# Overview of MDCG Guidance on Differentiating Between Medical Devices and Medicinal Products
The European regulatory landscape for healthcare products is complex, with distinct frameworks governing medical devices and medicinal products. To ensure patient safety and compliance with European Union (EU) regulations, it is critical to correctly classify a product as either a medical device or a medicinal product. Misclassification can lead to regulatory non-compliance, delays in market access, and potential legal consequences. To address this challenge, the Medical Device Coordination Group (MDCG) has issued guidance to help stakeholders navigate the classification process. This article provides an overview of the MDCG guidance on differentiating between medical devices and medicinal products.
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## Understanding the Regulatory Framework
The EU regulates medical devices under the Medical Device Regulation (MDR, Regulation (EU) 2017/745) and medicinal products under the Medicinal Products Directive (Directive 2001/83/EC). While both frameworks aim to ensure the safety and efficacy of healthcare products, they have distinct definitions, requirements, and approval processes.
– **Medical Devices**: Defined under the MDR as instruments, apparatus, appliances, software, implants, reagents, or other articles intended by the manufacturer to be used for medical purposes, such as diagnosis, prevention, monitoring, treatment, or alleviation of disease or injury. Medical devices achieve their primary intended action through physical, mechanical, or other non-pharmacological means.
– **Medicinal Products**: Defined under Directive 2001/83/EC as substances or combinations of substances intended to treat or prevent disease in humans, or to restore, correct, or modify physiological functions through pharmacological, immunological, or metabolic action.
The key distinction lies in the **primary mode of action** (PMOA) of the product. Medical devices rely on physical or mechanical means, while medicinal products exert their effects through pharmacological, immunological, or metabolic mechanisms.
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## The Role of MDCG Guidance
The MDCG, established under the MDR, provides expert advice and guidance to ensure the uniform application of EU regulations. Its guidance documents are not legally binding but are highly influential in interpreting and implementing regulatory requirements.
The MDCG guidance on differentiating between medical devices and medicinal products aims to clarify the classification process, particularly for borderline products that may fall into either category. These products often combine characteristics of both medical devices and medicinal products, making classification challenging.
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## Key Considerations in Differentiating Between Medical Devices and Medicinal Products
The MDCG guidance outlines several key factors to consider when determining whether a product is a medical device or a medicinal product:
### 1. **Primary Mode of Action (PMOA)**
– The PMOA is the decisive factor in classification. If the product achieves its primary intended purpose through pharmacological, immunological, or metabolic action, it is classified as a medicinal product. If the primary action is physical or mechanical, it is classified as a medical device.
– For combination products