Annex I Chapter III of Regulation (EU) 2017/745 is the legal anchor for every piece of information a manufacturer supplies with a medical device. Chapter III contains a single section, Section 23, split into four subsections: 23.1 sets the general principles that apply to every piece of information supplied with the device, 23.2 lists what must appear on the label, 23.3 covers the information on the implant card and associated information for implantable devices, and 23.4 lists what must appear in the instructions for use. Every claim on a label, every sentence in an IFU, and every item on an implant card traces to a specific subparagraph of Section 23. Chapter III is not a style guide. It is the checklist an auditor opens first.

By Tibor Zechmeister and Felix Lenhard. Last updated 10 April 2026.

TL;DR

  • MDR Annex I Chapter III is titled "Requirements regarding the information supplied with the device" and consists of a single section — Section 23 — with four subsections: 23.1, 23.2, 23.3, and 23.4.
  • Section 23.1 sets the general principles: information must be supplied on the label, on the packaging, or in the instructions for use in a form that is easily understood by the intended user.
  • Section 23.2 lists every particular that must appear on the label of a medical device. Section 23.3 covers the information on the implant card and information to be supplied to patients with an implanted device. Section 23.4 lists every particular that must appear in the instructions for use.
  • Language is set by Article 10(11): each Member State decides the official Union language(s) required for its territory.
  • Symbols used in place of words must come from a recognised standard — in practice EN ISO 15223-1:2021 — or must be described in the documentation supplied with the device.
  • Chapter III is the single source that governs labels, implant cards, and IFUs together. Treating them as separate deliverables is how gaps appear.

Why Chapter III is one chapter, not three

Founders often think of the label, the implant card, and the instructions for use as three separate documents drafted by three different owners on three different timelines. The Regulation does not see it that way. Annex I Chapter III treats them as one regulated whole: "information supplied with the device." The four subsections of Section 23 are not four independent lists — they are four views of a single obligation, applied to different physical surfaces.

This matters because the Section 23.1 general principles apply across all of them. Language, user-understandability, symbols, and the form in which information is supplied are governed once, at the top of the section, and then inherited by the label rules in 23.2, the implant card rules in 23.3, and the IFU rules in 23.4. A decision made at the 23.1 level — for example, using EN ISO 15223-1:2021 symbols — has to be applied consistently across the label, the implant card, and the IFU. Teams that draft each surface in isolation produce inconsistencies that Section 23.1 then catches at audit.

Chapter III is also the place where the regulation crosses from the technical documentation into the user's hands. Everything before Chapter III — the GSPRs of Chapter I, the requirements regarding design and manufacture of Chapter II — lives inside the technical file. Chapter III is what the user sees. The audit discipline for Chapter III is therefore not "does this document exist?" but "does what we supply with the device match the file, the risk profile, and the clinical evaluation — at every surface the user encounters?"

The scope of Chapter III

Annex I is split into three chapters. Chapter I sets out the general requirements. Chapter II sets out the requirements regarding design and manufacture. Chapter III sets out the requirements regarding the information supplied with the device. Chapter III contains a single section — Section 23 — and that section contains four subsections that, taken together, govern every piece of information that travels with the device. (Regulation (EU) 2017/745, Annex I, Chapter III.)

The scope is broader than founders usually assume. Chapter III governs not only the obvious deliverables (label, IFU) but also the implant card for implantable devices, the information about the identity and manufacturer that must accompany every device regardless of size, and the symbols and colours used in place of words. It also governs how that information relates to the language obligations in Article 10(11) and, for electronic instructions for use, to Commission Implementing Regulation (EU) 2021/2226 as amended. Anything the user reads, sees, or is given with the device falls under Chapter III.

Section 23.1 — general principles

Section 23.1 sets the baseline rules that apply to every piece of information supplied with the device. The principles cover form, medium, language, comprehensibility, and symbols. Reduced to plain language, Section 23.1 requires that:

  • Each device is 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.
  • The information may appear on the device itself, on the packaging, or in the instructions for use, and, where applicable on the sales packaging.
  • The information must be provided in a form that is easily understood by the intended user and, where relevant, supplemented as needed, taking into account the training and knowledge of the intended user.
  • The information required on the label is 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.
  • Where a device is intended only for professional use, the instructions for use may be provided in electronic form in line with the conditions of the applicable implementing regulation.
  • Symbols and identification colours used may be drawn from harmonised standards or common specifications. In fields where no harmonised standard or common specification exists, the symbols and colours used must be described in the documentation supplied with the device.

(Regulation (EU) 2017/745, Annex I, Chapter III, Section 23.1.)

These general principles are why the label, the implant card, and the IFU have to be designed together. A symbol chosen for the label that is not from EN ISO 15223-1:2021 has to be described in the IFU. A language selected for the IFU has to match the language on the label for the same Member State. A piece of information that does not fit on the small label has to appear on the packaging or in the IFU without contradicting what is on the label. Section 23.1 is the glue.

Section 23.2 — the label

Section 23.2 is the specific list of particulars that must appear on the label of every medical device. The full list covers the device name, the manufacturer's identification and registered place of business, details needed to identify the device and its contents, the UDI carrier under Article 27 where the UDI obligation applies to the device class, the lot or serial number, the expiry date or date of manufacture where applicable, special storage or handling conditions, warnings or precautions relevant at point of use, the sterile state and sterilisation method where applicable, the single-use indication where applicable, the words "custom-made device" where applicable, and the indication that the product is a medical device. (Regulation (EU) 2017/745, Annex I, Chapter III, Section 23.2.)

The Section 23.2 list is the starting point for label design. Every element on a compliant label either traces directly to a subparagraph of 23.2 or to a linked article (Article 20 for the CE marking, Article 27 for the UDI carrier, Article 10(11) for language). The full walk-through of the Section 23.2 list and how to handle small labels lives in the dedicated label post.

Section 23.3 — the implant card and information for implantable devices

Section 23.3 governs the information to be supplied with implantable devices — specifically the implant card and the information about the implant that must be given to the patient. The implant card itself is defined in MDR Article 18, which requires the manufacturer of an implantable device to provide, together with the device, the information referred to in Section 23.3 of Annex I, including a patient implant card. (Regulation (EU) 2017/745, Article 18 and Annex I, Chapter III, Section 23.3.)

Section 23.3 requires that the information supplied with the implant card enables the identification of the device — including the device name, serial number, lot number, UDI, device model — and identifies the manufacturer, including its name, address, and website. The information must also include any warnings, precautions, or measures to be taken by the patient or a healthcare professional with regard to reciprocal interference with reasonably foreseeable external influences, medical examinations, or environmental conditions. Expected lifetime and any necessary follow-up belong in the information supplied with the card as well.

The implant card itself is designed to be carried by the patient. It is distinct from the IFU and from the label. It is the surface that accompanies the patient out of the clinic. Section 23.3 and Article 18 together define it, and the content must match the information in the technical documentation and the clinical evaluation. Article 18 also requires that the information supplied on and with the card is written in a way that is readily understood by a lay person and is updated where appropriate. A separate post walks through implant card design in detail.

Section 23.4 — the instructions for use

Section 23.4 is the specific list of particulars that must appear in the instructions for use. The list is long and is mandatory unless the manufacturer can justify in the technical documentation why a specific item is not relevant. It covers the device identification, the manufacturer details, the intended purpose with users and patient groups specified, indications and contraindications, residual risks and undesirable side-effects, preparatory treatment and handling instructions, installation and calibration information, the qualification level required of users, maintenance information, safe disposal, the date of issue or latest revision, a notice that serious incidents should be reported to the manufacturer and competent authority, and — for devices with electronic programmable systems — minimum IT security requirements. (Regulation (EU) 2017/745, Annex I, Chapter III, Section 23.4.)

The full IFU walk-through, including the usability validation that EN 62366-1:2015+A1:2020 requires, lives in the dedicated IFU post. The key point for Chapter III readers is that Section 23.4 is a list with an order. The auditor reads Section 23.4 top to bottom and checks each item against the IFU. An IFU whose table of contents mirrors Section 23.4 passes that check immediately. An IFU that invented its own structure forces the auditor to hunt, and hunting auditors find more findings.

The multi-language requirement

Article 10(11) of Regulation (EU) 2017/745 requires the manufacturer to ensure that the device is accompanied by the information required under Section 23 of Annex I in an official Union language or languages determined by the Member State in which the device is made available to the user or patient. (Regulation (EU) 2017/745, Article 10(11).)

This obligation applies to every subsection of Section 23 uniformly. The label must be in the required language(s). The implant card information must be in the required language(s). The IFU must be in the required language(s). There is no provision for supplying one surface in one language and another surface in another. Each Member State publishes its own requirement, and the requirements differ by user group — some Member States accept English for devices supplied only to professional users, most do not accept English for devices supplied to lay users, and several require the national language regardless of user group.

The practical consequence is that translation is a Chapter III decision, not a post-hoc tactical step. Every added language multiplies the cost of every future change across all three surfaces — label, implant card, IFU — in lockstep. A disciplined subtraction pass on each surface before translation is the single biggest cost saver in the Chapter III workstream.

Common mistakes startups make with Chapter III

The same handful of failure modes accounts for most Chapter III findings at audit.

  • Treating the label, the implant card, and the IFU as separate projects. Inconsistencies between them are caught by Section 23.1, because 23.1 applies to all of them.
  • Using symbols that are not from EN ISO 15223-1:2021 and not described in the IFU. A Section 23.1(h) finding every time.
  • Writing an IFU in a structure the team invented instead of one that mirrors the Section 23.4 list. The auditor loses the thread; findings multiply.
  • Omitting items from the Section 23.2 label list because "the label was too small" without documenting where those items live on the sales packaging or in the IFU. Chapter III allows distribution; it does not allow omission.
  • Missing the implant card entirely for devices covered by Article 18, or shipping an implant card that is not written in language a lay person can understand.
  • Translating some surfaces but not others for a given Member State. Article 10(11) applies across Section 23 as a whole.
  • Copying symbols, warnings, or disclaimers from competitor packaging without checking what the current edition of the standard actually specifies.

Each of these has a direct mapping to a subparagraph of Section 23. None of them is creative; all of them are preventable by reading Chapter III in full before drafting anything.

The Subtract to Ship angle on Chapter III

Chapter III is where bloat accumulates fastest. Every team member wants to add something to the label. Marketing wants a tagline. Legal wants a disclaimer. Engineering wants a specification. The implant card gets every "just in case" warning. The IFU grows by accretion until it is too long to translate affordably and too long for the user to follow.

Subtract to Ship for Chapter III is the opposite move. Start from the four subsections of Section 23 as the complete universe of what belongs in information supplied with the device. Map every element on every surface back to a specific subparagraph of 23.1, 23.2, 23.3, or 23.4 — or to Article 10(11), Article 18, Article 20, or Article 27. Anything that does not trace to one of those sources does not belong on any of the three surfaces. Anything that does belong must appear consistently across all the surfaces where it is required, in the language each Member State demands, using symbols from EN ISO 15223-1:2021 where applicable.

The discipline compounds. A shorter, tighter Chapter III deliverable set is cheaper to translate, faster to revise, and easier to keep consistent across the label, the implant card, and the IFU. See the Subtract to Ship framework for MDR for the broader methodology.

Reality Check — Where do you stand?

  1. Can you draw a single diagram showing how your label (Section 23.2), your implant card if applicable (Section 23.3), and your IFU (Section 23.4) connect to Section 23.1's general principles?
  2. Is every element on every surface traceable to a specific subparagraph of Section 23, or to Articles 10(11), 18, 20, or 27?
  3. Do your label, implant card (if applicable), and IFU use the same language(s) for a given Member State, consistent with Article 10(11)?
  4. Are all symbols on your label and in your IFU from the current edition of EN ISO 15223-1:2021, with any non-standard symbols described in the IFU?
  5. If your device is implantable, does your implant card content match Section 23.3 and Article 18 requirements, and is it written in language a lay person can understand?
  6. Does your IFU table of contents mirror the order of Section 23.4 so that an auditor can check items top to bottom without hunting?
  7. When was the last time you cut content from any Chapter III surface rather than added it?

Frequently Asked Questions

What exactly is Annex I Chapter III of MDR? Annex I Chapter III of Regulation (EU) 2017/745 is titled "Requirements regarding the information supplied with the device." It contains a single section — Section 23 — which is split into four subsections: 23.1 (general principles), 23.2 (information on the label), 23.3 (information on the implant card and information for implantable devices), and 23.4 (information in the instructions for use).

Does Chapter III apply to every medical device? Yes. Section 23.1 and Section 23.2 apply to every device under MDR. Section 23.4 applies to every device that requires an IFU — which is nearly all of them under Section 23.1's user-understandability principle. Section 23.3 applies specifically to implantable devices, alongside Article 18 on the implant card.

Where do multi-language obligations come from? Article 10(11) of Regulation (EU) 2017/745 requires the manufacturer to supply the information in an official Union language or languages determined by each Member State in which the device is made available. The obligation applies uniformly to the label, the implant card, and the IFU for that Member State.

Is Chapter III the same as the technical documentation? No. Chapter III is part of the general safety and performance requirements of Annex I. The technical documentation itself is governed by Annex II. The Chapter III deliverables — label, implant card, IFU — are supplied with the device, and copies or masters of them are held inside the technical documentation under Annex II Section 2. Chapter III is the obligation; Annex II is where the file evidencing that obligation sits.

What standard covers symbols used on the label and in the IFU? The standard referenced in practice is EN ISO 15223-1:2021, "Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements." Symbols not from a recognised standard must be described in the documentation supplied with the device, per Section 23.1(h).

Does every implantable device need an implant card? Article 18 of Regulation (EU) 2017/745 requires manufacturers of implantable devices to provide an implant card together with the device, with the information set out in Section 23.3 of Annex I. A small number of implantable devices are excluded from this requirement by Article 18(3) — the list is defined in the article itself. For every other implantable device, the implant card is mandatory.

Sources

  1. Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, Article 10(11) (language of information supplied with the device), Article 18 (implant card and information to be supplied to the patient with an implanted device), Annex I, Chapter III, Section 23.1 (general principles for information supplied with the device), Section 23.2 (information on the label), Section 23.3 (information on the implant card and information to be supplied to patients with an implanted device), Section 23.4 (information in the instructions for use). Official Journal L 117, 5.5.2017.
  2. EN ISO 15223-1:2021 — Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements.
  3. EN 62366-1:2015+A1:2020 — Medical devices — Part 1: Application of usability engineering to medical devices (IEC 62366-1:2015 + IEC 62366-1:2015/A1:2020).

This post is part of the Technical Documentation & Labeling cluster in the Subtract to Ship: MDR blog. Authored by Felix Lenhard and Tibor Zechmeister. Chapter III is one chapter because the label, the implant card, and the instructions for use are one obligation — read them together, draft them together, and audit them together, or the gaps between them will find you at the worst possible moment.