--- title: "Combination Products | QbD Group" description: "Navigating EU and US regulatory pathways for combination products Navigating regulatory pathways can often feel like a maze, leading to uncertainty and…" url: https://qbdgroup.com/en/industries/combination-products type: "Page" language: en publisher: "QbD Group" citation: "QbD Group, \"Combination Products | QbD Group\", https://qbdgroup.com/en/industries/combination-products" --- Pharma & Biotech # Combination Products Navigating EU and US regulatory pathways for combination products Navigating regulatory pathways can often feel like a maze, leading to uncertainty and potential pitfalls in the submission process. This is even more so when it comes to combination products. Nothing is more disheartening than investing significant time and resources into developing your combination product, only to face rejection from regulatory authorities due to unclear expectations or insufficient data. At QbD Group, we offer **comprehensive solutions to navigate the complex process of registering these innovative products** in both the European Union (EU) and the United States (US). Our approach ## Regulatory framework In Europe, combination products are regulated based on their **Primary Mode of Action (PMOA)** — whether the product acts primarily as a medicinal product or a medical device. This determines which regulatory pathway applies. Key challenges we address #### Dual regulatory frameworks Combination products must satisfy both pharmaceutical and device regulatory requirements — under MDR in Europe and FDA oversight in the US — often with different authorities and procedures. #### Primary Mode of Action uncertainty Determining whether your product is device-led or drug-led defines the entire regulatory pathway, and misclassification can result in costly delays or rejection. #### Cross-functional coordination Aligning drug, device, and packaging teams across different quality systems, testing requirements, and development timelines. #### Complex submission requirements Integrated regulatory dossiers must satisfy multiple authorities — from Notified Bodies and EMA opinions in the EU to FDA center designations and marketing applications in the US. 1 ### Device-led Combination Products If your product is classified as a medical device with an ancillary medicinal substance, it must comply with **EU MDR 2017/745**. The Notified Body must consult the EMA for a scientific opinion on the excipient if it is derived from human blood or plasma, has been previously assessed by the EMA, or falls under the centralized procedure. In other cases, the Notified Body may consult either the National Competent Authority or the EMA. Examples → Drug-eluting stent → Device pathway (MDR + EMA opinion) → Coated catheter → Device pathway (MDR) 2 ### Medicinal Product-led Combination Products If your product is primarily a medicinal product, the combination is regulated under the **Medicinal Product Directive (2001/83/EC)**. The type of product — and how the medical device is integrated — influences the required documentation and regulatory steps. Integrated — device is part of the product Co-packaged — medicinal product and device are packaged together Referenced — product refers to a separate device used during administration Examples → Prefilled syringe → Drug pathway (MPD) → Contraceptive patch → Drug pathway (MPD) How it works ## Our structured approach ### Identify the lead FDA center Determine the Primary Mode of Action (drug, device, or biologic). If unclear, submit a Request for Designation (RFD) to the FDA. ### Determine the investigational application Depending on the PMOA, apply for an IND (Investigational New Drug Application) when the primary mode is drug or biologic, or an IDE (Investigational Device Exemption) when the primary mode is device. Consider the combination product as a whole. ### Select the marketing application Drug-led: NDA or ANDA. Biologic-led: BLA. Device-led: PMA, De Novo, or 510(k). The marketing application depends on the constituent part with the PMOA. ### Post-market lifecycle management Maintain ongoing compliance across both regulatory frameworks, including vigilance, PMS, and lifecycle management for your combination product. What we deliver ## Our integrated offerings Our integrated offerings support organizations across their full operational lifecycle, from compliance activities to sustained control, improvement, and digital enablement. PMOA classification and pathway determination MDR 2017/745 compliance for device-led combinations EMA scientific opinion coordination Notified Body and National Competent Authority consultation Medicinal Product Directive compliance for drug-led combinations Key benefits ## What you gain ### Tailored regulatory strategy We help you develop a custom regulatory roadmap to ensure your product meets all compliance and market entry requirements. ### Expert guidance on procedures Our team guides you in selecting the most suitable regulatory procedure for your product, saving time and minimizing hurdles. ### End-to-end lifecycle management From concept to market launch, we offer holistic support for every stage of your combination product's journey. ### In-depth regulatory knowledge Leverage our extensive expertise to navigate stringent requirements confidently and accelerate your product's market readiness. Why QbD Group ## Your trusted partner Cross-industry expertise our regulatory specialists cover Pharma, Biotech, Medical Devices, IVD, and Combination Products under one roof. Strategic regulatory planning we align your regulatory pathway with commercial objectives to accelerate time-to-market. Proven track record with thousands of successful submissions and dossier management projects across Europe, we deliver results you can count on. Scalable support from a single regulatory question to full outsourced regulatory operations, we adapt to your needs. Cross-industry expertise Strategic planning Proven track record Scalable support FAQ ## Frequently asked questions ### ### ## Have questions about the regulatory pathways for your combination product? We understand the complexities of navigating EU and US regulations. Whether you're seeking clarity on the Primary Mode of Action (PMOA), determining the right regulatory pathway, or managing lifecycle requirements, our experts are here to help. Contact us --- Source: https://qbdgroup.com/en/industries/combination-products — © QbD Group. Quote freely with attribution and a link back.