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
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.
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 ...
