Medical Device Coordination Group (MDCG) updates – Oct to Dec 2025

DateGuidance NoAbout the guidance
19 Dec 2025MDCG 2025–10 Guidance on post-market surveillance of medical devices and in vitro diagnostic medical devices (December 2025)

Unless otherwise stated, this guidance is applicable to all medical devices (MDs) and in vitro
diagnostic medical devices (IVDs). The main objectives of this guidance are:
1. To describe the PMS system.
2. To describe the PMS plan.
3. To describe the main activities within the PMS system.
4. To clarify the interactions of the PMS system in accordance with Article MDR/Article IVDR with other key aspects of the QMS as described in Article 10(9) MDR and Article 10(8) IVDR)
Dec 2025MDCG 2025-9Guidance on Breakthrough Devices (BtX) under Regulations 2017/745 & 2017/746

In certain circumstances, a medical device (MD) or in vitro diagnostic medical device (IVD) may be described as a breakthrough device (BtX) when it represents an innovation that is expected, based on available information, to offer a novel diagnostic or therapeutic option addressing an unmet medical need for a particular patient population with serious and life threatening diseases or conditions when compared with state of the art.

This guidance has been developed so that a MD or IVD can be designated as a BtMD or BtIVD at an early stage of its development, months to years before it is expected to achieve market access.

BtX designations may be granted to multiple MDs or IVDs in development that have the same proposed intended purpose(s) or indication(s), and a BtX’s breakthrough status is not influenced by the placement on the market of another MD or IVD with the same intended purpose.

Once designated, a BtX can avail of certain supports and benefits to aid in its development and timely market access, as described later. A device’s breakthrough status may remain valid for as long as needed for the purposes of applying this guidance.
Dec 2025MDCG 2025-7 Rev 1MDCG Position Paper: Timelines of the implementation of ‘Master UDI-DI’ to contact lenses and spectacle frames, spectacle lenses and ready-to-wear reading spectacles

This MDCG Position Paper aims at clarifying the timelines of the implementation of the Master UDI-DI to the abovementioned devices, as established in the respective Delegated Regulations, and the obligation to label the Master UDI-DI and to use the UDI/Device
registration module of Eudamed, and the interrelation between them.

The revisions are detailed on page 2 of the position paper..