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 for patients with serious or life-threatening conditions and addresses an unmet medical need compared with the current state of the art.
Aligned with the MDR and IVDR, this guidance outlines a streamlined and proportionate regulatory pathway to support timely CE marking and patient access to breakthrough devices, while maintaining robust clinical and performance evidence requirements. It promotes an appropriate balance between pre-market and post-market evidence generation, ensuring patient safety, clinical benefit, and innovation.
Breakthrough designation can be granted early in development and may apply to multiple devices with the same intended purpose. It does not confer market exclusivity and remains valid as long as needed. Designated devices benefit from regulatory support to reduce unnecessary delays and facilitate development and market access.
This guidance outlines the regulatory process for qualifying, assessing, and certifying breakthrough medical devices and IVDs, defining the roles of manufacturers, notified bodies, expert panels, EMA, and national authorities. It addresses available regulatory supports, clinical and performance evaluation requirements, use of non-clinical and preclinical data, and post-market follow-up.
The guidance applies to all device technologies and risk classes, excluding custom-made devices, in-house devices, and MDR Annex XVI products without a medical purpose.
The guidance document can be accessed using the following link
