users is also used by lay persons, manufacturers shall provide the instructions for use intended for lay persons in paper form.eIFU Regulation · consolidated 2025-07-16. Consolidated text is a documentation tool with no legal effect..
This is a meaningful shift for mixed-use portfolios. It is also recent, so we would want it recorded in a risk assessment and raised with your notified body, rather than assumed in a meeting.
What did not change: the conditions
The scope moved. The obligations did not. They sit in Articles 4 to 7 of Regulation (EU) 2021/2226, and they are the part that takes real work.
A documented risk assessment (Article 4Article 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).(2) The risk assessment for the provision of the instructions for use in electronic form shall be updated in view of the experience gained in the post-marketing phase.eIFU Regulation · consolidated 2025-07-16. Consolidated text is a documentation tool with no legal effect.). It has to demonstrate that electronic instructions maintain or improve the level of safety compared with paper (Article 5(1)Article 5(1)the risk assessment referred to in Article 4 shall demonstrate that providing instructions for use in electronic form maintains or improves the level of safety obtained by providing the instructions for use in paper form;eIFU Regulation · consolidated 2025-07-16. Consolidated text is a documentation tool with no legal effect.).
Paper on request (Article 5(3)Article 5(3)they shall have a system in place to provide the instructions for use in paper form at no additional cost for the user, within the time period set out in the risk assessment referred to in Article 4 and at the latest within 7 calendar days of receiving a request from the user or at the time of delivery of the device if so requested at the time of order;eIFU Regulation · consolidated 2025-07-16. Consolidated text is a documentation tool with no legal effect.). You need a system that delivers paper instructions at no additional cost to the user. The deadline is the period set in your risk assessment, and at the latest 7 calendar days from the request. If the user asks at the time of order, it goes out with the device. eIFU does not remove paper. It turns a print run into a service.
Retention (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. and (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.). Take devices with a defined expiry date, implantables aside. 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 expiry date of the last device produced. For implantables and for devices with no defined expiry date, it is 15 years after the last device was placed on the market.
Language (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.). The instructions have to be on your website in an official EU language determined by the Member State where the device is made available.
Information on the label, and how to reach the instructions (Article 6Article 6(1) Manufacturers shall clearly indicate on the label that the instructions for use of the device are supplied in electronic form instead of in paper form.That information shall be provided on the packaging for each unit or, where appropriate, on the sales packaging. In the case of fixed installed devices, that information shall also be provided on the device itself.In the case of software, the information shall be provided at the location from where access to the software is granted.(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.(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).(5) The instructions for use in electronic form shall be available entirely as text, which may contain symbols and graphics, with at least the same information as the instructions for use in paper form. Video or audio files may be provided in addition to the text.eIFU Regulation · consolidated 2025-07-16. Consolidated text is a documentation tool with no legal effect.). The label states that the instructions are supplied electronically instead of on paper. Separately, you provide the access information: what is needed to view the instructions, the Basic UDI-DI and/or the UDI-DI, manufacturer contact details, and where, how and within what time a paper copy can be requested.
Worth being precise about that identifier, because it comes up often. Article 6(3)(b)Article 6(3)(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;eIFU Regulation · consolidated 2025-07-16. Consolidated text is a documentation tool with no legal effect. names the Basic UDI-DI and/or the UDI-DI. A catalogue or REF number does not satisfy it. The same point does allow “any additional information allowing the identification of the device, including its name and if applicable the model”, which is where a REF belongs. So a REF alongside the UDI identifier, not instead of it. The access information itself goes on the unit or sales packaging, or in a paper document supplied with each device where that is not practicable (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.).
A website that behaves (Article 7(2)Article 7(2)Any website containing instructions for use of a device which are provided in electronic form instead of in paper form shall comply with the following requirements:(a) the instructions for use shall be provided in a commonly used format that can be read with freely available software;(b) it shall be protected against unauthorised access and tampering of content in accordance with Article 4(1), point (e);(c) it shall be provided in such a way that the server downtime and display errors are reduced as far as possible;(d) it shall fulfil the requirements of Regulation (EU) 2016/679;(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.). A commonly used format that opens with freely available software. Protection against unauthorised access and tampering. Server downtime and display errors reduced as far as possible. GDPR compliance. And an internet address that is stable and directly accessible for the whole retention period.
Regulation (EU) 2025/1234 adds one obligation. The manufacturer has to give that internet address to the UDI database, at the latest from the date device registration applies (new 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.). Your eIFU address is registered regulatory data now, not a marketing URL you can quietly change.
Two things the amendment quietly made easier
Not everything got heavier in June 2025.
The old Article 5(13) required every historical electronic version to be available on the website. The replacement is softer. During the retention periods, all issued versions and their publication dates must be available on the website, or, for obsolete versions, made available on request.
The old Article 5(12) required systems ensuring that users who had downloaded instructions could be informed about updates and corrective actions. That point is deleted. Article 5(8)Article 5(8)they shall have a system in place to clearly indicate when the instructions for use have been revised and to inform each user of the device thereof if the revision was necessary for safety reasons;eIFU Regulation · consolidated 2025-07-16. Consolidated text is a documentation tool with no legal effect. survives, so you still need a system that flags when instructions have been revised and informs each user when the revision was made for safety reasons.
Article 8 also went. It required a notified body to review compliance with Articles 4 to 7 during conformity assessment. The Commission removed it as redundant, since that review already forms part of conformity assessment under the MDR (recital 7). The scrutiny has not gone anywhere. The duplicate sentence has.
One caveat before you reuse any of this. Regulation (EU) 2021/2226 applies under the MDR. In vitro diagnostics follow a different route, and the conditions are not identical. We will take that apart in a later post.
Qualifying is not the same as being obliged
Nothing here requires you to move to eIFU. Regulation (EU) 2025/1234 makes electronic instructions available for professional-use devices. It does not make them mandatory, and the paper-on-request duty is untouched.
That distinction matters more than it sounds. We regularly meet regulatory teams who read a headline about the change and concluded a project had landed on their desk. It has not. What they have gained is permission, not an obligation. Ask the same eligibility question about the same device before July 2025 and the answer would have been no.
What to do with this
Three things are worth an hour of someone’s time this month.
- Re-run the eligibility question across the portfolio, gate by gate. Our eIFU eligibility decision tree sets out the six questions in the order they are worth answering, with the article behind each one. If you checked before July 2025 and the answer was no, that answer may be out of date. Include accessories, Annex XVI products and legacy devices under Article 120.
- Separate the devices that are professional use only from the ones a lay person might foreseeably use. The second group is not excluded any more, but it needs a documented position.
- Read Article 7(2)Article 7(2)Any website containing instructions for use of a device which are provided in electronic form instead of in paper form shall comply with the following requirements:(a) the instructions for use shall be provided in a commonly used format that can be read with freely available software;(b) it shall be protected against unauthorised access and tampering of content in accordance with Article 4(1), point (e);(c) it shall be provided in such a way that the server downtime and display errors are reduced as far as possible;(d) it shall fulfil the requirements of Regulation (EU) 2016/679;(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. before you evaluate any solution, including ours. A stable address that stays reachable for 15 years is the requirement that quietly rules out a PDF on a marketing site.
Sources
Primary sources. Every claim in this post is traceable to one of these.
Show 4 sources · 3 references
- Commission Implementing Regulation (EU) 2025/1234 of 25 June 2025 amending Implementing Regulation (EU) 2021/2226 as regards the medical devices for which the instructions for use may be provided in electronic form, OJ L, 26.6.2025: https://eur-lex.europa.eu/eli/reg_impl/2025/1234/oj
- Recital 3: extension to devices intended for professional users, including devices under the transitional provisions of Article 120 of Regulation (EU) 2017/745. Recital 4: Annex XVI products for professional use. Recital 7: removal of requirements that are redundant with conformity assessment.
- Article 1: replacement of Article 3(1) and 3(2); deletion of Article 5, point (12); replacement of Article 5, point (13); deletion of Article 6(4); deletion of Article 7(2), point (f); new Article 7(3) on the UDI database; deletion of Article 8.
- Commission Implementing Regulation (EU) 2021/2226 of 14 December 2021 laying down rules for the application of Regulation (EU) 2017/745 as regards electronic instructions for use of medical devices, OJ L 448, 15.12.2021: https://eur-lex.europa.eu/eli/reg_impl/2021/2226/oj
- Article 3(1), (2) and (3): original scope, conditions, and software. Article 4: risk assessment. Article 5: conditions, including point (1) safety, point (3) paper on request, points (9) and (10) retention, point (11) language, point (13) versions. Article 6: label and access information. Article 7: website requirements.
- Commission Regulation (EU) No 207/2012 of 9 March 2012 on electronic instructions for use of medical devices, Article 3(1)(e): “stand-alone software covered by Directive 93/42/EEC”: https://eur-lex.europa.eu/eli/reg/2012/207/oj
- Regulation (EU) 2017/745 on medical devices, Article 1(4): medical devices, accessories and Annex XVI products are together referred to as “devices”: https://eur-lex.europa.eu/eli/reg/2017/745/oj
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/eifu-open-to-every-professional-use-device/ on 13 August 2026. You are welcome to quote or reuse this, with a link back.