Almost 300 million people worldwide are affected by the 6,500 to 10,000 rare diseases known today. Yet, nearly 90% of these diseases have no approved treatment.

At the same time, medical breakthroughs such as AI-enabled diagnostics, novel implants, and other innovative devices are waiting to reach the market.
In MDR-regulated markets, however, the barriers to market entry are high, as the regulatory framework was primarily designed for more conventional applications.

While the goal of protecting patients through robust clinical evidence is absolutely the right one, this approach can fall short in these unique scenarios.

Small patient populations and the absence of historical data make it difficult to generate the level of clinical evidence expected, making market access slow, costly, and in some cases prohibitively expensive.
Yet these devices may represent the only therapeutic option for a small patient population or offer the potential to fundamentally improve the diagnosis or treatment of serious diseases.

Recognizing this, the proposed MDR revision introduces dedicated pathways for orphan and breakthrough devices.

In this webinar, we'll examine the current status of these proposals, discuss what they are intended to achieve, and explore what they could mean for manufacturers, regulators, and ultimately, patients.