Development within the European Union of medical devices incorporating ancillary medicinal substances

In recent years, there has been a remarkable increase in the development and clinical use of Medical Devices (MDs). To date, about 500,000 different types of MDs are commercialised in the EU, with a global turnover of about 100 billion Euros. Increasingly frequently, manufacturers develop devices containing medicinal substances; i.e., a substance that used alone can be considered a Medicinal Product (MP) that help or integrate the main action of the MD (ancillary action). The correct regulatory classification of these MDs is often difficult and is a matter of discussion with the Competent Authorities (CAs). However, a correct classification is crucial for the development strategy and for the subsequent pre-clinical and clinical studies. In fact, the pre-clinical and clinical development plan, the size and number of studies, the reference guidelines and the competent authorities are different for MDs and Medicinal Products (MPs). In the present paper, we analyse and discuss the key phases of development of a MD incorporating an ancillary medicinal substance. Special attention is devoted to: i) the classification of the products according to the relevant European Guidelines; ii) the methodology for clinical evaluation; iii) the assessment procedure by the CA. Finally, we mention a possible approach to address the complexity of the procedure, through the implementation of development teams.