Medicinal products meet medical devices: Classification and nomenclature issues arising from their combined use

When a medicinal product (MP) and a medical device (MD) are combined, their correct classification implies discrimination among different possible scenarios, based on the nature of the combination and the principal mechanism of action. In the European Union (EU), stakeholders deal with a lack of harmonization, which can represent an obstacle toward the development of these products, and a complex nomenclature, emerging from two divergent regulatory philosophies (i.e., that of MPs and that of MDs). In the USA, where the US Food and Drug Administration (FDA) supervises MDs, drugs, and biological products, stakeholders interact with a single authority, where any issue is addressed internally.

Automated summary

The correct classification of combined medicinal products and medical devices is crucial for their development. Stakeholders in the European Union face obstacles due to lack of harmonization and divergent regulatory philosophies. In contrast, in the United States, stakeholders interact with a single authority, leading to more efficient issue resolution.