# Understanding MDCG Guidance: Distinguishing Medical Devices from Medicinal Products and Key Concepts Explained
The European Union (EU) has one of the most comprehensive regulatory frameworks for medical devices and medicinal products in the world. However, the distinction between these two categories can sometimes be challenging, especially for innovative products that blur the lines between traditional definitions. To address this, the Medical Device Coordination Group (MDCG) has issued guidance to help manufacturers, regulators, and stakeholders navigate these complexities. This article explores the key concepts outlined in MDCG guidance, focusing on how to distinguish medical devices from medicinal products and the implications for compliance.
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## **What is the MDCG?**
The Medical Device Coordination Group (MDCG) is a body established under the EU Medical Device Regulation (MDR, Regulation (EU) 2017/745) and In Vitro Diagnostic Medical Device Regulation (IVDR, Regulation (EU) 2017/746). Composed of representatives from EU Member States, the MDCG provides expert advice to the European Commission and supports the consistent implementation of the MDR and IVDR across the EU.
One of the MDCG’s key roles is to issue guidance documents that clarify regulatory requirements, address ambiguities, and ensure harmonized interpretation of the regulations. These documents are not legally binding but are highly influential and widely followed by manufacturers, notified bodies, and competent authorities.
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## **Medical Devices vs. Medicinal Products: The Regulatory Challenge**
The distinction between medical devices and medicinal products is critical because each category is governed by different regulations:
– **Medical Devices** are regulated under the MDR and IVDR.
– **Medicinal Products** are regulated under Directive 2001/83/EC and Regulation (EC) No 726/2004.
While the two categories have distinct definitions, the rapid pace of innovation in healthcare has led to the development of products that combine characteristics of both. For example, drug-device combination products, advanced therapy medicinal products (ATMPs), and borderline products often raise questions about their primary mode of action and regulatory classification.
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## **Key Definitions**
To understand the distinction, it is essential to grasp the definitions provided in EU legislation:
1. **Medical Device (MDR Article 2(1)):**
A medical device is any instrument, apparatus, appliance, software, implant, reagent, material, or other article intended by the manufacturer to be used for specific medical purposes, such as diagnosis, prevention, monitoring, treatment, or alleviation of disease. The primary mode of action of a medical device is typically physical, mechanical, or chemical (excluding pharmacological, immunological, or metabolic means).
2. **Medicinal Product (Directive 2001/83/EC, Article 1(2)):**
A medicinal product is any substance or combination of substances presented as having properties for treating or preventing disease in humans, or that may be used in or administered to humans to restore, correct, or modify physiological