EU MDR 2017/745

Language and Translation Requirements of the Medical Device Regulation

Overview of EU MDR 2017/745 and Its Language Requirements

Regulation (EU) 2017/745 on medical devices – commonly known as the EU MDR – has been fully applicable since 26 May 2021, replacing the former Directives 93/42/EEC (MDD) and 90/385/EEC (AIMDD). One of the MDR's central requirements concerns the provision of information in the language of the user, particularly for Instructions for Use (IFU).

Why the Language Requirements Were Tightened

Under the MDD, language requirements were less explicitly formulated. The MDR has closed this gap by clarifying in Article 10(11) that the information referred to in Annex I Chapter III must be provided in the official language(s) determined by the Member States. This tightening reflects the recognition that comprehensibility is a core aspect of product safety.

Scope of the Translation Obligation

The translation obligation covers not only the Instructions for Use in the narrow sense but all information supplied with the device: labels, package inserts, warnings, markings on the packaging, and where applicable, implant cards. Manufacturers distributing their devices in multiple EU Member States must therefore establish comprehensive translation management.

Requirements for Translation Quality

The MDR does not merely require the existence of a translation but implicitly also its quality. The information must be "clearly understandable" – an indeterminate legal concept that in practice means the translation must be technically accurate, terminologically consistent, and appropriately worded for the target audience (healthcare professionals or lay users).

Notified Bodies spot-check translations during conformity assessment and may demand improvements. Market surveillance authorities of the Member States also have the power to verify language compliance.

Specific Challenges in IFU Translation

The translation of medical device Instructions for Use differs fundamentally from general technical translation. Manufacturers face specific challenges:

- **Terminological consistency**: Medical terminology must be used uniformly and in conformity with the standards applicable in the target language. - **Regulatory compliance**: Certain formulations are subject to legal requirements, such as warnings and contraindications. - **Version control**: When products are modified, all language versions must be updated synchronously. - **Layout adaptations**: Some languages require significantly more space (e.g. Finnish or Hungarian), which affects the document layout.

Transitional Provisions and Current Enforcement

The MDR provides transitional provisions in Article 120 that allowed manufacturers to continue placing devices on the market under the MDD under certain conditions. These transitional periods have now expired for most product categories. Full enforcement of the language requirements falls to the national market surveillance authorities, who are increasingly conducting spot checks. The Medical Device Coordination Group (MDCG) in particular has emphasised in its guidance documents that language requirements are not a formality but a safety-relevant requirement.

The Role of Translation Management Software

Given this complexity, an increasing number of manufacturers are adopting specialised translation management systems. Such tools help maintain terminology databases, leverage translation memories, document approval workflows, and ensure traceability of all changes. Particularly for product families with numerous variants and accessories, the translation effort can quickly encompass hundreds of documents in dozens of languages. Without a systematic tool, it is virtually impossible to guarantee the consistency and currency of all language versions.

ManualWorks was developed specifically for the requirements of the medical device industry and combines these functions in a regulatory-compliant platform. Through automated workflows, integrated terminology checking, and complete audit trails, ManualWorks helps manufacturers fulfil the MDR language requirements efficiently and with full traceability.

Summary

The EU MDR 2017/745 has significantly tightened the language requirements for medical devices. Manufacturers must provide the Instructions for Use and all accompanying information in the official languages of their respective target markets. Translation quality is not optional – it is a regulatory imperative and a critical factor in product safety. An early investment in professional translation processes and suitable software tools pays off in the long run – both in terms of compliance and time to market.

Frequently Asked Questions