Drug-Device Combination Products
Integrated Regulatory Solutions for Complex Combination Products
Drug-device combination products require careful regulatory assessment because different legal, technical, and quality requirements may apply simultaneously.
Avary Consulting supports companies in determining the regulatory status of combination products, developing appropriate approval strategies, and coordinating technical, pharmaceutical, and quality-related activities.
In Europe, we consider the relevant provisions of Article 1 of Regulation (EU) 2017/745 (MDR), applicable pharmaceutical legislation, and the EMA guideline addressing the quality requirements for drug-device combinations.
For the United States, we consider FDA requirements for the regulatory classification of combination products under 21 CFR Part 3 and applicable current good manufacturing practice requirements under 21 CFR Part 4.
Our services include regulatory classification, approval strategy development, interface management, technical evidence planning, risk management, and regulatory authority communication.
Our Recommendation: For combination products, regulatory responsibilities and the requirements applicable to individual product components should be clarified during the early stages of development.