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Last entries
20/11/2025
Medical devices
[TOC] 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...
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 ...
18/09/2025
AbroadLink News, Medical devices
At AbroadLink Translations, we are delighted to announce the successful renewal of our ISO 9001, ISO 17100, and ISO 13485 certifications. This achievement demonstrates our unwavering commitment to quality, accuracy, and compliance in Life Sciences translations, particularly in the highly regulated field of medical devices in Europe. [TOC] A Strong Commitment to Quality and Compliance For...
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...