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 ...
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 ...
ISO 20417:2026 Published: Key Updates to Medical Device Labelling and Information Requirements
ISO 20417:2026 has been published, setting out updated general requirements for the information to be supplied by manufacturers of medical devices and their accessories. The standard covers key elements such as device identification, labelling, packaging information, marking, and accompanying documentation, including instructions for use. ISO 20417 continues to serve as a foundational framework, establishing common ...
TEAM NB Publish Position Paper on Demonstration of Safety and Performance for Combinatorial Use of Reagent Devices with other devices or Equipment
Team-NB has published a new guidance document outlining harmonised Notified Body expectations for demonstrating the safety and performance of reagent devices intended for use in combination with other devices, equipment, or instruments. The document clarifies key considerations for ensuring compliance with Regulation (EU) 2017/746 (IVDR). It is intended to support and complement the existing Team-NB ...
Team NB Publish Position Paper on MDR/IVDR Revision
Team-NB has released a position paper addressing the European Commission’s proposed revisions to the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). The paper acknowledges that the proposed changes present opportunities to enhance predictability, transparency, and efficiency within the conformity assessment process. Notified Bodies (NBs) broadly support these objectives and recognise that the ...
Proposal for a Regulation to Simplify Rules on Medical and In Vitro Diagnostic Devices
On the 16th of December, the EU published their plans to simplify the existing EU regulatory framework for medical devices and in vitro diagnostic medical devices. This proposal seeks to streamline and future-proof the EU regulatory framework for medical devices and in vitro diagnostics. Its primary objective is to simplify applicable rules, reduce administrative burdens ...
EUDAMED to Become Mandatory as from 28th May 2026
A Commission Decision entering into force on 27 November confirmed that certain electronic systems meet their required functional specifications. This decision has triggered a six-month transition period, as outlined in the Regulation governing EUDAMED’s gradual roll-out. This would mean that the following modules will become mandatory 6 months after this publication. This would make the ...
Update to IVD Classification Guidance to Strengthen Clarity
Advena understands that the Medical Device Coordination Group (MDCG) is currently revising the guidance document MDCG 2020-16 rev.4 – Guidance on Classification Rules for In Vitro Diagnostic Medical Devices under Regulation (EU) 2017/746. This update is part of ongoing efforts to enhance clarity and improve consistency across EU medical device guidance. The current revision focuses ...
