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Who owns the eIFU: you or your authorised representative?
Regulation (EU) 2021/2226 assigns every eIFU duty to the manufacturer. What that leaves the authorised representative to verify, hold and produce on request.
A manufacturer established outside the EU can only place devices on the Union market after designating a sole authorised representative (Article 11(1)Article 11(1)Where the manufacturer of a device is not established in a Member State, the device may only be placed on the Union market if the manufacturer designates a sole authorised representative.MDR · consolidated 2026-07-19. Consolidated text is a documentation tool with no legal effect. of the MDR). That representative becomes the manufacturer’s contact point in the Union, holds a defined set of documents, and answers to competent authorities. When such a manufacturer provides its instructions for use electronically, a practical question follows: which of the eIFU obligations move to the representative?
The answer is short. All of the eIFU obligations stay with the manufacturer. The authorised representative verifies that they have been met, keeps the evidence available, and produces it when a competent authority asks. Importers and distributors check what arrives with the device. This post sets out where each of those lines runs, and what happens to the registered eIFU address when the representative changes.
One regulation, one addressee
The conditions for providing instructions for use in electronic form sit in Implementing Regulation (EU) 2021/2226, as amended by Implementing Regulation (EU) 2025/1234. Every obligation in it is assigned to one actor. The permission to go electronic, the risk assessment, the conditions on instructions and label, and the website requirements all address manufacturers (Articles 3 to 7). The terms authorised representative, importer and distributor appear nowhere in the regulation or in its amendment.
Every eIFU obligation in Regulation (EU) 2021/2226 is addressed to the manufacturer.
The MDR points the same way. Ensuring that each device is accompanied by the required information, in the languages the Member States concerned determine, is a manufacturer obligation (Article 10(11)Article 10(11)Manufacturers shall ensure that the device is accompanied by the information set out in Section 23 of Annex I in an official Union language(s) determined by the Member State in which the device is made available to the user or patient. The particulars on the label shall be indelible, easily legible and clearly comprehensible to the intended user or patient.MDR · consolidated 2026-07-19. Consolidated text is a documentation tool with no legal effect.). The mandate between a manufacturer and its authorised representative cannot delegate it, because it sits on the list of obligations the mandate may never transfer (Article 11(4)Article 11(4)The mandate referred to in paragraph 3 of this Article shall not delegate the manufacturer's obligations laid down in Article 10(1), (2), (3), (4), (6), (7), (9), (10), (11) and (12).MDR · consolidated 2026-07-19. Consolidated text is a documentation tool with no legal effect.). The electronic form is simply one permitted way of meeting that obligation (Annex I, Section 23.1(f)Annex I, Section 23.1(f)(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.MDR · consolidated 2026-07-19. Consolidated text is a documentation tool with no legal effect. of the MDR).
Delegating the obligation and outsourcing the work are different things. MDCG 2022-16, the guidance on authorised representatives, notes that the representative is free to assist the manufacturer in performing tasks that the mandate cannot transfer. An authorised representative, or any service provider, can operate the eIFU platform. The responsibility for the conditions stays with you as the manufacturer.
What the authorised representative verifies and holds
The mandate must cover a minimum set of tasks, and the manufacturer must enable the representative to perform them (Article 11(3)Article 11(3)The authorised representative shall perform the tasks specified in the mandate agreed between it and the manufacturer. The authorised representative shall provide a copy of the mandate to the competent authority, upon request.The mandate shall require, and the manufacturer shall enable, the authorised representative to perform at least the following tasks in relation to the devices that it covers:(a) verify that the EU declaration of conformity and technical documentation have been drawn up and, where applicable, that an appropriate conformity assessment procedure has been carried out by the manufacturer;(b) keep available a copy of the technical documentation, the EU declaration of conformity and, if applicable, a copy of the relevant certificate, including any amendments and supplements, issued in accordance with Article 56, at the disposal of competent authorities for the period referred to in Article 10(8);(c) comply with the registration obligations laid down in Article 31 and verify that the manufacturer has complied with the registration obligations laid down in Articles 27 and 29;(d) in response to a request from a competent authority, provide that competent authority with all the information and documentation necessary to demonstrate the conformity of a device, in an official Union language determined by the Member State concerned;(e) forward to the manufacturer any request by a competent authority of the Member State in which the authorised representative has its registered place of business for samples, or access to a device and verify that the competent authority receives the samples or is given access to the device;(f) cooperate with the competent authorities on any preventive or corrective action taken to eliminate or, if that is not possible, mitigate the risks posed by devices;(g) immediately inform the manufacturer about complaints and reports from healthcare professionals, patients and users about suspected incidents related to a device for which they have been designated;(h) terminate the mandate if the manufacturer acts contrary to its obligations under this Regulation.MDR · consolidated 2026-07-19. Consolidated text is a documentation tool with no legal effect. of the MDR). Three of them reach the eIFU directly.
- Verification that the technical documentation and the EU declaration of conformity have been drawn up. For a device supplied with electronic instructions, that documentation should include the documented risk assessment and the verification and validation evidence for the proper design and functioning of the electronic instructions (Articles 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. and 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. of Regulation (EU) 2021/2226).
- Keeping a copy of the technical documentation and the declaration available for competent authorities. The period is at least 10 years after the last device covered by the declaration has been placed on the market, and at least 15 years for implantable devices (Article 10(8)Article 10(8)Manufacturers shall keep the technical documentation, the EU declaration of conformity and, if applicable, a copy of any relevant certificate, including any amendments and supplements, issued in accordance with Article 56, available for the competent authorities for a period of at least 10 years after the last device covered by the EU declaration of conformity has been placed on the market. In the case of implantable devices, the period shall be at least 15 years after the last device has been placed on the market.Upon request by a competent authority, the manufacturer shall, as indicated therein, provide that technical documentation in its entirety or a summary thereof.A manufacturer with a registered place of business outside the Union shall, in order to allow its authorised representative to fulfil the tasks mentioned in Article 11(3), ensure that the authorised representative has the necessary documentation permanently available.MDR · consolidated 2026-07-19. Consolidated text is a documentation tool with no legal effect.). The manufacturer has a matching duty to keep the necessary documentation permanently available to its representative.
- Providing a competent authority, on request, with all the information and documentation necessary to demonstrate the conformity of a device, in an official Union language determined by the Member State concerned.
Read together, these tasks describe a file. A representative taking on a device with electronic instructions should be able to open the risk assessment and the verification and validation evidence. It should hold the arrangements for paper on request, and know where the issued versions and their publication dates are kept. It should also know at which internet address the instructions are published. A representative who cannot produce that file on request is exposed on its own obligations, whatever the state of the manufacturer’s compliance.
The authorised representative’s part is a file: verify that it exists, hold it, and produce it on request.
The representative also carries registration duties of its own. It registers as an economic operator and receives a single registration number (Article 31Article 311. Before placing a device, other than a custom-made device, on the market, manufacturers, authorised representatives and importers shall, in order to register, submit to the electronic system referred to in Article 30 the information referred to in Section 1 of Part A of Annex VI, provided that they have not already registered in accordance with this Article. In cases where the conformity assessment procedure requires the involvement of a notified body pursuant to Article 52, the information referred to in Section 1 of Part A of Annex VI shall be provided to that electronic system before applying to the notified body.2. After having verified the data entered pursuant to paragraph 1, the competent authority shall obtain a single registration number (‘SRN’) from the electronic system referred to in Article 30 and issue it to the manufacturer, the authorised representative or the importer.3. The manufacturer shall use the SRN when applying to a notified body for conformity assessment and for accessing Eudamed in order to fulfil its obligations under Article 29.4. Within one week of any change occurring in relation to the information referred to in paragraph 1 of this Article, the economic operator shall update the data in the electronic system referred to in Article 30.5. Not later than one year after submission of the information in accordance with paragraph 1, and every second year thereafter, the economic operator shall confirm the accuracy of the data. In the event of a failure to do so within six months of those deadlines, any Member State may take appropriate corrective measures within its territory until that economic operator complies with that obligation.6. Without prejudice to the economic operator's responsibility for the data, the competent authority shall verify the confirmed data referred to in Section 1 of Part A of Annex VI.7. The data entered pursuant to paragraph 1 of this Article in the electronic system referred to in Article 30 shall be accessible to the public.8. The competent authority may use the data to charge the manufacturer, the authorised representative or the importer a fee pursuant to Article 111.MDR · consolidated 2026-07-19. Consolidated text is a documentation tool with no legal effect.). It also verifies that the manufacturer has met its UDI and device registration obligations (Article 11(3)(c)Article 11(3)(c)comply with the registration obligations laid down in Article 31 and verify that the manufacturer has complied with the registration obligations laid down in Articles 27 and 29;MDR · consolidated 2026-07-19. Consolidated text is a documentation tool with no legal effect.).
Why a diligent representative asks about the eIFU
The MDR attaches liability to the role. Where a manufacturer outside the Union has failed to meet its obligations under Article 10Article 101. When placing their devices on the market or putting them into service, manufacturers shall ensure that they have been designed and manufactured in accordance with the requirements of this Regulation.2. Manufacturers shall establish, document, implement and maintain a system for risk management as described in Section 3 of Annex I.3. Manufacturers shall conduct a clinical evaluation in accordance with the requirements set out in Article 61 and Annex XIV, including a PMCF.4. Manufacturers of devices other than custom-made devices shall draw up and keep up to date technical documentation for those devices. The technical documentation shall be such as to allow the conformity of the device with the requirements of this Regulation to be assessed. The technical documentation shall include the elements set out in Annexes II and III.The Commission is empowered to adopt delegated acts in accordance with Article 115 amending, in the light of technical progress, the Annexes II and III.5. Manufacturers of custom-made devices shall draw up, keep up to date and keep available for competent authorities documentation in accordance with Section 2 of Annex XIII.6. Where compliance with the applicable requirements has been demonstrated following the applicable conformity assessment procedure, manufacturers of devices, other than custom-made or investigational devices, shall draw up an EU declaration of conformity in accordance with Article 19, and affix the CE marking of conformity in accordance with Article 20.7. Manufacturers shall comply with the obligations relating to the UDI system referred to in Article 27 and with the registration obligations referred to in Articles 29 and 31.8. Manufacturers shall keep the technical documentation, the EU declaration of conformity and, if applicable, a copy of any relevant certificate, including any amendments and supplements, issued in accordance with Article 56, available for the competent authorities for a period of at least 10 years after the last device covered by the EU declaration of conformity has been placed on the market. In the case of implantable devices, the period shall be at least 15 years after the last device has been placed on the market.Upon request by a competent authority, the manufacturer shall, as indicated therein, provide that technical documentation in its entirety or a summary thereof.A manufacturer with a registered place of business outside the Union shall, in order to allow its authorised representative to fulfil the tasks mentioned in Article 11(3), ensure that the authorised representative has the necessary documentation permanently available.9. Manufacturers shall ensure that procedures are in place to keep series production in conformity with the requirements of this Regulation. Changes in device design or characteristics and changes in the harmonised standards or CS by reference to which the conformity of a device is declared shall be adequately taken into account in a timely manner. Manufacturers of devices, other than investigational devices, shall establish, document, implement, maintain, keep up to date and continually improve a quality management system that shall ensure compliance with this Regulation in the most effective manner and in a manner that is proportionate to the risk class and the type of device.The quality management system shall cover all parts and elements of a manufacturer's organisation dealing with the quality of processes, procedures and devices. It shall govern the structure, responsibilities, procedures, processes and management resources required to implement the principles and actions necessary to achieve compliance with the provisions of this Regulation.The quality management system shall address at least the following aspects:(a) a strategy for regulatory compliance, including compliance with conformity assessment procedures and procedures for management of modifications to the devices covered by the system;(b) identification of applicable general safety and performance requirements and exploration of options to address those requirements;(c) responsibility of the management;(d) resource management, including selection and control of suppliers and sub-contractors;(e) risk management as set out in in Section 3 of Annex I;(f) clinical evaluation in accordance with Article 61 and Annex XIV, including PMCF;(g) product realisation, including planning, design, development, production and service provision;(h) verification of the UDI assignments made in accordance with Article 27(3) to all relevant devices and ensuring consistency and validity of information provided in accordance with Article 29;(i) setting-up, implementation and maintenance of a post-market surveillance system, in accordance with Article 83;(j) handling communication with competent authorities, notified bodies, other economic operators, customers and/or other stakeholders;(k) processes for reporting of serious incidents and field safety corrective actions in the context of vigilance;(l) management of corrective and preventive actions and verification of their effectiveness;(m) processes for monitoring and measurement of output, data analysis and product improvement.10. Manufacturers of devices shall implement and keep up to date the post-market surveillance system in accordance with Article 83.11. Manufacturers shall ensure that the device is accompanied by the information set out in Section 23 of Annex I in an official Union language(s) determined by the Member State in which the device is made available to the user or patient. The particulars on the label shall be indelible, easily legible and clearly comprehensible to the intended user or patient.12. Manufacturers who consider or have reason to believe that a device which they have placed on the market or put into service is not in conformity with this Regulation shall immediately take the necessary corrective action to bring that device into conformity, to withdraw it or to recall it, as appropriate. They shall inform the distributors of the device in question and, where applicable, the authorised representative and importers accordingly.Where the device presents a serious risk, manufacturers shall immediately inform the competent authorities of the Member States in which they made the device available and, where applicable, the notified body that issued a certificate for the device in accordance with Article 56, in particular, of the non-compliance and of any corrective action taken.13. Manufacturers shall have a system for recording and reporting of incidents and field safety corrective actions as described in Articles 87 and 88.14. Manufacturers shall, upon request by a competent authority, provide it with all the information and documentation necessary to demonstrate the conformity of the device, in an official Union language determined by the Member State concerned. The competent authority of the Member State in which the manufacturer has its registered place of business may require that the manufacturer provide samples of the device free of charge or, where that is impracticable, grant access to the device. Manufacturers shall cooperate with a competent authority, at its request, on any corrective action taken to eliminate or, if that is not possible, mitigate the risks posed by devices which they have placed on the market or put into service.If the manufacturer fails to cooperate or the information and documentation provided is incomplete or incorrect, the competent authority may, in order to ensure the protection of public health and patient safety, take all appropriate measures to prohibit or restrict the device's being made available on its national market, to withdraw the device from that market or to recall it until the manufacturer cooperates or provides complete and correct information.If a competent authority considers or has reason to believe that a device has caused damage, it shall, upon request, facilitate the provision of the information and documentation referred to in the first subparagraph to the potentially injured patient or user and, as appropriate, the patient's or user's successor in title, the patient's or user's health insurance company or other third parties affected by the damage caused to the patient or user, without prejudice to data protection rules and, unless there is an overriding public interest in disclosure, without prejudice to the protection of intellectual property rights.The competent authority need not comply with the obligation laid down in the third subparagraph where disclosure of the information and documentation referred to in the first subparagraph is ordinarily dealt with in the context of legal proceedings.15. Where manufacturers have their devices designed or manufactured by another legal or natural person the information on the identity of that person shall be part of the information to be submitted in accordance with Article 29(4).16. Natural or legal persons may claim compensation for damage caused by a defective device in accordance with applicable Union and national law.Manufacturers shall, in a manner that is proportionate to the risk class, type of device and the size of the enterprise, have measures in place to provide sufficient financial coverage in respect of their potential liability under Directive 85/374/EEC, without prejudice to more protective measures under national law.MDR · consolidated 2026-07-19. Consolidated text is a documentation tool with no legal effect., the representative is legally liable for defective devices (Article 11(5)Article 11(5)Without prejudice to paragraph 4 of this Article, where the manufacturer is not established in a Member State and has not complied with the obligations laid down in Article 10, the authorised representative shall be legally liable for defective devices on the same basis as, and jointly and severally with, the manufacturer.MDR · consolidated 2026-07-19. Consolidated text is a documentation tool with no legal effect.). That liability runs on the same basis as the manufacturer’s, jointly and severally with it. MDCG 2022-16 explains that it is conditional: the manufacturer’s liability for the defective device has to be established first, together with its failure to meet Article 10.
The duty to supply the required information with the device is one of the Article 10 obligations. An eIFU arrangement that fails its conditions may amount to a failure of that duty. Questions from a prospective representative about hosting, retention periods and paper on request are a direct consequence of the liability it is accepting.
What importers and distributors check
Before placing a device on the market, importers verify that it is labelled in accordance with the MDR and accompanied by the required instructions for use (Article 13(2)Article 13(2)In order to place a device on the market, importers shall verify that:Where an importer considers or has reason to believe that a device is not in conformity with the requirements of this Regulation, it shall not place the device on the market until it has been brought into conformity and shall inform the manufacturer and the manufacturer's authorised representative. Where the importer considers or has reason to believe that the device presents a serious risk or is a falsified device, it shall also inform the competent authority of the Member State in which the importer is established.(a) the device has been CE marked and that the EU declaration of conformity of the device has been drawn up;(b) a manufacturer is identified and that an authorised representative in accordance with Article 11 has been designated by the manufacturer;(c) the device is labelled in accordance with this Regulation and accompanied by the required instructions for use;(d) where applicable, a UDI has been assigned by the manufacturer in accordance with Article 27.MDR · consolidated 2026-07-19. Consolidated text is a documentation tool with no legal effect.). They also verify that an authorised representative has been designated. Distributors verify that the device is accompanied by the information the manufacturer must supply, and may do so using a representative sampling method (Article 14(2)Article 14(2)Before making a device available on the market, distributors shall verify that all of the following requirements are met:In order to meet the requirements referred to in points (a), (b) and (d) of the first subparagraph the distributor may apply a sampling method that is representative of the devices supplied by that distributor.Where a distributor considers or has reason to believe that a device is not in conformity with the requirements of this Regulation, it shall not make the device available on the market until it has been brought into conformity, and shall inform the manufacturer and, where applicable, the manufacturer's authorised representative, and the importer. Where the distributor considers or has reason to believe that the device presents a serious risk or is a falsified device, it shall also inform the competent authority of the Member State in which it is established.(a) the device has been CE marked and that the EU declaration of conformity of the device has been drawn up;(b) the device is accompanied by the information to be supplied by the manufacturer in accordance with Article 10(11);(c) for imported devices, the importer has complied with the requirements set out in Article 13(3);(d) that, where applicable, a UDI has been assigned by the manufacturer.MDR · consolidated 2026-07-19. Consolidated text is a documentation tool with no legal effect.).
For a device supplied with electronic instructions, those checks land on the label and the access information. The label must state that the instructions are supplied in electronic form (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. of Regulation (EU) 2021/2226). Information on how to access them, including how paper can be requested, travels on the packaging or in a paper document with the device. An importer or distributor checking an eIFU device is checking that this access information is present and coherent.
Translation and repackaging are the activities that sit closest to manufacturer territory. A distributor or importer may translate the information supplied with a device, or repackage it for a national market, without taking on the manufacturer’s obligations (Article 16(2)Article 16(2)For the purposes of point (c) of paragraph 1, the following shall not be considered to be a modification of a device that could affect its compliance with the applicable requirements:(a) provision, including translation, of the information supplied by the manufacturer, in accordance with Section 23 of Annex I, relating to a device already placed on the market and of further information which is necessary in order to market the device in the relevant Member State;(b) changes to the outer packaging of a device already placed on the market, including a change of pack size, if the repackaging is necessary in order to market the device in the relevant Member State and if it is carried out in such conditions that the original condition of the device cannot be affected by it. In the case of devices placed on the market in sterile condition, it shall be presumed that the original condition of the device is adversely affected if the packaging that is necessary for maintaining the sterile condition is opened, damaged or otherwise negatively affected by the repackaging.MDR · consolidated 2026-07-19. Consolidated text is a documentation tool with no legal effect.). The same article makes that conditional, on a quality management system certified by a notified body and on advance notice. The language of the published electronic instructions is a separate matter. Making them available in the language each Member State determines is a condition on the manufacturer (Article 5 of Regulation (EU) 2021/2226).
Changing representative without breaking the eIFU
A change of authorised representative must be governed by an agreement between the manufacturer, the incoming representative and, where practicable, the outgoing one (Article 12Article 12The detailed arrangements for a change of authorised representative shall be clearly defined in an agreement between the manufacturer, where practicable the outgoing authorised representative, and the incoming authorised representative. That agreement shall address at least the following aspects:(a) the date of termination of the mandate of the outgoing authorised representative and date of beginning of the mandate of the incoming authorised representative;(b) the date until which the outgoing authorised representative may be indicated in the information supplied by the manufacturer, including any promotional material;(c) the transfer of documents, including confidentiality aspects and property rights;(d) the obligation of the outgoing authorised representative after the end of the mandate to forward to the manufacturer or incoming authorised representative any complaints or reports from healthcare professionals, patients or users about suspected incidents related to a device for which it had been designated as authorised representative.MDR · consolidated 2026-07-19. Consolidated text is a documentation tool with no legal effect. of the MDR). The agreement addresses the dates and the transfer of documents. It fixes how long the outgoing representative may still appear in the information supplied by the manufacturer, and covers complaints that arrive after the mandate ends. For an eIFU device, the transferred documents should include the file described above.
The representative’s name and address appear on the label when the manufacturer is established outside the Union. The instructions for use themselves are under no such requirement. The MDR lists the representative among the label particulars and leaves it out of the list for the instructions (Annex I, Sections 23.2(d)Annex I, Section 23.2(d)(d) if the manufacturer has its registered place of business outside the Union, the name of the authorised representative and address of the registered place of business of the authorised representative;MDR · consolidated 2026-07-19. Consolidated text is a documentation tool with no legal effect. and 23.4(a)Annex I, Section 23.4(a)(a) the particulars referred to in points (a), (c), (e), (f), (k), (l), (n) and (r) of Section 23.2;MDR · consolidated 2026-07-19. Consolidated text is a documentation tool with no legal effect.). A change of representative therefore forces a label change, and it only touches the content of the instructions where the manufacturer chose to name the representative there.
In the UDI database, the representative’s name and address are among the data elements filed against each UDI-DI (Annex VI, Part B, point 7Annex VI, Part B, point 77. if applicable, name and address of the authorised representative (as indicated on the label),MDR · consolidated 2026-07-19. Consolidated text is a documentation tool with no legal effect. of the MDR). A new UDI-DI is only required for changes that could lead to misidentification of the device, such as a new name, model or package quantity. A change of representative leaves the identity of the device untouched, so it is handled as an update to the existing record, made within 30 days.
The eIFU address deserves more care than either of those fields. The internet address at which the instructions are published must remain stable and directly accessible throughout the retention periods (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 periods run to 10 years after the last device is placed on the market, and at least 2 years past the expiry date of the last produced device (Article 5). For implantable devices and devices without an expiry date, they run to 15 years. The manufacturer must also provide that address to the UDI database, at the latest from the date device registration in EUDAMED applies (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.).
An address on the representative’s own domain ties a decade of regulatory commitment to a mandate either party can end.
An address published on a domain that belongs to the representative ties a regulatory commitment of a decade or more to a commercial mandate that either party can end. An address independent of that relationship survives a change of representative with nothing to re-register. That is the arrangement to insist on, whether the instructions sit on your own domain or on a dedicated eIFU platform such as the one Ydntfy operates.
The same architecture for IVDs
The IVDR defines the authorised representative, the importer and the distributor in the same way and assigns them the same roles, in its own Articles 11 to 14. The eligibility rules for electronic instructions differ, because Regulation (EU) 2021/2226 was made under the MDR and applies only to devices within its scope. For in vitro diagnostics, the permission for non-paper instructions sits in the IVDR itself (Annex I, Section 20.1Annex I, Section 20.1General 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. If individual full labelling of each unit is not practicable, the information shall be set out 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 or bar codes.(d) Instructions for use shall be provided together with devices. However, in duly justified and exceptional cases instructions for use shall not be required or may be abbreviated if the device can be used safely and as intended by the manufacturer without any such instructions for use.(e) Where multiple devices, with the exception of devices intended for self-testing or near-patient testing, 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) 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.(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, taking into account the intended users. 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.(i) In the case of devices containing a substance or a mixture which may be considered as being dangerous, taking account of the nature and quantity of its constituents and the form under which they are present, relevant hazard pictograms and labelling requirements of Regulation (EC) No 1272/2008 shall apply. Where there is insufficient space to put all the information on the device itself or on its label, the relevant hazard pictograms shall be put on the label and the other information required by Regulation (EC) No 1272/2008 shall be given in the instructions for use.(j) The provisions of Regulation (EC) No 1907/2006 on the safety data sheet shall apply, unless all relevant information, as appropriate, is already made available in the instructions for use.IVDR · consolidated 2025-01-10. Consolidated text is a documentation tool with no legal effect.). A separate post will take the IVD rulebook on its own.
What to settle in the mandate
The regulation leaves the division of labour to the mandate and the change-of-representative agreement, so that is where to fix it. Four points are worth writing down explicitly for a device with electronic instructions:
- Operation. Which party runs the website, and to what service level.
- Evidence flow. How the representative receives each revision of the risk assessment and each newly issued version of the instructions.
- Paper requests. Who answers a paper request that reaches the representative, and within what time.
- Exit. What happens to the published address if the mandate ends.
Each point has a statutory anchor cited above, and the regulation leaves the answer to the contract.
Sources
Primary sources. Every claim in this post is traceable to one of these, and the sub-provisions behind each paragraph-level citation are itemised here.
Show 6 sources · 3 references
- Regulation (EU) 2017/745 on medical devices (MDR), OJ L 117, 5.5.2017: https://eur-lex.europa.eu/eli/reg/2017/745/oj
- Article 2(32) to (34), definitions. Article 10(8) and (11), manufacturer obligations. Article 11(1), (3), (4) and (5), authorised representative. Article 12, change of authorised representative, points (a) to (d). Article 13(2), importers. Article 14(2), distributors, including the sampling method. Article 16(1) to (4), relabelling, translation and repackaging. Articles 27, 29 and 31, UDI and registration. Annex I, Sections 23.1(f), 23.2(d) and 23.4(a): the representative is a label particular under 23.2(d), and 23.4(a) omits it from the instructions. Annex VI, Part B, points 7 and 22, and Part C, Sections 3.9 and 5.8.
- Commission Implementing Regulation (EU) 2021/2226 on electronic instructions for use, OJ L 448, 15.12.2021: https://eur-lex.europa.eu/eli/reg_impl/2021/2226/oj
- Articles 3 and 4. Article 5, points (3), (5), (9), (10), (11) and (13). Article 6, paragraphs (1) to (3). Article 7(2)(e).
- Commission Implementing Regulation (EU) 2025/1234 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
- Article 1, point (6)(b), inserting Article 7(3) on the UDI database.
- MDCG 2022-16, Guidance on authorised representatives, October 2022: https://health.ec.europa.eu/document/download/0a7613cb-6b9a-4396-a4c6-d2479e43e167_en?filename=mdcg_202216_en.pdf
- MDCG 2021-27 Rev.1, Questions and answers on Articles 13 and 14 of the MDR and IVDR: https://health.ec.europa.eu/system/files/2023-12/mdcg_2021-27_en.pdf
- Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR), OJ L 117, 5.5.2017, Articles 11 to 14 and Annex I, Section 20.1(f): https://eur-lex.europa.eu/eli/reg/2017/746/oj
MDCG guidance documents are endorsed by the Medical Device Coordination Group and are not legally binding.
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/authorised-representative-eifu-responsibility/ on 21 August 2026. You are welcome to quote or reuse this, with a link back.