NSAI To Withdraw from Medical Device Certifications
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 ...
New Consolidated Version of MDR Published
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
EU Commission Publish Videos from the Third EMDN Training
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 ...
Meet Advena at MDR/IVDR Summit 2026
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 ...
Delegated acts on well-established technologies published
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 ...
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 ...
Updated List of Notified Bodies’ Standard Fees
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 ...
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’ ...
Commission Implementing Decision (EU) 2026/1231
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 ...
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 ...
