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Last entries
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...
18/02/2026
Medical devices, Translation
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. The purpose...
05/02/2026
Medical devices
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 would have on the language aspect of the development of medical devices. Translation processes for medical devices have now taken on strategic importance, going far beyond a simple...
29/01/2026
Medical devices
The European Commission has published a far-reaching proposal to revise the MDR 2017/745 on medical devices and IVDR 2017/746 on in-vitro diagnostic medical devices , with the stated aim of simplifying the system, reducing burden and improving availability of devices in Europe, while keeping a high level of patient safety. [TOC] What Does the New EU MDR and IVDR Revision Proposal Mean for...
26/01/2026
Medical devices
The European Commission has published a draft Implementing Regulation on the uniform application of requirements for notified bodies under the MDR and IVDR . At first glance, this may sound like a technical or procedural update. In reality, it is a significant regulatory initiative that directly affects how medical devices and IVDs are certified, how long this takes, and how much it costs across...
22/01/2026
Medical devices
Navigating the European Union Medical Device Regulation (MDR 2017/745) means mastering the alphabet soup of MDR acronyms. If you’re a medical device manufacturer navigating the EU MDR (Medical Device Regulation) , you’re already aware that the regulation is packed with acronyms. These acronyms are crucial for compliance, but they can be challenging to decipher, especially when you need to...
15/01/2026
Medical devices
For years, EUDAMED has been “the great European database” that everyone is talking about in the medical device sector. Commission Decision (EU) 2025/2371 , published on 27 November 2025, marks a decisive step for the database, as four key modules are officially declared functional, triggering the countdown to mandatory use across the European Union . For manufacturers, their QARA teams, their...
20/11/2025
Medical devices
Context and main objective of the MDR and IVDR regulations Since their adoption in 2017, the European MDR (2017/745) and IVDR (2017/746) regulations have had a major impact on the regulatory landscape for medical devices and in vitro diagnostics. Their main objective? To enhance patient safety, ensure market transparency, and modernise compliance requirements for health technologies. Difficulties...