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: MDCG 2021-24 Rev.1 Guidance on classification of medical devices
Medical device classification in the EU follows a risk-based approach, considering factors such as invasiveness, duration of contact, and potential impact on the body. These criteria, set out in Annex VIII of the MDR, guide manufacturers in assigning the correct class, which in turn determines the level of regulatory scrutiny and conformity assessment required. The ...
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 ...
COMMISSION IMPLEMENTING DECISION (EU) 2026/760
The European Commission has published Implementing Decision (EU) 2026/760, further updating the list of harmonized standards supporting compliance with the Medical Devices Regulation (EU) 2017/745 (MDR). In particular, the Decision adds three new harmonized standards: Implementing Decision (EU) 2026/760 can be accessed using the following link
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 ...
New Delegated Acts under the MDR Introduce Targeted Relief for Well-Established Technologies
Two new delegated acts under the EU Medical Device Regulation (MDR)—C (2026) 1798 and C (2026) 1809—have been adopted, introducing important updates for manufacturers of certain categories of medical devices. Both acts focus on well-established technologies (WET): devices that are widely recognised as safe and effective due to their simple, stable design, long-standing clinical use, ...
UPDATE: Notified Bodies Survey on Certifications and Applications
The EU Commission has updated the current state of MDR/IVDR applications with the notified bodies. This new update is concerning a period ending in October 2025. The results have been documented in a .pdf power point which is split up into 4 sections: MDR Statistics The MDR survey results concerning a period ending on October ...
UPDATE: MDCG 2025-8 Rev. 1 Guidance on the implementation of the Master UDI-DI solution for spectacle frames, spectacle lenses and ready-to-wear reading spectacles
The EU Medical Device Regulation (MDR) introduced the Unique Device Identification (UDI) system to improve the identification and traceability of medical devices. Manufacturers must assign UDI codes (Basic UDI-DI, UDI-DI, and UDI-PI) to most devices before placing them on the market and register key identifiers in the EUDAMED database. For highly individualised devices, such as ...
