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 ...
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 ...
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.
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: 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 ...
UPDATE: MDCG 2025-7 Rev. 1 MDCG Position Paper: Timelines of the implementation of ‘Master UDI-DI’ to contact lenses and spectacle frames, spectacle lenses and ready-to-wear reading spectacles
The MDCG has recently updated a guidance document concerning the timelines of the implementation of ‘Master UDI-DI’ to contact lenses and spectacle frames, spectacle lenses and ready-to-wear reading spectacles. To offer some background to this document, the Unique Device Identification (UDI) system under Article 27 MDR ensures the traceability of medical devices by requiring manufacturers ...
MDCG 2025–10: Guidance on post-market surveillance of medical devices and in vitro diagnostic medical devices
The MDCG has recently published a guidance concerning post-market surveillance requirements for Medical Device and IVD’s. Unless otherwise specified, this guidance applies to all medical devices (MDs) and in vitro diagnostic medical devices (IVDs). To offer some background to this guidance document, Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in ...
MDCG 2025-9: Guidance on Breakthrough Devices (BtX) under Regulations 2017/745 & 2017/746
The MDCG has recently published a guidance document concerning BtX, commonly known as break through devices. To offer some background to this guidance document, a medical device (MD) or in vitro diagnostic (IVD) may be designated as a breakthrough device (BtX) if it represents a significant innovation that offers a novel diagnostic or therapeutic solution ...
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 ...
MDCG Releases Draft Guidance on Trend Reporting
The MDCG has released a draft guidance document with regard to Trend Reporting, currently numbered as MDCG 2025-XX. To provide context for this release, the draft guidance document MDCG 2025-XX has been developed to explain and clarify key aspects of Trend reporting as outlined in Article 88 of Regulation (EU) 2017/745 on medical devices (MDR) ...
