The European Commission has released an updated version of the Manufacturer Incident Report (MIR) form (Version 7.3.1), which was previously last revised in 2019. This form serves as a standardized template that manufacturers can use to report incidents involving medical devices to the relevant competent authorities. The New MIR form becomes mandatory as from November … Read more
There has been a new notified body that has been designated under the IVDR. The notified body is from Norway. The details of this notified bodies can be seen below: More information about this notified body can be found using the following link
We are pleased to announce that Advena will be attending WHX Kuala Lumpur, formally known as Asia Health from 16th to 18th July. This marks our third visit to Southeast Asia, and we are looking forward to reconnecting with our valued clients in the region, as well as engaging with new prospective partners during this … Read more
As many of our readers may know, this May we had the pleasure of attending Hospitalar 2025 in São Paulo, Brazil — one of the largest and most influential healthcare trade fairs in Latin America. This marked our second visit to the event, and we are already looking ahead with great enthusiasm at the possibility … Read more
By 26thMay 2025, manufacturers of certain medical devices must ensure that the UDI carrier is correctly affixed to the device, label or packaging. These include: This deadline is a critical step in the full implementation of the Unique Device Identification (UDI) system, aimed at enhancing the traceability, safety, and post-market surveillance of medical devices across … Read more
The European Commission is hosting a free hybrid workshop in Stuttgart to support onboarding to EUDAMED, the EU’s database for medical devices. The event will guide stakeholders—such as economic operators, notified bodies, and national authorities—on meeting their obligations under the MDR and IVDR, particularly regarding EUDAMED’s mandatory modules (Actors, UDI/Devices, Notified Bodies and Certificates, Market … Read more
The EU Commission has published an AI Action Plan. This Communication sets out an ambitious plan of action to drive progress. Artificial Intelligence (AI) is only beginning to take root across key economic sectors, offering solutions to some of today’s most critical challenges. As the full impact of this technological transformation continues to emerge, Europe … Read more
Two new standards have been harmonised with the IVDR. Both standards are related to sterilization. The Implementing Decision can be accessed using the following link
There has been a total of 3 new notified bodies that have been designated under the IVDR. The notified bodies are from Belgium, Spain and Italy respectively. The details of these notified bodies can be seen below: These new additions bring the total number of notified bodies to 16. More information about these notified bodies … Read more
A new UK Approved Body has been designated. The mew UK Approved body is Eurofins E&E CML Limited and isbased in Ellesmere Port UK. The current list of UK Approved Bodies can be seen in the table below, that being said, please be aware that the list is always being updated. UK Approved Body Number … Read more
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