Medical Device Labelling Requirements Under MDR Annex I Section 23
Updated: Aug 30
Medical device labelling requirements sit in one place in the MDR — Annex I, Chapter III, Section 23 — and almost every finding written against them is a counting error. Section 23.1 runs from point (a) to point (h). Section 23.2 runs to point (s). Section 23.3 runs to point (j). Section 23.4 runs to point (ab). There is no Section 23.5. A checklist built on shorter lists is incomplete before it is applied.
Where the medical device labelling requirements sit: Annex I, Chapter III, Section 23
Section 23.1 sets the general requirements for the information supplied by the manufacturer. Point (a) requires the medium, format, content, legibility and location to be appropriate to the device, its intended purpose and the technical knowledge of the intended users. Point (b) requires the label on the device itself, or where that is not practicable on the unit packaging or on the packaging of multiple devices. Point (c) allows human-readable information to be supplemented by machine-readable forms such as radio-frequency identification or bar codes. Point (d) requires instructions for use to accompany devices, with an exception for class I and class IIa devices where they can be used safely without any.
Points (e) to (h) carry the operational detail. Point (e) allows a single copy of the instructions for use where multiple devices are supplied to a single user or location, subject to the purchaser’s agreement, with further copies free on request. Point (f) permits instructions for use in a form other than paper in accordance with the applicable Commission Regulation. Point (g) requires residual risks to be stated as limitations, contra-indications, precautions or warnings. Point (h) is the symbols provision, and it is the one most often breached: symbols and identification colours must be internationally recognised and conform to harmonised standards or common specifications, and where none exist they must be described in the documentation supplied with the device.
The structural point worth carrying into your file review is that the medical device labelling requirements do not distinguish by class. Class I devices are subject to the same Section 23 content as class III devices. What varies is the extent of notified body scrutiny, not the labelling obligation.
What goes on the label: Section 23.2, point by point
The medical device labelling requirements for the label itself sit in nineteen points. Points (a) to (c) cover identity: the name or trade name of the device; the details strictly necessary for the user to identify the device, the contents of the packaging and, where not obvious, the intended purpose; and the name, registered trade name or registered trade mark of the manufacturer with the address of its registered place of business. Point (d) is the one that concerns every reader of this site: where the manufacturer has its registered place of business outside the Union, the label must carry the name of the authorised representative and the address of the representative’s registered place of business.
Points (e) to (h) cover composition and identifiers: an indication that the device incorporates a medicinal substance, a human blood or plasma derivative, or tissues or cells of human or animal origin; the information required by Section 10.4.5; the lot or serial number preceded by the words LOT NUMBER or SERIAL NUMBER or an equivalent symbol; and the UDI carrier referred to in Article 27(4) and Part C of Annex VI. That last cross-reference is worth checking in your own copy. The Regulation as originally published in OJ L 117 of 5 May 2017 pointed to Part C of Annex VII; it was corrected to Annex VI by the corrigendum published in OJ L 334 of 27 December 2019.
Points (i) to (o) cover time, condition and handling: the time limit for using or implanting the device safely, expressed at least as year and month; the date of manufacture where there is no such time limit; special storage or handling conditions; the sterile state and the sterilisation method; warnings or precautions requiring immediate attention; single use; and reprocessed single-use device. The remaining points cover custom-made devices, the indication that the product is a medical device or is exclusively for clinical investigation, the qualitative and quantitative composition of substance-based devices that are absorbed or locally dispersed, and the serial number of implantable devices. A bare “Batch” or “REF” string is not compliant with point (g), which requires the words or the equivalent symbol.
Sterile packaging and the instructions for use
Section 23.3 governs the packaging which maintains the sterile condition, and it runs to ten points. It requires an indication permitting recognition as sterile packaging, a declaration of the sterile condition, the sterilisation method, the manufacturer’s name and address, a description of the device, the words “exclusively for clinical investigations” where applicable, an indication of a custom-made device where applicable, the month and year of manufacture, the time limit for safe use or implantation expressed as year and month, and an instruction to check the instructions for use for what to do if the sterile packaging is damaged or unintentionally opened. The last four are under-applied more often than the first six.
Section 23.4 governs the instructions for use and runs from point (a) to point (ab). It begins by requiring the Section 23.2 particulars, then adds the intended purpose with indications, contra-indications, patient target groups and intended users; the expected clinical benefits; where the summary of safety and clinical performance is available; the performance characteristics; residual risks, contra-indications and undesirable side-effects; preparatory treatment, sterilisation and disinfection; installation verification, maintenance and calibration; what to do if sterile packaging is damaged; reprocessing information for reusable devices; risks if a single-use device is reused; interference and environmental warnings; safe disposal; the issue or revision date of the instructions; and a notice to the user and patient that any serious incident should be reported to the manufacturer and the competent authority.
Two further points sit at the end of that list and often sit nowhere in the file. One requires the information to be supplied to the patient with an implanted device in accordance with Article 18. The other requires the minimum requirements concerning hardware, IT networks characteristics and IT security measures for devices that incorporate programmable electronic systems or software. Article 18 itself excludes sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors from the implant card, and MDCG 2019-8 v2 of March 2020 sets the practical rules — including a minimum text height of 2 mm.
Language: the obligation that cannot be delegated
Article 10(11) is short and decisive: manufacturers shall ensure that the device is accompanied by the information set out in 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. The choice is the Member State’s, not the manufacturer’s, and it is made market by market. A single English label is not a general failure — it is a per-market failure, repeated in every Member State that requires its national language.
The Commission publishes a language table for exactly this purpose, “MDR — Language requirements for manufacturers”, DG SANTE, Rev. 3, August 2025, which sets out label, instructions for use and implant card requirements per Member State. The pattern is that the label almost always requires the national language, that the instructions for use frequently allow English where the device is for professional users, and that the implant card usually requires the national language. Ireland and Malta accept English throughout.
Now the nuance that most mandates get wrong. Article 11(4) provides that the mandate given to an authorised representative shall not delegate the manufacturer’s obligations laid down in Article 10(1), (2), (3), (4), (6), (7), (9), (10), (11) and (12). Article 10(11) is on that list. Labelling and language compliance cannot be moved to the representative by contract. What the representative does hold is Article 11(3)(b), the copy of the documentation, and Article 11(3)(d), the duty to provide a competent authority on request with the information necessary to demonstrate conformity in an official Union language determined by the Member State concerned. Note also that Article 41 MDR, headed “Language requirements”, is not a labelling provision at all — it governs the documents submitted under Articles 38 and 39 for the designation of conformity assessment bodies.
Symbols, the CE marking and electronic instructions for use
Symbols are governed by Annex I 23.1(h) and by whichever standard is cited in the Official Journal. EN ISO 15223-1:2021 was cited under the MDR by Commission Implementing Decision (EU) 2022/6 of 4 January 2022, published in OJ L 1 of 5 January 2022. Amendment A1:2025 was added by Commission Implementing Decision (EU) 2026/1231 of 11 June 2026, published in OJ L, 2026/1231, of 17 June 2026. EN ISO 20417, which many manufacturers cite for information supplied by the manufacturer, is not on the harmonised list under the MDR — it may be applied, but it confers no presumption of conformity, and a symbol justified only by reference to it falls back on the second limb of 23.1(h), description in the accompanying documentation.
The CE marking sits in Article 20 and Annex V. Article 20(3) requires it to be affixed visibly, legibly and indelibly to the device or its sterile packaging, or to the packaging where that is not possible or warranted, and to appear in any instructions for use and on any sales packaging. Article 20(5) requires the identification number of the notified body to follow the marking where applicable, and to be indicated in any promotional material claiming CE conformity. Annex V requires the vertical dimension of the components to be substantially the same and not less than 5 mm, waivable for small-scale devices. Note that the Regulation says “identification number” — four digits is a characteristic of the numbers actually assigned, not a legal requirement.
Electronic instructions for use are governed by Commission Implementing Regulation (EU) 2021/2226 of 14 December 2021, published in OJ L 448 of 15 December 2021, which repealed Regulation (EU) No 207/2012. Article 3 limits eIFU-only supply to implantable and active implantable devices and their accessories, fixed installed devices and their accessories, and devices with a built-in system visually displaying the instructions — in each case where the device is intended for exclusive use by professional users and use by others is not reasonably foreseeable. Article 4 requires a documented risk assessment. Article 5 requires a paper copy at no additional cost within the period set in that assessment and at the latest within seven calendar days, and sets availability at ten years after the last device was placed on the market for devices with a defined expiry date, fifteen years for devices without one and for implantable devices. Article 6 requires the label to state clearly that the instructions are supplied in electronic form instead of in paper form, and provides that any part of the instructions intended for the patient with an implantable device must not be supplied electronically. Article 7 governs the website, including keeping all previous versions archived with their publication dates.
Where medical device labelling requirements fail in practice
Four failures account for most findings against medical device labelling requirements. The first is the added label. Article 13(3) requires importers to indicate their details on the device, the packaging or an accompanying document, and to ensure that any additional label does not obscure any information on the label provided by the manufacturer. Where the added label goes further than that, Article 16(2) becomes relevant: translation of the Section 23 information and changes to outer packaging are permitted, but Article 16(3) then requires a quality management system covering translation accuracy and preservation of the original condition, and Article 16(4) requires at least 28 days’ prior notice to the manufacturer and the competent authority together with a notified body certificate attesting compliance of that system.
The second is the symbol with nothing behind it. A symbol that is neither in a harmonised standard nor described in the documentation supplied with the device fails 23.1(h) on inspection, and the position has tightened now that A1:2025 is cited and EN ISO 20417 is not. The third is the measuring function. Annex I, Chapter II, Section 15 covers devices with a diagnostic or measuring function, and Section 15.2 requires measurements to be expressed in legal units conforming to Council Directive 80/181/EEC — a requirement that pairs with the class Im conformity assessment route and is frequently absent from the label review.
The fourth is direct marking. Annex VI, Part C, Section 4.10 requires reusable devices to bear a UDI carrier on the device itself, and where the device requires cleaning, disinfection, sterilisation or refurbishing between patient uses, that carrier must be permanent and readable after each reprocessing throughout the intended lifetime of the device. Exemptions exist where direct marking would interfere with safety or performance or is technologically not possible, but they must be justified in the file rather than assumed. None of these four is expensive to fix before printing, and all four are expensive to fix afterwards. We are not a law firm and do not provide legal advice.
Sources
Regulation (EU) 2017/745, Articles 10(11), 11(3), 11(4), 13(3), 16, 18, 20, 27(4) and 41; Annex I Chapter II Section 15 and Chapter III Section 23; Annex V; Annex VI Part C
Corrigendum to Regulation (EU) 2017/745, OJ L 334, 27 December 2019, p. 165 (Annex I, Section 23.2, cross-reference to Part C of Annex VI)
Commission Implementing Regulation (EU) 2021/2226 of 14 December 2021 on electronic instructions for use of medical devices, OJ L 448, 15 December 2021, p. 32
Commission Implementing Decision (EU) 2021/1182 of 16 July 2021, OJ L 256, 19 July 2021; as amended by Implementing Decision (EU) 2022/6 of 4 January 2022, OJ L 1, 5 January 2022; and Implementing Decision (EU) 2026/1231 of 11 June 2026, OJ L, 2026/1231, 17 June 2026
European Commission, DG SANTE — MDR: Language requirements for manufacturers, Rev. 3, August 2025; MDCG 2019-8 v2 — Guidance document on Implant Card relating to the application of Article 18, March 2020
Who wrote this
Medex is a medical device manufacturer established in Ankara and a registered authorised representative in EUDAMED under SRN TR-AR-000057550. We are not a law firm and do not provide legal advice. Send us your device list and your current label artwork, and we will respond in writing.
Medex acts as EU authorised representative for manufacturers outside the Union and files their EUDAMED registrations, including the UDI carrier data that has to match what is printed on the label.
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