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MDR harmonised standards are meant to reduce uncertainty and support consistent implementation of EU requirements. But there’s a recurring reality that catches teams late in the documentation cycle: “harmonised” does not mean “available in every EU language.” Even when a standard supports presumption of conformity under the MDR, the standard text, and the Commission documents that drive...
While some auditors may still take a different view, the fact is that AI can be used for translation within the regulatory framework established by the EU MDR/IVDR. In fact, this has been the case since 2017, when machine translation had already reached quality levels similar to those seen today with the large language models popularised by ChatGPT. The use of artificial intelligence in...
In recent years, an idea has repeatedly surfaced in the press and on social media: French is making a comeback among the world’s leading languages. In 2026, the figures are indeed spectacular: French now has 396 million speakers, 65% of whom live in Africa, along with 170 million learners worldwide. These figures are notably highlighted by the International Organisation of the Francophonie (OIF)...
The translation industry in Europe is entering a visible transition phase: traditional volumes are shrinking, AI is accelerating workflows and value is shifting towards review, specialisation and consultancy. This is one of the clearest messages from the ELIS 2026 report ( European Language Industry Survey ), based on 1,058 participants in 45 countries . In this article, we examine the key...
Artificial intelligence (AI) has dramatically accelerated progress in machine translation. However, outside the major “well-resourced” languages (English, French, Spanish, etc.), results can be inconsistent, or even deceptively convincing. This is particularly true for minority and regional languages, which often have limited corpora, multiple orthographic variations and fewer standardised...
AI is transforming audiovisual localisation through voice cloning, lip-syncing, script translation... But what are the risks for professionals, and what is the legal framework in Europe? Introduction [TOC] Audiovisual localisation is no longer merely an “extra” for distributing a film or series beyond its domestic market. It has become a strategic infrastructure: without linguistic and cultural...
Choosing a translation agency in a business context is not about “buying words”. In multilingual projects, quality depends as much on language skills as on organisation: project management, terminology consistency, quality checks, security and a defined strategy for integrating (or not) AI-based translation. This guide is intended for marketing, product, legal, regulatory, localisation and...
At AbroadLink Translations, we are delighted to announce the validation of our ISO 9001 , ISO 17100 and ISO 13485 certifications for 2026. This milestone highlights our ongoing commitment to quality standards , accuracy and compliance in multilingual projects, particularly in life sciences and medical devices . This validation comes after an external surveillance audit carried out by Bureau...
When handling multilingual technical documentation (IFUs, labelling, technical sheets, clinical materials…), accurate translation alone is not enough. The distinction between a well-controlled corpus and one that is inconsistent from one language to another lies in a simple, yet frequently absent, tool: a style guide dedicated to regulatory translation. For PRRCs, QARA professionals and technical...
EUDAMED is the European database designed to centralise key information on medical devices, in a system intended for use across the EU ( official EUDAMED overview ). In this context, the Unique Device Identifier (UDI) is a cornerstone of device identification and traceability ( EU UDI page ) that manufacturers often need to manage in multiple languages. Remember: the first EUDAMED modules,...









