Drug/device combination products are an unusual product from a regulatory point of view, as they comprise products that originate in the pharmaceutical, biopharmaceutical, biotechnology, and medical device sectors,  which differ conventionally. Because of this, combination products do not fit into a single regulatory framework and they are thus more complex than average products in terms of determining the regulatory requirements that they must comply with.

Companies manufacturing drug/device combination products should have a clear understanding of the regulations that are applicable to them. Take one of our ensure to increase that understanding!