Combination Products
Where Pharma
Meets Medtech
Combination products are where life science becomes most complex.
Two regulatory systems. One product.
Medicines and medical devices brought together in a single therapeutic solution and twice the regulatory challenge.
This is where many companies struggle. And this is where our expertise makes the biggest impact.
Combination Products
What is a Combination Product?
Combination products are therapeutic solutions that include both a medical device and a pharmaceutical component.
Common examples include:
- Prefilled syringes – where the drug and delivery system form a single unit
- Inhalers – where the device is essential to the drug’s function
- Drug-eluting stents – vascular stents that release a drug over time
- Transdermal patches – delivering an active substance through the skin
- Antimicrobial-coated implants – where the device includes a medicinal substance
These products offer significant value to patients, but also come with high regulatory complexity.
Combination Products
Combination Products
Why Are Combination Products More Complex?
Unlike “pure” pharmaceuticals or medical devices, combination products cross two separate regulatory frameworks. This creates challenges at several levels:
Classification
Is the product primarily a medicine or a device? The primary mode of action (PMOA) determines which legal pathway applies – MDR/IVDR or pharma legislation (EU), or device vs. drug pathway (US).
Dual Requirements
Each component must meet its respective requirements:
- The drug must comply with quality, stability, GMP and impurity testing
- The device must demonstrate safety, performance and proper documentation
Multiple Regulators
In the EU, both EMA (medicines) and Notified Bodies (devices) may be involved.
In the US, the FDA Office of Combination Products coordinates review, but both CDRH (devices) and CDER (drugs) may participate.
Development and Lifecycle Challenges
- Clinical trials must prove both drug efficacy and device usability
- Manufacturing often requires two GMP systems
- Post-market activities like vigilance and change control are more demanding, as issues may relate to the drug, the device or the interaction between them
Combination Products
Combination Products
Why Strategy Matters from the Start
Without a clear regulatory strategy, combination products can run into real trouble. Costly delays. Redundant work. Conflicting agency feedback. And in the worst cases, a misclassification that derails your entire development plan.
We’ve seen it happen.
But with the right strategy from the start, it doesn’t have to. We know the pitfalls. And more importantly, how to avoid them.
Combination Products
Why RegSmart can help you
We do nothing regular within regulatory
At RegSmart, we bring together deep experience in both pharma and medtech.
Our senior team understands both systems, and how to bridge them.
We help you:
- Define the right regulatory pathway from the start
- Anticipate classification, clinical, and manufacturing pitfalls
- Navigate complex interactions with EMA, FDA and Notified Bodie
Combination Products
Combination Products
Need Clarity for Your Combination Product?
Let us help you design a regulatory strategy that’s truly fit for purpose, tailored to your product, aligned with your goals and built to withstand scrutiny.
From early development to submission and beyond, we guide you every step of the way so you can move forward with clarity, speed and confidence.
Combination Products
