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 ...
EUDAMED Becomes Mandatory
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 ...
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.
New EU Implementing Regulation Establishes Uniform Requirements for Conformity Assessment and Notified Bodies
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 ...
MedTech Europe Publishes Position Paper on MDR and IVDR Revision
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 ...
UPDATE: Study Supporting the Monitoring of the Availability of Medical Devices on the EU market
The EU Commission has updated the results of the Study Supporting the Monitoring of the Availability of Medical Devices on the EU market. This new update is concerning a period ending in December 2025. The results have been documented in a .pdf power point which is split up into 5 sections: To offer some background ...
Key MDR/IVDR Compliance Deadlines: May 2026
As the EU regulatory framework for medical devices and in vitro diagnostic devices continues to mature, May 2026 marks a critical milestone for manufacturers operating under the Medical Device Regulation (EU) 2017/745 and the In Vitro Diagnostic Regulation (EU) 2017/746. Several high-priority deadlines will take effect during this month, requiring immediate attention to ensure ongoing ...
Video News Summary – April
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 April, please click on video below.
