Have a package insert translated into German
Package leaflets, product information texts and instructions for use that carry approval and market access – safety-relevant information rendered faithfully, terminology-managed.
With package leaflets and product information, language is approval-relevant – not a word may deviate
Whether medicinal product or medical device: we translate package leaflets, product information texts and instructions for use, terminology-managed, into every required official language – active ingredient, dosage, contraindications and warnings stay faithful, while the regulatory release is owned by your team.
For marketing authorisation holders and regulatory affairs: QRD-compliant and faithful
The product information is part of the marketing authorisation – the BfArM and the EMA review it too. We translate along the EMA QRD templates, so that the structure and standard wording of the target language are preserved.
Do you translate along the EMA QRD templates?
Yes. For centrally and nationally authorised medicinal products we work with the EMA’s QRD (Quality Review of Documents) templates, so that the structure, headings and prescribed standard sentences of the respective language version are adopted exactly.
Do dosage, contraindications and side effects stay faithful?
Safety-relevant information – dosage, contraindications, warnings and side effects – we render faithfully and without interpretive latitude, because any deviation counts as a substantive change to the product information.
Do you use MedDRA for adverse-reaction terminology?
Yes – side effects and clinical pictures we render in the applicable MedDRA terminology, so that the information matches the regulatory standard language and stays evaluable in pharmacovigilance.
Who owns the regulatory release of the texts?
The substantive and regulatory release is owned by your team. We secure linguistic accuracy, terminological uniformity and QRD compliance and document changes traceably.
For medical device manufacturers and export: MDR-compliant into every official language
For medical devices, language is part of conformity. The notified body checks whether the instructions for use and labeling are complete in the language of the country of supply.
What language requirements does the MDR place on IFU and labeling?
The EU Medical Device Regulation MDR (Regulation (EU) 2017/745) requires the instructions for use (IFU) and labeling in the local language of every country of supply; the notified body checks completeness and consistency in the conformity assessment procedure.
Does the GPSR additionally apply to consumer products?
For products that are not medical devices, the EU Product Safety Regulation GPSR (Regulation (EU) 2023/988, applicable since 13 December 2024) requires safety and warning information in a language easily understood by the consumers of the target country.
How do you ensure that warning symbols and pictogram texts are correct?
We render the texts belonging to symbols and pictograms to standard and keep warnings, contraindications and application steps congruent across all language versions.
Do I need a certified translation for a package leaflet?
No. Package leaflets, product information and IFUs do not require court certification, but a technically and regulatorily exact professional translation. What is decisive is the local language, faithful safety information and terminological consistency.
For international market launch: consistent across languages and product variants
In a roll-out across several markets, consistency decides. We keep warnings and component designations identical across whole product families and all target languages.
How do you secure consistency across product families and series?
With a maintained glossary and a translation memory, warnings, contraindications, dosages and component designations stay uniform across all variants and languages – relevant under the MDR, because deviating wording counts as a substantive change.
Can you deliver many target languages in parallel?
Yes. For simultaneous launch in several markets we translate into all required official languages in parallel, coordinated by a dedicated project manager, with a single delivery date and a fixed price.
Do you handle updates for variants or new batches?
For text changes, new variants or updated safety information we translate only the deltas against the translation memory – faster, cheaper and without a break in the established terminology.
How your certified package leaflet translation works
Document and upload
Send your package insert as a PDF, photo or scan – we check legibility, stamps and intended use.
Fixed price in 120 minutes
You receive a binding fixed-price quote with a delivery date, clearly calculated in advance.
Professional translators and revision
Assignment to a subject-matter translator; independent revision under the four-eyes principle per DIN EN ISO 17100.
Delivered certified
Digital advance version and, on request, the certified copy by post – officially recognised.
Translate a package insert: German, English, French, Turkish, Spanish and over 60 languages
Whether for an authority, court, employer or university at home or abroad: we produce translations of package inserts, IFUs and labelling in German, English, French, Spanish, Italian, Turkish, Arabic and over 60 further languages. Translation is carried out exclusively by native-speaker translators with the relevant background; every version is revised under the four-eyes principle in accordance with DIN EN ISO 17100 and certified on request – recognised by authorities and courts.
How your fixed price for the package leaflet translation is calculated
We bill transparently by standard line (55 characters including spaces) from €0.95. The binding fixed price depends on volume, language combination, certification and the desired quality level – with no hidden costs and usually within about two hours.
Translating a package insert – frequently asked questions
Do you translate in an MDR-compliant way?
We translate terminology-guided and consistently for the requirements of the MDR; regulatory approval is your team's responsibility.
Do warnings remain true to the wording?
Yes – we render contraindications, warnings and dosages faithfully and in accordance with the standard.
Can you do many languages in parallel?
Yes – for product families we deliver consistent translations in several languages with shared terminology.
What does it cost?
From €0.95 per standard line; for series and repetitions, TM discounts apply – as a fixed price in advance.
What language requirements does the MDR set for package leaflets and IFUs?
The EU Medical Device Regulation MDR (Regulation (EU) 2017/745) requires instructions for use and labelling in the national language of the respective country of supply; the notified body checks completeness and consistency in the conformity assessment procedure. We translate in a terminology-driven way and transfer warnings true to the wording.
How is consistency ensured across product families and series?
With a translation memory and a maintained glossary, warnings, contraindications, dosages and component designations remain uniform across all variants of a product family and across multiple languages. This is relevant under the MDR, because deviating formulations count as a change of content.
Translation safe for approval and product
With product information, every safety-relevant word determines approval and liability. Alongside package leaflets and professional product information we translate Study documents, medical Doctor's letters and findings as well as technical Instructions for use and manuals – terminology-driven and regulatorily consistent. More on this in the practice area Medical translation.