DDC products are a strategic inflection point in EU development. For biologics, vaccines, ATMPs, inhaled medicines and self-administered therapies, the device is not a delivery tool only as it can influence dose, usability, adherence, clinical performance and benefit-risk.
EU DDCs sit at the interface of medicinal product legislation and MDR 2017/745. For integral DDCs where medicinal action is principal, the product remains regulated as a medicinal product, however, the device part must show conformity with applicable MDR Annex I GSPRs. Under MDR Article 117, the marketing authorization application (MAA) must include conformity evidence, an EU declaration/certificate or, where required, a Notified Body Opinion.
Scientifically, the device cannot be late-stage packaging. It affects compatibility, stability, sterility, extractables/leachables, biocompatibility, human factors, use-error risk and lifecycle strategy.
Strong EU DDC programs integrate pharmaceutical, device, quality, nonclinical, clinical, human factors, regulatory and supply-chain planning from the start. The dossier must tell one coherent story: how the product is designed, tested, manufactured, used and controlled to deliver appropriate efficacy, safely and reliably.
Developing a DDC product? Contact Starodub to align your strategy with EU expectations.
