EU regs for drug-device combinations get more complicated – time for a rewrite?
This article was originally published in Clinica
Executive Summary
While the EU drug-device combination market has arguably been growing most rapidly in the last five to 10 years, it seems that it has not become any easier for companies manufacturing truly innovative products to meet the necessary regulations. In fact, as technology advances, the regulatory environment seems to have become more difficult for some, as delegates heard at the Informa Life Sciences’ 9th annual Drug/Device Combination Products meeting in Berlin last week.