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22/05/2026
Medical devices
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...
15/05/2026
Medical devices
Your IFU Is Translated. But Are Your Complaints Being Understood Correctly? After launch, your most decision critical inputs rarely arrive as controlled documents. They arrive as multilingual Post-Market Surveillance (PMS) data for medical devices : complaint narratives, distributor field reports, service notes, user support emails, local hospital feedback, and app reviews for software medical...
28/04/2026
Medical devices
We have already discussed this in numerous blogs: translation within the framework of EU MDR Regulation 2017/745 on medical devices is not merely a final step. It is a key element of compliance, closely linked to user safety, as it directly affects the content of the documentation supplied with a medical device. This is precisely why ISO 13485 certification makes sense for a translation agency:...
22/04/2026
Medical devices
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...
18/03/2026
Medical devices, International Marketing, Translation
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...
16/03/2026
Medical devices
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,...
13/03/2026
Medical devices, AbroadLink News
From 5 to 8 May 2026 , the European regulatory affairs community will gather in Lisbon for RAPS Euro Convergence (with pre-conference workshops on 5 May). Programme and official event information . Following our debut at RAPS Euro Convergence 2025 in Brussels , we will return as sponsor and exhibitor at this must-attend event. Our goal is to connect with manufacturers, start-ups, RA/QA...
27/02/2026
Medical devices
Last week, my wife (a medical student) was preparing for a multiple-choice exam in general physiology (1st year of medicine). To save time, she tried to use ChatGPT. The experience was frustrating: on many occasions, the answer changed depending on how she asked the question. Then, she turned to Google. In her opinion, it was more accurate. Even so, she found mistakes and contradictions. In the...
25/02/2026
Medical devices, Translation
For a medical device manufacturer, the information provided to users is no longer delivered solely through IFUs. The same content, or content that is supposed to be the same, can be found on the website, in marketing brochures, in conference materials, in PDF files sent to distributors, and even on social media. As each team —marketing, digital, sales, regulatory— adds its own touch, consistency...
20/02/2026
Medical devices, Translation
Following on from our previous article on what it means to have accurate, up-to-date translations that are faithful to the master version , this article describes how to manage local adaptations without compromising compliance. At first glance, adapting instructions for use (IFUs) to a local market may appear to be nothing more than a simple language localisation task. However, under the MDR and...