EMA Q&A on DDC Classification: What Question 1 Really Means

It was past eleven when he finally found the paragraph that answered his question. Three hours of reading the same EMA Q&A document, scrolling past sections on labeling and consultation procedures, circling back to the classification guidance that seemed clear on first reading but became less certain with each re-read.

The product sat in the grey zone—a wound care device with a pharmacologically active coating. Was the coating ancillary to the device, or was it the principal mode of action? The EMA's Q&A Question 1 was supposed to answer exactly this kind of question.

And it does—but not in the way most people expect on first reading. Question 1 doesn't give you a simple yes-or-no classification rule. It gives you a framework for analysis, a set of criteria to apply, and a connection to the MDR articles that define which regulatory pathway your product follows.

Understanding what Q1 actually establishes—and where it deliberately leaves room for case-by-case analysis—is the difference between a confident classification rationale and one that unravels during assessment.

What Question 1 Actually Says

Why this matters: Most regulatory professionals have read Q1 at least once. But the document's formal language obscures the practical implications. Breaking down what Q1 establishes—sentence by sentence—reveals the classification logic that EMA expects you to follow.

EMA's Q&A on implementation of MDR and IVDR (currently Revision 5, January 2025) opens its combination product guidance with the foundational classification question: how do you determine which regulatory framework applies to a product that combines drug and device elements?

The answer Q1 provides rests on a single principle: the applicable regulatory framework is determined by the principal mode of action of the combined product. This isn't a new concept—it's been the basis of EU combination product regulation since the Medical Devices Directive. But Q1 formalizes how this principle applies under MDR, connecting it specifically to Articles 1(8) and 1(9).

The applicable regulatory framework depends on the principal mode of action of the product. Where the principal intended action is not achieved by pharmacological, immunological, or metabolic means, the product is a medical device which may incorporate a medicinal substance with ancillary action. Where the principal intended action is achieved by such means, the product is a medicinal product.

The key phrase is "principal intended action." Not the most prominent component. Not the most expensive component. Not the component that appears first in the product name. The action that the product is principally intended to achieve—and the mechanism by which it achieves it.

The Classification Framework from Q1

Why this matters: Q1 doesn't just tell you what the law says—it establishes the analytical path that assessors will follow when evaluating your classification rationale. Your documentation needs to mirror this framework.

Articles 1(8) and 1(9): The Two Categories

Why this matters: These two MDR articles define the legal categories that Q1's classification framework maps onto. Understanding the distinction between them is essential for knowing which requirements apply to your product.

MDR Article 1 establishes the regulation's scope and explicitly addresses combination products. Two subparagraphs define the categories relevant to drug-device combinations:

The practical consequence of this distinction is profound. An Article 1(8) product goes through Notified Body conformity assessment as a medical device—with the NB consulting a medicinal authority about the substance. An Article 1(9) product goes through marketing authorization as a medicinal product—with the marketing authorization applicant obtaining a Notified Body Opinion on the device component per Article 117.

Same combined product concept. Completely different regulatory pathway, assessment body, documentation requirements, and timelines—all determined by which mechanism of action Q1's framework identifies as principal.

DDC Types and Their Classification

Why this matters: Abstract classification criteria become clearer through concrete product examples. Knowing how common DDC types are classified under Q1's framework helps you position your own product within the right category.

Classification Evidence Requirements

Why this matters: A classification claim without supporting evidence is an assertion, not a rationale. Q1 implicitly requires manufacturers to substantiate their classification with scientific documentation that an assessor can independently evaluate.

The depth of evidence required scales with classification certainty. A pre-filled syringe delivering an established biologic needs relatively straightforward classification justification—it's clearly drug-led. A novel wound care product with both physical and pharmacological action components requires substantially more analysis and may benefit from formal NCA classification advice before submission.

Common Misinterpretations of Q1

Why this matters: Misunderstanding Q1 leads to incorrect classification rationales that assessors will challenge—potentially invalidating your entire regulatory strategy late in the process.

Applying Q1 to Your Product

Why this matters: Knowing what Q1 says is necessary; knowing how to apply it to your specific product is what prevents classification challenges during assessment.