We are pleased to announce that Advena will be attending MEDICA this year. The event will be held in Dusseldorf Germany from the 16th to the 19th of November. Representing Advena at the event will be our Regulatory Consultant & Marketing Coordinator, Sam Attard. He will be present throughout the four days of event and … Read more
The Medical Device Coordination Group (MDCG) has updated its guidance on the classification of in vitro diagnostic medical devices (IVDs) under Regulation (EU) 2017/746 (IVDR). The guidance provides clarification on the application of the classification rules set out in Annex VIII of the IVDR and is intended to support the consistent classification of IVDs across … Read more
For manufacturers of Class C In Vitro Diagnostic (IVD) medical devices, September 26, 2026, is a critical regulatory milestone. Under the EU In Vitro Diagnostic Regulation (IVDR), manufacturers of legacy Class C devices must have a signed written agreement in place with an EU Notified Body by this exact date to maintain European market access.
Earlier this month, Advena proudly attended the 10th annual conference of the European Association of Authorised Representatives (EAAR) in Brussels. This important event brought together a diverse group of stakeholders, including members of the European Commission for Medical Devices, Competent Authorities, Notified Bodies, manufacturers, and EAAR members. The conference provided a valuable platform for discussing … Read more
The National Standards Authority of Ireland (NSAI) has announced its decision to divest its medical-device department to an established testing, inspection and certification (TIC) organisation. The announcement has raised important questions for manufacturers holding CE certificates issued by Notified Body 0050 (NSAI), as well as companies holding NSAI ISO 13485 or Medical Device Single Audit … Read more
ISO 10993-3:2026 was officially published in August 2026 as the fourth edition of the standard. The updated standard addresses the biological evaluation of medical devices with respect to genotoxicity, carcinogenicity, reproductive toxicity, and developmental toxicity. ISO 10993-3 provides manufacturers with strategies for evaluating these potential biological risks where they have been identified as relevant to … Read more
A new consolidated version of the MDR has recently been published. The new version incorporates the following delegated regulations: The new consolidated version of the MDR can be accessed using the following link
The EU Commission has recently published videos from the third EMDN Training. To offer some background to this training module, the third training provided an overview of the evolving role of the EMDN, with particular focus on its practical use throughout the device lifecycle. It covered the application of the nomenclature in regulatory activities, practical … Read more
We are pleased to announce that Advena will be attending the MDR/IVDR Summit hosted by EAAR in Brussels from the 8th to 9th September. Representing Advena at the event will be our Business Administration Supervisor, Polina Sobolevskaia. She will be present throughout the two days of the summit and will be available on the show … Read more
The European Commission has published two delegated acts in the Official Journal of the European Union (OJEU) introducing additional well-established technologies (WET) under the Medical Devices Regulation (MDR). Well-established technologies are generally considered to be relatively simple medical devices with stable and widely accepted designs, well-documented safety and clinical performance, and a long history of … Read more
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