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11/12/2025
Medical devices, Translation
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...
27/11/2025
AbroadLink News, Medical devices
[TOC] Medica 2025: an unmissable global event for professionals in the medical sector The Medica 2025 trade fair, held in Düsseldorf, once again brought together the world’s leading players in the healthcare sector. As a key reference for healthcare and medical technology professionals, this annual event hosted over 5,000 exhibitors and around 90,000 visitors from all over the world. From cutting...
10/11/2025
Medical devices
Too few Notified Bodies in Europe despite the increase in CE marking applications. Analysis of the 2021-2025 figures and outlook up to 2028. [TOC] Introduction: the paradox of growing demand versus limited supply Since the MDR and IVDR came into effect, all medical device manufacturers are required to go through Notified Bodies (NB). Each device or device family must be certified compliant with...
30/10/2025
AbroadLink News, Medical devices
AbroadLink takes part in the 4th TEAM PRRC Congress in Rome, reaffirming its support for PRRCs and medical device compliance across Europe. [TOC] What is TEAM-PRRC and what does it do? TEAM-PRRC is a European non-profit organisation founded in 2020, dedicated to the profession of “Person Responsible for Regulatory Compliance” (PRRC), as described in Article 15 of Regulation (EU) 2017/745 “MDR”...
23/10/2025
Medical devices
Discover the latest European regulatory developments (2025/1234) on e-IFUs and their impact on the translation of medical device user manuals. Manufacturers, PRRCs and QARA professionals: everything you need to know to maintain compliance. [TOC] 1. What is an e-IFU and what is the reason behind this regulatory change? Definition: e-IFUs (electronic Instructions for Use) are digital versions of...
22/09/2025
AbroadLink News, Medical devices
After our rewarding experience last year in Málaga , AbroadLink Translations is excited to announce our sponsorship and participation at the TEAM-PRRC 4th Annual Summit 2025 , taking place in Rome, Italy, on October 23–24, 2025 . This leading European regulatory affairs event has become a cornerstone for professionals working with medical devices, in vitro diagnostics, and MDR/IVDR compliance ...
11/08/2025
AbroadLink News, Medical devices
Every year, the MEDICA trade fair in Düsseldorf brings together the most influential stakeholders in the global medical industry. From 17 to 20 November 2025, more than 5,000 exhibitors and 80,000 professional visitors from 165 different countries are expected to attend. It is the ideal opportunity to present your innovations, forge strategic partnerships and enhance your brand's visibility in...
28/07/2025
Medical devices, Project Management
According to the EU Medical Device Regulation (MDR) language requirements , manufacturers must provide clear and localized Instructions for Use (IFUs) for each relevant market. While necessary for compliance, multilingual IFUs can represent a significant portion of the documentation budget, especially for companies operating across multiple jurisdictions. Below are five practical strategies to...
09/06/2025
Medical devices, Translation
One of the main objectives of Regulation (EU) 2017/745 on medical devices (MDR) is to enhance patient safety through a uniform market surveillance system. However, it is precisely in the application of these regulations where a significant problem arises: the conceptual ambiguity and confusion between the terms 'adverse event' and 'serious incident'. This terminological inconsistency is more than...