IFU Translation for Dental & Ophthalmology Devices
Transfer specialized terminology precisely into every target language
Dental and Ophthalmology: Two industries, one shared challenge
The dental and ophthalmology sectors are among the most highly specialized segments of the medical device industry. Both fields are characterized by sophisticated terminology that has historically diverged considerably between countries and language regions. For manufacturers bringing their products to the European market under EU MDR 2017/745, the compliant translation of instructions for use into up to 24 official languages presents a particular challenge.
The terminological landscape of dentistry
Dental terminology is characterized by remarkable diversity. While ISO 1942 (Dentistry — Vocabulary) defines internationally harmonized terms, clinical practice in many countries has established divergent designations. For instance, one and the same material may be named differently in Germany, Austria, and Switzerland — despite all three countries sharing the same language.
For the translation of dental product instructions for use, this means: a simple one-to-one translation is rarely sufficient. Translators must not only master the language but also know the local dental terminology. This is especially true for materials (EN ISO 22674 for metallic dental alloys, EN ISO 4049 for composites), instruments, and surgical procedures in implantology.
Ophthalmic devices: Highest precision in translation
Ophthalmology places similarly high demands on translation quality. Products such as intraocular lenses (IOLs), vitrectomy devices, or diagnostic instruments like fundus cameras and OCT systems require terminology that is both medically correct and clinically established in the respective target language. The ISO 11979 series for intraocular lenses defines product-specific requirements whose correct representation in every language is essential.
Particularly relevant is the translation of performance claims and optical specifications. Terms such as "modulation transfer function," "spherical aberration," or "aspheric design" have established technical translations in various languages that are not reliably covered by general translation tools. Errors in translating optical specifications can lead to incorrect orders and ultimately to suboptimal treatment outcomes.
The MDR requirement for patient information
One aspect that affects both dental and ophthalmology manufacturers is the MDR requirement for patient information for implantable products. Article 18 of the MDR requires that patients receive an implant card containing, among other things, the product name, lot number, and necessary precautions. This information must be written in language understandable to medical laypeople.
Translation must therefore serve two fundamentally different language registers: the technical instructions for use aimed at the dentist or ophthalmic surgeon and the lay-friendly patient information. Both documents must, however, be terminologically aligned — the product name, indication, and key safety information must be translated consistently.
manualworks: Specialized platform for terminologically demanding industries
manualworks was built for exactly this kind of terminological complexity. The platform enables the creation of differentiated terminology databases that can be structured by language, country variant, and product line. Standard references such as ISO 1942, ISO 11979, or EN ISO 22674 are stored directly in the terminology database, so every translation decision can be traced back to the relevant standard.
For manufacturers active in both the dental and ophthalmology sectors, manualworks offers the ability to manage both product lines in a centralized platform — with separate specialist terminology but shared regulatory text modules. The result is a consistent, efficient, and auditable translation process that meets the requirements of the MDR and the respectively applicable product standards.
Frequently Asked Questions
What specific terminological challenges exist for dental IFUs?+
The dental industry uses highly specialized terminology that varies considerably between countries. For example, dental materials such as composites, glass ionomer cements, or ceramics have different technical terms in various languages that differ from general medical terminology. manualworks solves this through industry-specific terminology databases that map terms according to ISO 1942 (Dentistry — Vocabulary) and EN ISO 22674 (Dental metallic materials).
How are ophthalmological standards like ISO 11979 considered in translation?+
Ophthalmic medical devices are subject to specific standards such as ISO 11979 (Intraocular lenses) and ISO 11987 (Ophthalmic instruments). manualworks allows standards-specific terminology to be stored in the database, so terms like "diopter," "intraocular lens," or "vitrectomy" are translated in compliance with standards in every target language. The system automatically verifies that translated terms match the stored normative terms.
Can dental and ophthalmology products be managed together in manualworks?+
Yes. manualworks supports the management of multiple product lines within an organization. Dental and ophthalmology products can be maintained in separate projects with their own terminology databases, while shared regulatory text modules — such as general MDR conformity statements or standard warnings — are reused across projects. This is particularly relevant for diversified manufacturers active in both segments.