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
We’re pleased to announce that this edition of the newsletter as well as future editions will also be available in a video summary format, offering a convenient way to catch up on the latest regulatory updates. To watch the full video summary for the month of July, please click on video below.
The Medical Device Coordination Group (MDCG) has published a new position paper addressing the assignment of Unique Device Identifiers (UDIs) between manufacturers and distributors. The position paper was issued in response to a common practice whereby distributors assign their own Basic UDI-DIs and UDI-DIs under their own brand name and obtain these identifiers directly from … Read more
The European Commission has recently updated its list of the standard fees charged by EU Notified Bodies. The revised list includes the fees of Notified Bodies that have been designated since the previous publication, such as Malta Conformity Assessment (MCA). The updated list provides manufacturers with a useful reference for comparing the standard fee structures … Read more
Earlier this month, we had the opportunity to visit WHX Osaka in Japan. As this was our first visit to the country, it provided an excellent opportunity to experience firsthand the innovation and technological advancements emerging from the Japanese medical device industry. The exhibition also gave us the pleasure of meeting many of our existing … Read more
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