IFU Translation for Orthopedics & Rehabilitation

Patient-friendly translations for prosthetics, orthotics, and rehabilitation devices

Orthopedics and Rehabilitation: Where patient safety meets comprehensibility

Orthopedic medical devices and rehabilitation equipment hold a distinctive position within medical technology. Unlike implants or diagnostic devices used exclusively by medical professionals, prosthetics, orthotics, braces, and rehabilitation devices are in the majority of cases used directly by patients — often in the home environment, without immediate professional supervision. This characteristic has far-reaching consequences for the creation and translation of instructions for use.

The regulatory classification of orthopedic products

EU MDR 2017/745 classifies orthopedic products into different classes depending on their application and risk. Simple braces and elastic supports typically fall under Class I, while custom-made prostheses and motorized rehabilitation devices are classified as Class IIa or IIb. Classification rules 1, 9, and 12 of Annex VIII are particularly relevant here. Different documentation requirements — and consequently different translation requirements — apply to each risk class tier.

Regardless of risk class, Article 10(11) of the MDR requires that all information pursuant to Annex I Chapter III be provided in the official language of the respective Member State. For manufacturers with broad product portfolios — from simple knee braces to microprocessor-controlled leg prostheses — this means substantial translation volumes that must be organized efficiently.

The challenge of patient-facing communication

Annex I, Section 23 of the MDR establishes a key requirement: information provided to the user and, where appropriate, the patient must be written in language that is easily understood by the intended users, taking into account their level of training and knowledge. For orthopedic products that patients don and adjust themselves, this requirement is particularly demanding.

The instructions for use of a lower-leg orthosis, for example, must provide the orthotist with technical specifications — material composition per ISO 22523, load limits, adjustment parameters — while also explaining to the patient in comprehensible language how to correctly don the orthosis, what skin reactions may occur, and when to consult a physician. This dual requirement must be met equally in each of up to 24 official EU languages.

Terminological complexity in orthopedics

Orthopedic specialist terminology is internationally standardized through the ISO 8549 series (Prosthetics and orthotics — Vocabulary). However, clinical practice in many countries deviates considerably from normative terminology. Anatomical directional terms, biomechanical functional descriptions, and material science terms must be translated not only correctly but also in a manner that is established within the local care context in each target language.

A concrete example: the German term "Vorfußentlastungsschuh" (forefoot offloading shoe) is well established in German orthopedic practice but has no direct equivalent in many languages. The translation must accurately convey both the functional aspect (forefoot offloading) and the product category (therapeutic shoe) in the respective target language without distorting the clinical context.

How manualworks optimizes orthopedic IFU translation

manualworks addresses the specific challenges of the orthopedics and rehabilitation industry through three core capabilities: first, dual-register terminology management that maintains technical language and patient language in parallel; second, country-variant management that accommodates local care standards and terminology differences within a single language; third, modular text block management that centrally maintains cross-product safety notices and consistently inserts them into all instructions for use.

For manufacturers with broad product portfolios, manualworks additionally provides the ability to organize products by risk class and adapt the review workflow accordingly. Class I products undergo a streamlined process, while Class IIb products require the full, auditable workflow with terminology verification and four-eyes review. This scales the translation process efficiently without compromising regulatory compliance.

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