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 E
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 the European Union.
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.
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.
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.
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.
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.
The MDCG PMS and Vigilance Working Group released the draft Trend Report Form and guidance documents: HERE
These documents, along with the meeting minutes, were uploaded last week.
Too few Notified Bodies in Europe despite the increase in CE marking applications. Analysis of the 2021-2025 figures and outlook up to 2028.
EUDAMED, the European Database on Medical Devices, is expected to become mandatory starting Q1 2026 (followed by a transition period): HERE
