Combination Products – Regulatory Classification and Applicable Frameworks
A combination product contains both a medicinal substance and a medical device component. Its regulatory classification is determined by the product’s intended use and principal mode of action. In general, a combination product is regulated either as a medicinal product or as a medical device. However, even when one regulatory framework applies as the primary pathway, relevant requirements from other frameworks may also apply, depending on the specific characteristics and components integrated into the product.
LINK Medical supports clients developing drug–device combination products from
- early regulatory strategy and product classification
- development,
- preparation of marketing authorization or CE-marking
documentation including registration, and post-market compliance.
Our multidisciplinary experts bring integrated expertise across medicinal products, medical devices, regulatory affairs, CMC, clinical development, and pharmacovigilance, translating regulatory complexity into practical, efficient, and fully compliant solutions.
For more information:
Combined studies | Swedish Medical Products Agency
Combination Products Operational Group | European Medicines Agency (EMA)
800 +
clinical trials
170 +
employees
20 +
therapeutic areas
30 +
years of experience