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Last entries
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...
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...
16/10/2025
AbroadLink News, Medical devices
AbroadLink takes part in the 2025 Rentrée du DM for the first time: expert translation and commitment to quality at the core of the medical device sector. [TOC] AbroadLink at the Rentrée du DM in Besançon: a strategic debut in Bourgogne-Franche-Comté For the first time, AbroadLink took part in the unmissable autumn event for the medical device sector: the Rentrée du DM , held in Besançon, at the...
02/10/2025
AbroadLink News, Medical devices
Translation under the MDR and IVDR has become a pivotal issue for manufacturers of medical devices and in vitro diagnostics. This is precisely the topic discussed in the webinar “Translation Under the MDR and IVDR: What a PRRC/QARA Should Know!” , organised by Team-PRRC in collaboration with AbroadLink . This event brought together industry professionals to share practical insights on regulatory...
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 ...