MDCG guidance on "breakthrough" devices: accelerating market access

The Medical Device Coordination Group (MDCG) has published a document that provides the first comprehensive description of how to work with the category of so-called Breakthrough Devices (BtX) under the MDR/IVDR. Its main purpose is to facilitate accelerated market access for innovations that are expected to have significant clinical benefits for patients with serious, life-threatening, or irreversibly debilitating diseases, without reducing the requirements for clinical evidence. At the same time, it defines the roles of all actors and sets a framework for the distribution of clinical evidence when placing a device on the market.

Document MDCG 2025-9 establishes a common framework for Breakthrough Medical Devices (BtMD) and Breakthrough In Vitro Diagnostics (BtIVD). The definition of BtX is based on two main criteria: a high degree of novelty – in the technology, clinical procedure or application – and an expected positive clinical impact. This may consist of either a significant improvement over available alternatives and lege artis procedures or the fulfillment of a yet unmet medical need. The MDCG also emphasizes that the breakthrough status does not establish market exclusivity and does not preclude the coexistence of multiple BtX solutions in a single therapeutic area.

The approach to BtX devices based on the ongoing collection and updating of clinical data does not change the compliance requirements under the MDR/IVDR. In justified cases, it allows for the transfer of part of the confirmatory data to the post-market phase, provided that adequate assurance of the safety and performance of the device and the established PMS, including PMCF/PMPF, is maintained.

Preclinical and clinical evidence for BtX

A separate section is dedicated to the way of approaching preclinical data for BtX. Given that highly innovative solutions often lack standards and a "history" of similar products, the MDCG guidelines expect the most robust verification and validation possible, potentially even the use of in-silico modeling – but only with proven model credibility. The document acknowledges that classic randomized controlled clinical trials may not always be feasible (e.g., in the absence of suitable alternatives) and emphasizes the importance of a professionally justified study design and subsequent confirmation of the long-term safety and benefits of the device through PMS.

From a procedural point of view, the guidelines envisage a more significant role for expert panels: manufacturers shall request an opinion on BtX status, and for certain risk classes of devices, early expert advice on clinical strategy is recommended. Notified bodies should then prioritize BtX, engage in structured dialogue with manufacturers, and reassess updated clinical outputs more frequently during subsequent surveillance. Special attention is also paid to the needs of small and medium-sized enterprises in terms of reasonable fees and support for mechanisms that improve the predictability and transparency of the conformity assessment process.

Author: Markéta Hrubá