The European regulation of drug-delivery devices

All parties concerned with the marketing of drug-delivery devices in Europe will need to comply with applicable European regulatory requirements. The European directives for medical devices address the regulation of devices intended to administer medicinal products. Also, the European Commission is developing a guidance document on the demarcation between medical devices and medicinal products. This article will discuss the European approach to the regulation of drug-delivery devices and some important regulatory issues that should be considered during the design and development phase of these products.