The legal frameworks for medicinal products and medical devices differ fundamentally. While medicinal products are governed by Directive 2001/83/EC and Regulation 724/2004, medical devices fall under Regulation 2017/745 (MDR).
Different stakeholders — such as national competent authorities for medicinal products and Notified Bodies for medical devices — are involved in the review process and decide on the marketability of the products.
Medicinal products and medical devices can be marketed in various combinations:
As integral, inseparably connected components
Drug–device combination, or
Device–drug combination
As co-packaged but non-integral components
The development and approval of combination products present a particular challenge, as regulatory classification must be determined clearly and at an early stage. Depending on the product’s principal mode of action, either pharmaceutical law or medical device regulations will apply. A clear regulatory strategy is essential to avoid market access issues later on.
Documentation must comprehensively cover both regulatory frameworks—the requirements for medicinal product authorization as well as those for medical device regulation. Only by fully understanding and effectively integrating both systems can successful market approval and sustainable commercialization of combination products be achieved.
Diapharm supports you with comprehensive expertise and tailored solutions throughout the entire regulatory roadmap.
