ISO 10993-3:2026 Published: Updated Requirements for Biological Evaluation of Medical Devices
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 ...
MDCG 2026-5 MDCG Position Paper: UDI Assignment Between Manufacturers and Distributors
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 ...
MDCG 2021-5 Rev. 1 Guidance on standardisation for medical devices Appendix: Transition to the ‘EU REP’ symbol in EN ISO 15223-1 June 2026
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’ ...
TEAM NB Release Template for the Agreement Related to the Transfer of IVDR Formal Application and of Appropriate Surveillance of Legacy Devices
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
MDCG 2026-4 MDCG Position Paper: Management of SS(C)P in EUDAMED after mandatory use
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 ...
Video News Summary – May
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.
UPDATE: MDCG 2021-24 Rev.1 Guidance on classification of medical devices
Medical device classification in the EU follows a risk-based approach, considering factors such as invasiveness, duration of contact, and potential impact on the body. These criteria, set out in Annex VIII of the MDR, guide manufacturers in assigning the correct class, which in turn determines the level of regulatory scrutiny and conformity assessment required. The ...
UPDATE: Manual on borderline and classification for medical devices under Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices
The Borderline Manual on Medical Devices has recently been updated, introducing five additional product examples that fall into “grey areas” of qualification and classification. Originally published in 2022, this guidance aims to support manufacturers in determining whether a product qualifies as a medical device and how it should be classified under the MDR. 1. Device ...
UPDATE: Q&A on the Information Obligation in Case of Interruption or Discontinuation of Supply of Certain Medical Devices and In Vitro Diagnostic Devices.
The European Commission has updated its Q&A on the information obligations related to the interruption or discontinuation of supply of certain medical devices and in vitro diagnostic devices (IVDs). By way of background, Regulation (EU) 2024/1860—adopted in 2024—introduced several amendments aimed at strengthening patient safety and improving regulatory efficiency. Key developments include the gradual roll-out ...
COMMISSION IMPLEMENTING DECISION (EU) 2026/760
The European Commission has published Implementing Decision (EU) 2026/760, further updating the list of harmonized standards supporting compliance with the Medical Devices Regulation (EU) 2017/745 (MDR). In particular, the Decision adds three new harmonized standards: Implementing Decision (EU) 2026/760 can be accessed using the following link
