Distinguishing a medical device from a cosmetic, biocide, or drug is a challenging task when a product seems to fit the definitions for two or more product types. These products are often referred to as borderline or combination products. To successfully bring a combination product to the market, you need expertise in requirements for drugs, devices, and more to determine how these rules apply to your product.
Identifying the appropriate regulations for a device is important: it can affect the device’s profitability, how quickly you can bring the device to market, or which market to enter first. Our team has deep expertise classifying combination and borderline products in the US, Europe, and markets around the world. We understand how regulations intersect to determine the regulatory requirements for your combination product.