UPDATE: MDCG 2020-16 rev.5: Guidance on Classification Rules for In Vitro Diagnostic Medical Devices under Regulation (EU) 2017/746
The Medical Device Coordination Group (MDCG) has updated its guidance on the classification of in vitro diagnostic medical devices (IVDs) under Regulation (EU) 2017/746 (IVDR). The guidance provides clarification on the application of the classification rules set out in Annex VIII of the IVDR and is intended to support the consistent classification of IVDs across ...
26th September 2026 Deadline for Class C IVD Manufacturers
For manufacturers of Class C In Vitro Diagnostic (IVD) medical devices, September 26, 2026, is a critical regulatory milestone. Under the EU In Vitro Diagnostic Regulation (IVDR), manufacturers of legacy Class C devices must have a signed written agreement in place with an EU Notified Body by this exact date to maintain European market access.
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 ...
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’ ...
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.
