Medicinal Product vs Medical Device: The Borderline Determination Guide

She overheard the conversation at a regulatory conference coffee break. Two directors from competing companies, discussing the same product category.

One had filed under pharmaceutical legislation. The other was pursuing CE marking.
Same mechanism of action. Same intended use. Different regulatory conclusions.

Both companies had defensible positions. Both had documented their reasoning. Neither was definitively wrong—but they would face very different regulatory pathways, timelines, and approval bodies.

The borderline between medicinal products and medical devices isn't a bright line. It's a determination based on principal intended action—and for products near the boundary, that determination requires careful analysis and often formal authority guidance.

The Fundamental Definitions

Why this matters: These definitions have legal force and are the starting point for any classification analysis. Understanding the exact regulatory language prevents misinterpretation.

Medicinal Product Definition

Directive 2001/83/EC Article 1(2) defines a medicinal product as:

"(a) Any substance or combination of substances presented as having properties for treating or preventing disease in human beings; or

(b) Any substance or combination of substances which may be used in or administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis."

Medical Device Definition

MDR 2017/745 Article 2(1) defines a medical device as:

"Any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes:

— diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease,
— diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability,
— investigation, replacement or modification of the anatomy or of a physiological or pathological process or state..."

The critical distinction in the device definition: the product "does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means."

The Key Criterion: Principal Intended Action

Why this matters: This single criterion drives the entire classification. If you can definitively establish the principal intended action, you've answered the fundamental regulatory question.

Let's define each mode of action:

Borderline Product Assessment Process

Why this matters: Borderline products are those where classification isn't immediately clear. Having a structured assessment approach—and knowing when to seek authority guidance—prevents costly classification errors.

The qualification and classification of borderline products is the responsibility of national competent authorities for medicinal products and/or medical devices. This isn't a decision manufacturers make unilaterally—though they must justify their position.

Key guidance documents for borderline assessment:

• MDCG 2022-5: Guidance on borderline between medical devices and medicinal products under MDR
• MDCG Manual on borderline and classification: Explanations and worked examples
• EMA Q&A on MDR/IVDR implementation: Addresses combination products specifically

EMA and Competent Authority Advice Procedures

Why this matters: Knowing where to get authoritative guidance—and the difference between informal input and formal decisions—helps you navigate borderline classifications efficiently.

Informal Input: EMA Innovative Task Force (ITF)

EMA's Innovative Task Force provides early, informal scientific input for innovative drug-device combinations and borderline products. Key characteristics:

Formal Advice: National Competent Authorities

For formal classification decisions, contact a national competent authority. The recommendation is to seek this advice before submitting an application—not during assessment when timeline pressure is highest.

European Commission Decisions

The European Commission can issue decisions, at the request of a Member State, on whether a product or product group falls within the definition of a medical device. These decisions provide legal certainty across all Member States but are relatively rare and reserved for products of broader significance.

Borderline Product Examples

Why this matters: Abstract criteria become clearer through concrete examples. These products illustrate how the principal intended action test applies—and where borderline cases arise.

When Classification Is Disputed

Why this matters: Disputes happen. Knowing the resolution mechanisms—and how to avoid disputes in the first place—protects your regulatory timeline.

The regulations are clear: the procedures of the medical device directives and the medicinal products directive do not apply cumulatively. One framework governs—based on principal mode of action. But what happens when stakeholders disagree?

Manufacturer vs Notified Body Disputes

If a manufacturer and Notified Body disagree on device classification, the dispute is referred to the national competent authority for medical devices in the Member State where the manufacturer is registered. The NCA decision is binding for that conformity assessment.

Cross-Border Considerations

Different Member States may reach different conclusions on borderline products. While MDCG guidance promotes harmonization, NCA decisions remain national. If market access across multiple Member States is planned, consider:

• Seeking guidance from multiple NCAs early
• Using established classifications of similar products as precedent
• Requesting European Commission decision for products of broader significance

A Practical Determination Framework