EU MDR Labeling Requirements: Labels, Instructions for Use and the Languages They Must Be In
The EU MDR labeling requirements are set out in Annex I, Section 23 of Regulation (EU) 2017/745: what must appear on the label, on sterile packaging and in the instructions for use, and when instructions may be electronic. Article 10(11) then adds the language rule: all of that information must be in the official EU language or languages chosen by each Member State where the device reaches users or patients. DEMA Solutions helps device manufacturers translate this documentation and keep every language version in step with every revision.
Who this guide is for
This article is written for the people who carry labeling and instructions from the design office to the market: technical documentation managers, regulatory affairs specialists and quality managers at manufacturers that sell devices in several EU countries. Many of them work at companies that also build machinery or industrial equipment, where hospital beds, sterilisers, imaging systems or rehabilitation equipment sit next to more traditional product lines.
The questions they ask are practical. What exactly has to be on the label? How much of the instructions can be electronic? Which languages does each market expect, and who checks? And how do you keep fifteen language versions correct when the source changes every few months? The sections below answer each one, with the article references so you can check them against the Regulation (EU) 2017/745 yourself.
What the MDR means by "information supplied by the manufacturer
The MDR does not treat the label and the instructions for use as two separate documents. Section 23.1 of Annex I describes a single body of information that identifies the device and its manufacturer and gives users the safety and performance information they need. That information can sit on the device itself, on its packaging or in the instructions for use, and if the manufacturer has a website, it must also be available and kept up to date there.
Section 23.1 sets the ground rules for all of it. The medium, format, content, legibility and location must suit the device, its intended purpose and the knowledge and training of the intended user, and instructions must be “written in terms readily understood by the intended user”, supported by drawings and diagrams where appropriate. Label information belongs on the device; only when that is not practicable may some or all of it move to the unit packaging or to the packaging of multiple devices. Labels must be human-readable, and may be supplemented by machine-readable formats such as RFID or barcodes.
Two consequences matter for anyone planning translations. First, the readability requirement is tied to the intended user, which means a device used by surgeons and a device used at home by patients need different writing, not just different languages. Second, because the same information is spread across device, packaging, instructions and website, a change in one place usually means a change in several, in every language.
What must appear on the label
Section 23.2 lists the particulars the label must carry. Grouped by purpose, they are easier to plan for.
Identification. The name or trade name of the device, the details a user needs to identify it and the contents of the packaging, and its intended purpose where that is not obvious. The manufacturer’s name or registered trade mark and the address of its registered place of business, plus the authorised representative’s name and address if the manufacturer is based outside the EU. An indication that the product is a medical device, the words “custom-made device” where relevant, and “exclusively for clinical investigation” for investigational devices.
Traceability. The lot number or serial number, preceded by the words LOT NUMBER or SERIAL NUMBER or an equivalent symbol, and the UDI carrier required by Article 27 and Annex VI. For active implantable devices the serial number, and for other implantables the serial number or lot number. An unambiguous use-by date expressed at least as year and month where relevant, or the date of manufacture where there is no use-by date.
Safe use. Special storage or handling conditions, the sterile state and sterilisation method for sterile devices, and the warnings or precautions that need the user’s immediate attention. The label may keep warnings to a minimum, provided the full detail is in the instructions for use. Single-use devices must say so, consistently across the Union, and reprocessed single-use devices must state that fact, the number of reprocessing cycles performed and any limit on further cycles.
Content declarations. Where applicable, an indication that the device contains a medicinal substance, tissues or cells of human or animal origin, or substances labeled under Section 10.4.5, and for substance-based devices, the qualitative composition and quantitative information on the main constituents.
Sterile packaging has its own short list in Section 23.3: an indication that it is sterile packaging, a declaration of the sterile condition, the sterilisation method, manufacturer name and address, a description of the device, month and year of manufacture, the use-by date and an instruction to check the instructions for use if the packaging is damaged or opened before use.
Read with translation in mind, the label is a mix of text that must be translated (intended purpose, warnings, storage conditions, device description), text that must never change (UDI, lot and serial numbers, dates) and text that can be replaced by symbols. Planning which is which, once, saves a great deal of rework on every label.
What the instructions for use must contain
Section 23.4 is longer, and it is where most of the translation volume sits, which is why IFU translation deserves its own planning rather than being treated as an afterthought. The instructions for use must repeat the key label particulars and then cover the device’s intended purpose with indications, contra-indications, patient target groups and intended users; the expected clinical benefits; a link to the summary of safety and clinical performance where Article 32 requires one; and the device’s performance characteristics.
The practical core follows: any residual risks, contra-indications and side-effects; preparatory treatment or handling before use, such as sterilisation, final assembly or calibration; special facilities, training or qualifications the user needs; how to verify correct installation, with preventive maintenance, consumables and calibration where relevant; cleaning, disinfection and re-sterilisation for reusable devices, including when a device should no longer be reused; and safe combinations with other devices or equipment. Devices that emit radiation need information on its nature and on protection. The warnings section must let users, and where relevant patients, understand malfunctions, environmental influences such as magnetic fields or electromagnetic interference, and interactions during other medical procedures.
Three items deserve particular attention from a documentation team:
- Point (y): the date of issue of the instructions for use, or the date and identifier of the latest revision. Every language version therefore carries a revision identity, and a translation that lags behind the source is visibly out of date.
- Point (z): a notice that serious incidents should be reported to the manufacturer and to the competent authority of the Member State where the user or patient is established.
- Point (ab): for devices with software or programmable electronics, the minimum hardware, IT network and IT security requirements needed to run the software as intended. These sections are often written by engineering teams and translated late, which is where inconsistencies with the user interface creep in.
For devices intended for lay users, the instructions must also say when the user should consult a healthcare professional. And there is one exemption: class I and class IIa devices do not need instructions for use if they can be used safely without them, under Section 23.1(d).
MDR language requirements: Article 10(11) and the Member State rule
The language obligation sits with the manufacturer. Article 10(11) requires the device to be accompanied by the information in Annex I, Section 23 “in an official Union language(s) determined by the Member State in which the device is made available to the user or patient”, and the particulars on the label must be indelible, easily legible and clearly comprehensible to the intended user or patient.
The MDR itself lists no languages. Each Member State decides, and several distinguish between devices for professional users and devices for patients or lay users, sometimes accepting English for professional-only equipment. Because these national rules vary and change, the safe approach is to keep a market-by-market language matrix in your regulatory file and to review it whenever you enter a new country.
The obligation follows the device, not the manufacturer. A device made in Italy and sold in Austria, Belgium and Finland needs its information in the languages those countries require, whatever language the technical documentation was written in. Distributors check it too: under Article 14(2)(b) they must verify that the device is accompanied by the information required by Article 10(11) before making it available. In practice, a missing language version is more likely to stop a shipment at the distributor than to be found by an authority.
The same national logic applies beyond the label and instructions:
- EU declaration of conformity (Article 19(1)): translated into the official language or languages required by each Member State where the device is made available.
- Field safety notices (Article 89(8)): in the language or languages of the Member State where the field safety corrective action is taken, with consistent content across Member States unless a difference is justified.
- Documentation for competent authorities (Article 10(14)): on request, in an official Union language determined by the Member State concerned.
- Notified body documentation and certificates (Articles 52(12) and 56(1)): in a language set by the notified body’s Member State, or otherwise one acceptable to the notified body.
Implant cards and patient information
For implantable devices, Article 18 adds a separate set of documents aimed at the patient. The manufacturer must provide information identifying the device (name, serial and lot number, UDI, model, manufacturer name, address and website), warnings about interference with external influences, medical examinations or environmental conditions, information on the expected lifetime and necessary follow-up, and anything else the patient needs for safe use. Part of it also goes on the implant card delivered with the device.
This information must be in the language or languages determined by the Member State concerned, written so that a lay person can readily understand it, and updated where appropriate, with updates made available to patients through the manufacturer’s website. That combination is demanding for translation. Accurate clinical text is not enough; it has to read naturally to a patient, which is a different skill. Our plain language service exists for exactly that gap, and the same principle applies to any instructions written for home use.
Electronic instructions for use (eIFU)
Section 23.1(f) allows instructions in non-paper form only to the extent set by the implementing rules, now Commission Implementing Regulation (EU) 2021/2226. It is narrower than many teams expect.
Under Article 3 of that regulation, electronic instructions may replace paper only for implantable and active implantable devices and their accessories, fixed installed devices and their accessories, and devices with a built-in system that displays the instructions, and only when they are intended exclusively for professional users and use by other persons is not reasonably foreseeable. Software that is itself a medical device may provide its instructions through the software.
Choosing eIFU also brings obligations: a documented risk assessment, a system to supply paper instructions at no additional cost within the time set in that assessment and at the latest within seven calendar days of a request, availability in every Member State where the device is made available unless the risk assessment justifies otherwise, and a website that keeps all previous versions and their publication dates. The part of the instructions intended for patients of implantable devices may not be provided only in electronic form.
For translation, eIFU does not reduce the work. Every language version still has to exist, match the edition shipped with the device and be archived when it is superseded. It does make version control visible: if the German PDF on your website is two revisions behind the Italian one, anyone can see it.
Symbols, UDI and what you do not translate
Section 23.1(h) encourages internationally recognised symbols, and symbols and identification colours must conform to harmonised standards or common specifications; in the absence of either, they must be described in the documentation supplied with the device. Using the harmonised symbol standard for medical device labels lets many labels carry far less text, which saves space on small packaging and reduces translation.
Symbols do not remove language, though. Warnings, contra-indications, residual risks, set-up steps and patient information still need full text in every required language, and the explanation of the symbols used normally appears in the instructions for use, which must be translated too. The UDI carrier, lot and serial numbers and dates are the opposite case: they must never be altered by translation, and date formats must remain unambiguous in every language. A good translation process marks these elements as locked from the start.
Devices that are also machinery
Many of the manufacturers we work with build equipment that sits on both sides of the line: a patient lift, a steriliser, a surgical table or a rehabilitation system can be a medical device and machinery at the same time. Article 1(12) of the MDR states that devices which are also machinery must, where a relevant hazard exists, also meet the essential health and safety requirements of the machinery legislation to the extent those are more specific than the MDR’s own requirements.
The MDR text still refers to the Machinery Directive 2006/42/EC, which is replaced by the Machinery Regulation (EU) 2023/1230 from 20 January 2027. If your product range includes this kind of equipment, plan the two sets of documentation together. Our article on what the Machinery Regulation requires for translated instructions covers the machinery side, and our guide to user manual translation explains the general rules for instructions across EU product legislation.
The translation workload behind MDR labeling
Taken together, these requirements turn labeling into a continuous process rather than a one-off translation job. Multiply the documents (label, sterile packaging, instructions for use, implant card, patient information, declaration of conformity, software interface, field safety notice templates) by the languages of every market you sell in, then by the number of revisions each year. Twenty device families, five core documents each and fifteen languages already add up to 1,500 controlled language files, before a single revision.
Each revision has a source: a design change, a new indication, feedback from post-market surveillance, a vigilance case, a notified body finding or a new market. Because the instructions carry a revision identifier, every change needs every language updated, checked and released together. When that does not happen, the failures are rarely exotic regulatory issues. They are ordinary translation problems with regulatory consequences.
Terminology drifts between documents. The label, the instructions, the software interface and the field safety notice use different words for the same component or the same action, because they were translated at different times by different people. A user who reads “release valve” in the manual and sees a different term on the screen hesitates at exactly the wrong moment.
Numbers and units change. Dosages, settings, tolerances and storage temperatures are reformatted or converted along the way, or decimal separators are changed inconsistently. These are the errors that matter most and that a reviewer reading for style is least likely to catch.
Patient text is written for professionals. Implant information and home-use instructions are accurate but not readily understood by the person who has to follow them, which is exactly what Section 23.1(a) and Article 18 rule out.
Language versions fall out of step. The source instructions are revised after a design change, and one or two languages are not updated with them. With eIFU and revision identifiers, the gap is visible to anyone who looks.
Old translations are reused without checking. Text recycled from earlier documents no longer matches the current device or the current terminology, and nobody notices because it looks familiar.
How to build a labeling translation process that holds up
The manufacturers who handle this well treat translation as part of their documentation and change control process, not as a purchase made after the source is final. In practice, that comes down to six habits.
Keep a market and language matrix. For every Member State you sell into, record the languages required for labels, instructions and patient information, and whether the rule differs for professional and lay users. Review it with your distributors and authorised representative when you enter a market, and attach it to each translation request so nothing depends on memory.
Approve terminology before you translate. A multilingual glossary approved once by your regulatory and clinical experts keeps the label, instructions, software and notices consistent across languages and suppliers. Our article on keeping technical terminology consistent across translators and suppliers explains how to build one and keep it alive.
Own your translation memory. Approved sentences should be reused in every update, so a changed warning is translated once and the rest stays exactly as approved. That only works if the memory belongs to you, in a portable format, rather than to whichever supplier did the last job, which is the subject of who owns your translation memory.
Revise every translation, and check reused text again. A second qualified linguist with a medical background should compare each translation with the source, and in medical projects, text reused from the memory deserves a second look too. The questions worth asking a supplier about this are in how to check a supplier’s quality before you hire them.
Link translation to change control. Every design change, labeling change or field safety corrective action should trigger the affected language versions automatically, with the same revision identifier and date as the source. Releasing all languages together is the simplest way to make sure point (y) of Section 23.4 is true in every market.
Solve layout in the source files. Labels and leaflets have fixed space and regulatory layouts, and translated text often runs noticeably longer than the source. Text expansion has to be handled in the original InDesign, label template or XML files, not by shrinking type until it is no longer legible. That is the work of multilingual desktop publishing.
Is machine translation acceptable for MDR documentation?
Machine translation can help with large, repetitive document sets such as service manuals or internal technical documentation, especially when it runs on your own approved glossary and memory. For instructions for use, warnings, patient information and anything a notified body reviews, the safe route is human translation or a full post-edit by a qualified medical linguist, followed by a second check. Where that line falls is covered in our guide to post-editing for technical documentation.
How DEMA Solutions supports device manufacturers
Our medical device translation services cover the documents described above, from the instructions in the box to the technical documentation your notified body reviews. The process is ISO 17100 certified, with a second qualified linguist revising every translation; details are on our quality page.
We work with linguists who specialise in medical content and understand what an instruction is asking the user to do. Before delivery, systematic checks cover terminology, numbers and formatting, and in medical projects, translations reused from the memory are checked a second time. Your glossary and translation memory are built around your device terminology and stay yours, in portable formats. Our in-house DTP team handles labels, leaflets, instructions and electronic outputs in their original formats, and patient-facing texts can be adapted into plain language.
Where TUBE fits
For manufacturers whose instructions and labels change with every product or regulatory update, TUBE keeps the language of each edition under your control. Your glossary and translation memory control machine translation, every approved translation goes into a memory you own, and leverage reporting shows how much of each update comes from text you have already approved.
Frequently asked questions
They are set out in Annex I, Section 23 of Regulation (EU) 2017/745. Section 23.2 lists what the label must carry, including device and manufacturer identification, lot or serial number, the UDI carrier, use-by date, storage conditions and warnings. Section 23.3 covers sterile packaging and Section 23.4 lists the content of the instructions for use. Article 10(11) requires all of it in the languages set by each Member State.
No. Article 10(11) requires an official Union language or languages determined by each Member State where the device is made available to the user or patient. You need to check the national rules of each market and record them in a language matrix.
Only where the Member State concerned accepts it. Some countries accept English for devices used exclusively by professionals; others require the national language or languages for all devices. Patient and lay-user information almost always has to be in the national language.
Under Implementing Regulation (EU) 2021/2226, only for implantable and active implantable devices, fixed installed devices and devices with a built-in display of the instructions, when they are intended exclusively for professional users, and for software through the software itself. Paper instructions must still be supplied free of charge within seven calendar days of a request, and every electronic version must exist in the required languages.
Yes. Under Article 19(1) it must be translated into the official Union language or languages required by the Member States in which the device is made available.
The official Union language or languages determined by the Member State where the field safety corrective action is taken, with content consistent across Member States unless a difference is justified.
A second qualified linguist with a medical background should revise every translation against the source. Your regulatory and clinical experts are best placed to approve terminology, ideally once in a shared glossary rather than in every document.
Get your device information ready for every market
If you are entering new EU markets, or your labels and instructions change with every update, tell us which devices and languages you need. We will review your current documentation and plan the translations around your markets and your change process.
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