
MDCG Guidance on Borderline Between Medical Devices and Medicinal Products: Combinations
The final article of the cycle is dedicated to combination products and their specific regulatory nature.
The final article of the cycle is dedicated to combination products and their specific regulatory nature.
The new article further describes the applicable regulatory considerations, paying additional attention to the key concepts used in the context of borderline products in order to ensure the relevant regulations are applied properly.
The article highlights the key points related to the regulatory requirements for combination studies intended to be carried out in Switzerland.