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If you are looking for a translation agency for your company, the real challenge is not finding one, but rather minimising risk (quality, deadlines, compliance, confidentiality) and ensuring scalability. This guide outlines key selection criteria, an objective evaluation matrix and a list of translation agencies by speciality . [TOC] Practical criteria for comparing agencies Specialisation...
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...
The global translation industry is in the middle of its biggest disruption since the arrival of last generation of CAT tools. Language service providers, publishers and in-house teams are all asking the same question: what does artificial intelligence really change – and how fast? Market studies show that the wider language services industry was worth roughly USD 72 billion in 2024, after mid-...
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...
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...
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...
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...
In 2025, AbroadLink strengthened its position as a leading translation company specialising in the medical and MedTech sectors in Europe . In a context marked by the surge in publicly accessible AI translation tools, we not only maintained our position but also increased our turnover . This growth demonstrates that beyond technology, human added value, expertise, and quality remain decisive...
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...
Amid international growth and European regulatory requirements (such as Regulation (EU) 2017/745 on medical devices), many companies, particularly those operating in the medical sector, must ensure that all their documentation is available in the official languages of the countries where they intend to market their products. If you are considering expanding into the Irish market, translating into...









