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.”
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.
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.
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).
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.
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.
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 quickly becomes a challenge.
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.
For medical device manufacturers, PRRCs and QARA teams, the requirements of Regulation (EU) 2017/745 (MDR) for IFUs, labelling and accompanying documentation go beyond simply “having the correct translation”. The Regulation stipulates that the information supplied by the manufacturer must be understandable, consistent and kept up-to-date in the languages required by each Member State.
This article follows on from the one published on 29 January regarding the “ European Commission’s proposal for revising EU MDR and IVDR: Key points” (January 2026) and the effects that amending this proposal woul
