Combination Products

Navigating Clinical Evaluation Process for Combination Products! Combination products are a niche class of medical devices whereby two or more regulated constituents, such as drugs and devices are combined to achieve a specific therapeutic purpose. These products necessarily require careful consideration of pharmaceutical and medical device regulations that ensure compliance and demonstrate both safety, performance as well as clinical benefit. This article details the step-by-step approach and considerations that guide the Clinical Evaluation Process in the context of combination products that fall under the EU’s Medical Device Regulation 2017/745. What Are Combination Devices? Combination devices are products that either: 1. [...]