We are pleased to announce that Advena will be attending WHX Osaka, formally known as Japan Health from the 2nd to 4th July. This marks our first visit to Japan, and we are looking forward to reconnecting with our valued clients in the region, as well as engaging with new prospective partners during this prominent … Read more
The MDCG has updated the guidance document MDCG 2021-5 to include the addition of an appendix which aims to aid manufacturers transition to the new ‘EU REP’ symbol. The European Commission has confirmed a five-year transition period for the implementation of Amendment A1:2025 to harmonised standard EN ISO 15223-1:2021, which introduces the new ‘EU REP’ … Read more
The European Commission has published Implementing Decision (EU) 2026/1231, updating the list of harmonised standards that support compliance with the Medical Devices Regulation (EU) 2017/745 (MDR). The decision incorporates a wide range of standards covering key aspects of medical device design, manufacturing, safety, and performance, including: Publication of ISO 15223-1:2025 One of the most significant … Read more
Team-NB members adopted, a template Agreement form related to the transfer of IVDR formal application and of appropriate surveillance of legacy devices specifying the terms of the transfer in respect of legacy devices covered by Directives certificates. The full template can be accessed using the following link
The Medical Device Coordination Group (MDCG) has recently published a position paper addressing the management of Summaries of Safety and Clinical Performance (SSCPs) for medical devices and Summaries of Safety and Performance (SSPs) for in vitro diagnostic medical devices (IVDs) within EUDAMED once the system becomes mandatory. To better understand the significance of this position … Read more
From 1 July 2026, the EU will introduce a temporary €3 customs duty on imported consignments valued at up to €150, ending the long-standing duty exemption for low-value goods. The flat-rate duty will remain in place until 1 July 2028, after which standard customs duties will apply based on the type of product. The measure … Read more
As many of our clients are already aware, registration in the European Database on Medical Devices (EUDAMED) became mandatory on 28 May 2026. From this date, all economic operators wishing to place medical devices or in vitro diagnostic medical devices on the European Union market must comply with EUDAMED registration requirements in accordance with the … 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 May, please click on video below.
The European Commission has published a new Implementing Regulation introducing uniform requirements for conformity assessment activities carried out by notified bodies under the Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR). The new rules are intended to promote greater harmonisation, predictability, and efficiency within the EU medical device regulatory framework. They … Read more
MedTech Europe has published a position paper outlining its views on the proposed revision of the European Union’s Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR). According to MedTech Europe, the European regulatory framework for medical technologies has reached a critical stage. The organisation supports the European Commission’s efforts to streamline … Read more
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