MDCG Guidance on Breakthrough Devices under the MDR and the IVDR

The Medical Device Coordination Group (MDCG) has published its Guidance, MDCG 2025-9, on Breakthrough Devices within the Medical Devices Regulation (MDR) and the in vitro diagnostics Medical Devices Regulation (IVDR).

Neither the MDR nor the IVDR include a definition of what constitutes a Breakthrough Device. MDCG 2026-9, however, provides that a medical device or an IVD will be considered a Breakthough Device if it fulfils defined criteria:

• The device introduces a high degree of novelty with respect to the device technology, the related clinical procedure, and/or the application of the device in clinical practice; and

• The device is expected to provide a significant positive clinical impact on patients or public health, for a life-threatening or irreversibly debilitating disease or condition, by either:

  • Offering a significant positive clinical impact on patients or public health compared to available alternatives and the state of the art; or

  • Fulfilling an unmet medical need where there is an absence or insufficiency of available alternative options for that purpose.

The Guidance provides direction concerning the steps to be taken by manufacturers to demonstrate that their medical device or IVD fulfils the criteria permitting them to be considered Breakthrough Devices and to ensure that clinical, non-clinical, and post-market surveillance (PMS) and PMCF/PMPF obligations are fulfilled.

Acknowledging that, due to limited prior scientific knowledge or data from similar devices (if any), devices with a high degree of novelty may be associated with uncertainty regarding the device’s expected safety or performance the Guidance provides that a balanced approach is needed to ensure that the level of uncertainty associated with Breakthrough Devices does not unnecessarily prevent timely patient access to devices that provide significant positive clinical impact compared with the state of the art and alternatives (if any).

In particular, in cases where the medical device or IVD is intended to fulfil unmet medical need it may be acceptable for a Breakthrough Device to be placed on the market with a higher level of uncertainty and more limited pre-market clinical evidence provided that a well-defined plan is in place to collect confirmatory data through comprehensive PMS and PMCF/PMP.

‍The Guidance includes specific discussion of Breakthough Devices that contain high-risk AI systems and how related risks should be addressed.

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