Market access · Product information · Localisation
Language requirements for IFUs and labels
One device. Several users. Different national rules.
The MDR and IVDR establish the principle, but each Member State determines which languages it accepts. A compliant language strategy must connect the market, the intended user and every information channel.
Build the language logic ↓label · IFU · UI · card
Member State
Professional / lay
IFU / label / GUI
with documented conditions
Language is a market-access decision, not a final translation task
The central rule
There is no single EU language list
The manufacturer must use the language or languages accepted by the Member State where the device is made available. The requirements can change with the user group, the information type and whether the product falls under the MDR or IVDR.
01
What the MDR and IVDR actually require #
Under Article 10(11) of the MDR, the manufacturer must provide the information specified in Section 23 of Annex I in an official Union language determined by the Member State where the device is made available. The information must also be clearly comprehensible to the intended user or patient.
The IVDR follows the same general principle. Article 10(10) requires the information specified in Section 20 of Annex I to be provided in a language determined by the relevant Member State.
These requirements apply to information such as:
- 01Labels
- 02Instructions for use
- 03Packaging information
- 04Safety information
- 05Information displayed by the device where it is necessary for correct and safe use
Implant cards are governed separately by Article 18 of the MDR. They do not apply to IVDs.
Where will the device be made available?
Who must understand the information?
Which document or interface is involved?
Including every condition attached to English use
The current country-specific rules are summarised in separate European Commission tables for the MDR and IVDR ↗. The tables are useful working references, but they are not legally binding. National legislation takes precedence, and the current requirements should always be verified.
02
Professional users and lay users are treated differently #
Many Member States distinguish between devices used by healthcare professionals and devices intended for patients or other lay users.
Professional users may be able to work safely with information in English, particularly where English terminology is established in the relevant medical field. Some countries therefore accept English labels or IFUs for professional-use devices, either generally or subject to specific conditions.
The same flexibility is rarely available for lay users. A patient cannot be expected to understand technical information in English simply because a healthcare professional would.
English may be accepted, but often only for defined users, settings or agreed conditions.
The applicable national language is normally required for safe and independent use.
The intended user stated in the device documentation is therefore central to the language strategy. A professional-use device and a home-use version of the same technology may require different translations.
03
When English may be used for professional devices #
According to the current Commission MDR table, English may be accepted for professional-use labels or IFUs in countries including Austria, Belgium, Cyprus, Estonia, Ireland, Malta, the Netherlands and Poland.
This does not mean that the same conditions apply in every country.
Austria · Belgium · Cyprus · Ireland · Malta · Netherlands · Poland
Estonia allows English, but professional users may request information in Estonian.
Germany permits English or another language understood by the user in justified cases.
Finland permits English for professional users, while information necessary for safe use must be available in Finnish and Swedish.
Other countries permit English only through more specific arrangements. Croatia may require agreement from the professional user. Denmark allows an exception upon request. Latvia requires the consent of the healthcare facility. Romania may require approval from the competent authority and written consent from the healthcare professional.
The IVDR table follows a similar pattern but contains separate rules for information accompanying an IVD, self-testing devices and near-patient testing devices. English may be accepted for an IVD used exclusively by professionals while the same country requires its national language for self-testing products.
Professional use may support an English-language strategy, but it never replaces the market-by-market check.
04
Language requirements for lay users and self-testing devices #
For MDR devices intended for lay users, national-language requirements are generally stricter. In the current Commission overview, Ireland and Malta are the main EU Member States where English can serve as the accepted language for patient or lay-user labels and IFUs without translation into another national language.
Ireland
Malta
Relevant national language or languages
The same principle applies to IVDs intended for self-testing. Even where English is accepted for laboratory or professional-use IVDs, self-testing instructions will normally require the national language because the test is performed and interpreted by a layperson.
Near-patient testing should be checked separately. Some countries treat it as professional use when the test is performed by trained healthcare personnel, while others impose additional language requirements.
05
Language requirements for implant cards #
Implant cards are subject to Article 18 of the MDR and have their own national-language rules.
The current Commission table identifies several Member States that accept English in addition to, or instead of, a national language:
English when it is the patient’s choice
Greek or English
Finnish, Swedish and English
English, or English and Irish
Maltese, English or both
Swedish or English
These examples should not be treated as a general EU exemption. In Germany, for example, the implant card must be in German.
Manufacturers should also distinguish between the implant card itself and the accompanying information supplied to the patient. The language requirements and practical format may not always be identical.
06
What about the software user interface? #
A graphical user interface is part of the information through which the user operates the device. Language must therefore be considered during usability engineering and risk management, not added as an afterthought shortly before market launch.
There is no single EU rule stating that every software interface automatically follows the same language requirements as the IFU. National approaches differ.
Professional or lay user
Safety impact of misunderstanding
Connection between interface and instructions
National GUI provisions
Some Member States expressly treat safety- or performance-related interface elements in the same way as label and IFU information. Others allow English for professional users or impose separate conditions. Some national legislation does not state a specific GUI language rule at all.
This does not make untranslated software automatically acceptable. The manufacturer still needs to demonstrate that the intended user can understand the interface and use the device safely. For lay-user software, translation into the relevant national language will normally be necessary.
07
Electronic IFUs do not remove the language requirement #
Providing an IFU electronically does not create a language exemption. Where an electronic IFU is permitted, it must still be available in the language or languages required for the relevant market and intended user.
Electronic instead of paper, where the applicable conditions allow it
The same market and user-language analysis still applies
The manufacturer must also comply with the conditions governing electronic instructions, including accessibility, risk assessment, website availability and provision of a paper copy where required.
08
Language of conformity-assessment documentation #
The language used for technical documentation and other conformity-assessment documents is governed separately from the language of information supplied to the user.
English is widely accepted by Notified Bodies and national authorities, but it is not automatically accepted everywhere or for every document. Some countries expressly permit English, while others require the national language or a language agreed with the Notified Body.
Label · IFU · GUI · implant card · FSN
Technical documentation · QMS · submissions
Connected records. Different language decisions.
Even within one conformity-assessment project, different rules may apply to technical documentation, QMS documentation, the EU Declaration of Conformity, certificates, field safety notices and information supplied to patients and users.
The manufacturer should agree the working language with the Notified Body before submitting the application. A blank or unspecified entry in a national overview should not be interpreted as automatic acceptance of English.
09
Building a practical language matrix #
The safest approach is to maintain a controlled language matrix for every product and market.
Member State where the device is made available
Professional, patient or other lay user
Required and accepted languages
Required and accepted languages
Applicable MDR language rule
Interface and displayed information
EU Declaration of Conformity language
Field safety notice language
Language accepted by the Notified Body
Approval, consent or justification for English
Legal source, date, owner and revision status
Translations should be managed as controlled documents. Changes to the source text, label, IFU or software interface should trigger an assessment of the affected translations.
The practical conclusion
The required language follows the market, user and information
The MDR and IVDR establish the general principle, but Member States determine the languages they accept. English is often possible for professional users and conformity-assessment documentation, but the conditions vary significantly between countries.
For lay users, self-testing devices and safety-critical software interfaces, national-language requirements are usually stricter.
Which language is required for this particular information, for this intended user, in this Member State?
Official sources
Language as part of market access
Build the language matrix before labels, software and IFUs are released
MDRC helps manufacturers connect product information, usability, target markets and regulatory documentation within one controlled localisation strategy.
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