EU MDR language requirements for medical device videos

A US device company preparing for its first EU launch usually has a folder of English videos: a procedure animation, a setup tutorial, a booth loop, a few sales training modules. Someone asks which ones need to be translated, and for which countries. The answer is rarely "all of them, into everything," and it is rarely "none."

The EU Medical Device Regulation (MDR) does not have a chapter on video. It has rules for the information that accompanies a device, rules for claims, and a separate implementing regulation for electronic instructions for use. Each Member State then sets the languages. This guide shows how those pieces apply to the videos a device company actually makes, with a worked example and a checklist you can use on your own library this week.

Start by sorting each video into one of four buckets

The MDR language rule is attached to a specific set of information, not to a format. Article 10(11) requires manufacturers to ensure the device is accompanied by the information in Section 23 of Annex I "in an official Union language(s) determined by the Member State in which the device is made available." Section 23 covers the label and the instructions for use (IFU). The MDR defines the IFU as the information the manufacturer provides to inform the user of a device's intended purpose and proper use and of any precautions to be taken.

So the first question for any video is not "is it a video?" It is "what job does it do?" We sort every video in a library into one of these four buckets before anyone gets a translation quote.

The fourth bucket is where teams get surprised. A sales training module that walks through device setup step by step may end up being handed to hospital staff. Once it is used to teach proper use, your regulatory team may treat it as information supplied, and the language rules follow. Decide the bucket in writing, and keep the video's distribution consistent with that decision.

How the Member State language rules apply

The MDR leaves the choice of language to each country. To help manufacturers, the European Commission publishes an overview table of national language requirements under the MDR. The current version is Revision 3, dated August 2025. It splits each requirement into patient or lay users and professional users, and it covers the label and IFU, the implant card, the declaration of conformity, field safety notices, documents for conformity assessment and graphic user interfaces.

Here is the label and IFU column for a handful of countries, as the table states it.

*The table marks Italy as a country where recent information is not available.

Two practical points come out of that table. First, the professional-user column is often more flexible than the lay-user column. A video for surgeons in the Netherlands may be acceptable in English. The same video for patients is not. Second, Belgium is three languages for lay users, not one, which changes the subtitle plan for any patient-facing video sold there.

Electronic IFU: where video usually lives

Most use videos are delivered online, so the electronic IFU rules matter. Annex I, Section 23.1(f) allows instructions for use in a non-paper format only to the extent, and under the conditions, set by separate EU rules. The regulation named there, (EU) No 207/2012, has since been repealed by Commission Implementing Regulation (EU) 2021/2226, which was itself amended in 2025.

In the consolidated text, three provisions shape a video plan:

• Electronic IFU is allowed for devices intended for use by professional users. If lay use is reasonably foreseeable, the instructions intended for lay persons must be provided on paper.
• The electronic IFU must be available in all Member States where the device is made available, unless the risk assessment duly justifies otherwise. On the manufacturer's website, it must be in an official language of the Union determined by the Member State.
• Users can request a paper IFU at no additional cost, delivered within the period set in the risk assessment and at the latest within 7 calendar days.

The last point is easy to forget when a video carries real instructional content. A video cannot be printed. If your video shows a step or a warning that the written IFU does not, a user who asks for paper is missing something. Our rule of thumb: the written IFU stays complete on its own, and the video demonstrates it. That keeps the video a supplement and keeps translation scope predictable. Our post on turning an IFU into a training video walks through how to build a video that tracks the IFU line by line.

Promotional videos: Article 7 applies in every language

For launch, booth and website videos, the language rules above usually aren't the deciding factor. Claims are. MDR Article 7 prohibits text, names, trademarks, pictures and other signs that could mislead the user or patient about a device's intended purpose, safety and performance. It applies to labeling, the IFU, making the device available, putting it into service and advertising.

Article 7 gives four examples of what counts as misleading: ascribing functions or properties the device does not have; creating a false impression about treatment, diagnosis or the device's functions; failing to inform about a likely risk of using the device as intended; and suggesting uses other than the intended purpose assessed in conformity assessment.

Translation is where the fourth example sneaks in. A translator who doesn't know the approved intended purpose will pick the natural word, and the natural word can be broader. "Indicated for adults" becomes "for patients." A specific vessel becomes "blood vessels." Each change is small, and each one can widen the claim. National advertising and language laws can also apply to promotional material, so check with your local affiliate or distributor before a campaign runs. For the US side of the same question, see our guide to who regulates medical device advertising.

A worked example: one library, three countries

Fictional example. Harbor Point Surgical (a fictional company) is launching a Class IIb surgical stapling system in Germany, the Netherlands and Belgium. It is used only by trained surgical staff. The video library has five pieces. Here is how its team scopes them.

Notice what is not on the list: a patient video. If Harbor Point later adds one, the lay-user column applies, so Belgium alone would need French, Dutch and German.

A quick US footnote for Spanish-language versions

US teams sometimes plan a Spanish version of a labeling video at the same time as EU work. FDA's rule in 21 CFR 801.15(c) generally requires required label and labeling information in English, with an exception for articles sold only in Puerto Rico or a US territory where another language predominates. It also says that if a label contains any representation in a foreign language, the required information must appear in that language too, and the same applies to labeling. A Spanish voiceover that drops a warning the English version carries is a problem. Translate the whole required content, or don't translate.

A checklist before you request translation quotes

1. List every video and its bucketInformation supplied, user interface, promotional or internal. Get regulatory sign-off on the list.
2. Map buckets to countries and usersFor each launch country, note whether the audience is lay or professional and pull the label and IFU language from the Commission table.
3. Confirm the national textAsk regulatory or the local distributor to confirm each country's rule. The table is a guide, not the law.
4. Lock the English firstFinish claims review in English before translation. Every change after translation multiplies.
5. Give translators the intended purposeSend the approved intended purpose and a short glossary with the script so wording doesn't drift broader.
6. Review each language for claimsA bilingual reviewer checks each translated script against the intended purpose before any voice is recorded.
7. Keep the written IFU completeNothing safety-relevant should live only in the video.

Captions are usually the cheapest way to cover several languages for professional-use content, and recorded narration is worth it where the audience is lay or the setting is noisy. Our medical video localization work starts from exactly this kind of inventory.

General information about EU and US rules as of the date of this post, not legal or regulatory advice. Language requirements depend on the device, its users and each country's law, so confirm the plan with your regulatory team.

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