Glossary

An IFU (Instructions for Use) is the document accompanying a medical device that contains all information necessary for its safe and intended use. It is a mandatory component of product labelling under the EU MDR (Regulation (EU) 2017/745) and must include information on intended purpose, safety warnings, contraindications, and usage instructions. The IFU must be provided in the official language of each target market.

The intended purpose, as defined in EU MDR Article 2(12), is the use for which a medical device is intended according to the data supplied by the manufacturer on the labelling, in the instructions for use, or in promotional or sales materials. It forms the basis for the classification of the product and is decisive for the evaluation of safety and performance. The intended purpose must be precisely formulated and must identify all intended clinical applications, target populations, and conditions of use.

The technical documentation is the comprehensive compilation of all documents that demonstrate the conformity of a medical device with the requirements of the EU MDR. Its content is described in detail in EU MDR Annex II and III and includes, among other elements, the product description, intended purpose, design and manufacturing information, general safety and performance requirements, risk management, clinical evaluation, labelling, and instructions for use. It must be kept up to date throughout the entire lifecycle of the product.

Signal words are normatively defined terms used in safety and warning notices to indicate the severity of a hazard. According to ISO 3864 and the harmonised standard ANSI Z535, four levels are distinguished: DANGER (immediate hazard that will result in death or serious injury), WARNING (potentially hazardous situation that could result in death or serious injury), CAUTION (potentially hazardous situation that could result in minor or moderate injury), and NOTICE (important information without a direct safety reference, e.g. for product protection). In medical device instructions for use, signal words are essential as they enable users to make an immediate risk assessment.

An eIFU (electronic instructions for use) is the digital provision of a medical device's instructions for use instead of or in addition to the printed paper version. The legal basis is EU Regulation 207/2012, which was updated by Regulation (EU) 2021/2226 in the course of alignment with the EU MDR. An eIFU can be provided via a manufacturer's website, through access information on the product or packaging (e.g. URL, QR code), or through integrated software displays. The manufacturer must ensure that the eIFU remains available for the entire expected lifetime of the product and is provided in all required language versions.

The UDI (Unique Device Identification) is a globally harmonised system for uniquely identifying medical devices. It consists of a UDI-DI (Device Identifier) that identifies the product and manufacturer, and a UDI-PI (Production Identifier) that encodes production-related data such as batch number or expiry date. The UDI system is a key component of the EU MDR and is managed through the EUDAMED database.

The EU MDR (Regulation (EU) 2017/745) is the European Medical Device Regulation that has been fully applicable since May 2021, replacing the former Directive 93/42/EEC (MDD). It establishes comprehensive requirements for the safety, performance, clinical evaluation, and surveillance of medical devices. The regulation applies directly in all EU Member States and tightens requirements for labelling, traceability, and clinical evidence, among other areas.

The IVDR (Regulation (EU) 2017/746) is the European regulation on in vitro diagnostic medical devices, applicable since May 2022, replacing the former Directive 98/79/EC. It introduces a risk-based classification system with four classes (A to D) and imposes stricter requirements for clinical performance evaluation, technical documentation, and post-market surveillance. Like the EU MDR, it requires the provision of instructions for use in the official languages of target markets.

A Notified Body is an organisation designated by a national authority and notified by the EU Commission to carry out conformity assessment procedures for medical devices. It reviews technical documentation, conducts quality management system audits, and issues EU conformity certificates that are a prerequisite for CE marking. Under the EU MDR, Notified Bodies themselves are subject to strict designation and monitoring requirements.

Conformity assessment is the process by which it is demonstrated that a medical device meets the applicable regulatory requirements of the EU MDR or IVDR. Depending on the risk class of the product, it involves an internal assessment by the manufacturer and/or an assessment by a Notified Body. The procedure includes review of technical documentation, the quality management system, and the clinical evaluation. Upon successful completion, the manufacturer may affix the CE marking.

The risk class determines the regulatory requirements that a medical device must meet and is established based on the classification rules set out in EU MDR Annex VIII. The EU MDR distinguishes four risk classes: Class I (lowest risk), Class IIa, Class IIb, and Class III (highest risk). Classification is based on factors such as duration of use, degree of invasiveness, and the body part concerned. Higher risk classes require more comprehensive conformity assessment procedures involving a Notified Body.

EUDAMED (European Database on Medical Devices) is the central European database for medical devices established under the EU Medical Device Regulation (EU MDR 2017/745). It serves as a comprehensive information system for the registration of economic operators and products, the management of UDI (Unique Device Identification) data, the documentation of conformity assessments by Notified Bodies, the recording of vigilance reports, and post-market surveillance. Its goal is to increase transparency and improve market surveillance throughout the European Economic Area.

A Translation Memory (TM) is a database that stores previously translated text segments (source-target text pairs) and suggests them for reuse in future translation projects. When a new segment matches a stored entry (100% match) or shows high similarity (fuzzy match), the existing translation is proposed. TMs are a core component of modern CAT tools and contribute significantly to terminological consistency, time savings, and cost reduction.

A CAT tool (Computer-Aided Translation tool) is software that supports professional translators by segmenting texts and providing features such as translation memory, terminology management, quality assurance checks, and project management. Unlike machine translation, a CAT tool does not produce automatic translations but rather enhances the productivity and consistency of the human translator. Common CAT tools include SDL Trados, memoQ, and Across.

Terminology, in the translation context, refers to the systematic capture, management, and maintenance of technical terms and their approved translations in a terminology database. Consistent terminology ensures that identical concepts are rendered with the same terms across all language versions of a document. In the medical device sector, this is particularly critical, as ambiguous or inconsistent terms can lead to use errors and safety risks.

IFU localization refers to the comprehensive process of linguistically, culturally, and regulatorily adapting instructions for use (IFU) to a specific target market. Unlike pure translation, which is limited to linguistic transfer, localization takes into account country-specific standards (e.g. national deviations in harmonised standards), conventions for units of measurement, number formatting and date formats, market-specific regulatory requirements, cultural differences in the perception of warnings and safety information, and typographic and layout requirements of different writing systems. Localization ensures that the instructions for use are not only linguistically correct but also fully comprehensible and regulatorily compliant in the target market.

Usability, in the context of medical devices, refers to the characteristic of a user interface that enables effective, efficient, and satisfactory use under the intended conditions of use. The harmonised standard IEC 62366-1 describes the usability engineering process aimed at identifying and minimising use errors. The user interface also includes accompanying documents such as instructions for use, whose comprehensibility and clarity directly contribute to safe use.

Traceability refers to the ability to trace the history, application, or location of a medical device throughout the supply chain. Under the EU MDR, this is ensured through the UDI system, the EUDAMED database, and post-market surveillance requirements. In a broader sense, traceability also encompasses the complete documentation of all process steps within the quality management system, including the creation and maintenance of accompanying documents.

Validation is the documented evidence that a process, system, or method reliably and reproducibly delivers the intended results. In the context of the medical device industry, this includes process validation according to ISO 13485, validation of software (including CAT tools and translation management systems), and validation of individual translation outputs through defined review and approval procedures. Validation differs from verification in that it demonstrates suitability for the intended use.

Post-Market Surveillance (PMS) refers to the systematic and proactive process of collecting, recording, and analysing experience data on medical devices already available on the market. Under EU MDR Articles 83–86, manufacturers must establish a PMS system covering vigilance reports, customer feedback, post-market clinical follow-up data (PMCF), and trend analyses. The results feed into the PMS report or the Periodic Safety Update Report (PSUR) and may trigger updates to the risk analysis, technical documentation, and instructions for use.