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Last entries
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...
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...