Embedded Files
In accordance with the EU harmonization legislation, external CE documentation intended for the user or authorities must be translated into the local language of the Member State where the product is placed on the market. Internal documents, such as the Technical File, generally do not require translation unless specifically requested by national authorities.
In accordance with the EU harmonization legislation, external CE documentation intended for the user or authorities must be translated into the local language of the Member State where the product is placed on the market. Internal documents, such as the Technical File, generally do not require translation unless specifically requested by national authorities.
External Documents (Translation Mandatory)
External Documents (Translation Mandatory)
The following must be translated into the official language(s) of the EU Member State where the product is sold:
Instructions for Use / User Manuals: Required by almost all directives (e.g., Machinery Regulation 2023/1230, LVD 2014/35/EU) to ensure user safety.
Safety Information & Labels: Warnings on the product or packaging must be localized per the General Product Safety Regulation (GPSR) 2023/988.
EU Declaration of Conformity (DoC): Must be provided in the language required by the Member State (Blue Guide 2022; RED 2014/53/EU).
Internal Documents (Translation Not Mandatory)
Internal Documents (Translation Not Mandatory)
Technical Documentation (Technical File): Includes test reports and design data. Under standard EU rules (e.g., EMC Directive 2014/30/EU), this can remain in English.
Exception: You only provide translations for specific parts if a national authority formally requests them during an investigation.
recommended Translation Agencies for CE Documentation
recommended Translation Agencies for CE Documentation
Technical & Regulatory Specialists
Technical & Regulatory Specialists
M21Global: Specializes in technical manuals and Declarations of Conformity.
PoliLingua: Focused on IFUs, labeling, and packaging localization.
Milestone Localization: ISO-certified for CE-specific regulatory compliance.
Medical Device (MDR/IVDR) Specialists
Medical Device (MDR/IVDR) Specialists
Novalins: Uses medical/scientific experts for high-precision clinical documentation.
TransPerfect: ISO 13485 certified for global medical device labeling and safety data.
Enterprise & Large-Scale Providers
Enterprise & Large-Scale Providers
AD VERBUM: High-volume specialist for cross-border regulatory filings.
RWS: Global leader in technical documentation and intellectual property.
Acolad: Extensive European footprint for multi-language manual translation.
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