Medical Device Regulation (MDR) for Combination Products: A Comprehensive Guide
Combination products, also known as combination medical devices, are products that combine a drug or biological product with a device to achieve therapeutic, diagnostic, or prophylactic purposes. These products pose unique regulatory challenges due to their dual nature, and the Medical Devices Regulation (MDR) 2017/745 sets forth specific requirements for the regulation of such products.
Overview of Combination Products and MDR
Combination products can be classified into three categories:
1. Drug-device combination products: These are devices that incorporate a drug or biological product to enhance their functionality.
2. Biological-device combination products: These are devices that incorporate a biological product, such as cells, tissues, or genes, to achieve therapeutic purposes.
3. Device-drug combination products: These are devices that incorporate a pharmacological active ingredient.
MDR 2017/745 defines combination products as medical devices that combine drugs, biologicals, or other substances with medical devices. The regulation establishes clear guidelines for the classification, labeling, and compliance of combination products to ensure their safe use by patients.
Regulatory Classification and Labeling Requirements
For combination products, regulatory classification is determined by the primary mode of action. If the devices action is predominant, it will be classified as a medical device under MDR 2017/745. However, if the drug or biological component predominates, it may be regulated as a medicinal product under the European Medicines Agency (EMA).
Key Considerations for Combination Product Manufacturers
Here are some essential points to consider when developing and marketing combination products:
Intended use: Clearly define the intended purpose of the product.
Classification: Ensure accurate classification based on the primary mode of action.
Labeling: Comply with labeling requirements, including warnings, precautions, and instructions for use.
Compliance with device regulations: Fulfill all applicable MDR 2017/745 requirements.
Some critical points to consider when classifying combination products:
Classification of Combination Products: A Step-by-Step Guide
To classify a combination product, manufacturers should follow these steps:
Determine the primary mode of action: Identify which component (device or drug/biological) drives the therapeutic effect.
Assess device-related functions: Evaluate whether the device performs its intended function independently of the drug or biological component.
Consider system integration: If the combination product integrates multiple functions, classify it according to the predominant action.
Labeling Requirements for Combination Products
Accurate labeling is crucial for combination products. Key requirements include:
Intended use: Clearly state the devices intended purpose and therapeutic effect.
Device-specific warnings and cautions: Highlight potential hazards related to the device, such as tissue damage or foreign body reactions.
Pharmacological information: Provide essential pharmacological data, including dosing instructions and contraindications.
Instructions for use: Include comprehensive guidelines for product operation, maintenance, and disposal.
Device-Related Requirements
Combination products must also comply with device-specific requirements:
Design and manufacturing controls: Ensure adherence to relevant MDR 2017/745 standards.
Risk management: Conduct thorough risk assessments to identify potential hazards.
Clinical evaluation: Perform adequate clinical testing to support safety and efficacy claims.
Labeling Requirements for Biological-Device Combination Products
When labeling biological-device combination products, manufacturers must consider the following:
Biological product-specific information: Include relevant data on the biological component, such as gene expression or protein production levels.
Tissue-engineered product information: Provide details on tissue engineering, scaffold design, and potential complications.
Labeling Requirements for Device-Drug Combination Products
For device-drug combination products:
Device-related labeling: Comply with MDR 2017/745 requirements for device-specific labeling.
Pharmacological warnings and cautions: Highlight potential hazards associated with the pharmacologically active ingredient.
QA Section: Additional Insights into MDR for Combination Products
Q1: What is the primary purpose of the MDR Regulation in relation to combination products?
A1: The Medical Devices Regulation (MDR) 2017/745 establishes clear guidelines and requirements for combination products, ensuring their safe use by patients.
Q2: How are combination products classified under the MDR?
A2: Combination products are classified based on the primary mode of action. If the devices action is predominant, it will be classified as a medical device under MDR 2017/745; if the drug or biological component predominates, it may be regulated as a medicinal product.
Q3: What labeling requirements must manufacturers follow for combination products?
A3: Manufacturers must adhere to both device-specific and pharmacological labeling requirements. This includes accurate classification, clear intended use statements, and comprehensive warnings, precautions, and instructions for use.
Q4: How do I determine the primary mode of action in a combination product?
A4: Determine the primary mode of action by identifying which component (device or drug/biological) drives the therapeutic effect. Evaluate device-related functions and consider system integration to ensure accurate classification.
Q5: What are some key considerations for manufacturers when developing and marketing combination products?
A5: Essential points include defining intended use, ensuring accurate classification, complying with labeling requirements, and fulfilling all applicable MDR 2017/745 regulations.
Q6: Can you provide more information on risk management requirements for combination products?
A6: Manufacturers must conduct thorough risk assessments to identify potential hazards associated with the device or biological component. This includes evaluating device-specific risks as well as pharmacological risks related to the active ingredient.
Q7: How do I ensure compliance with MDR 2017/745 requirements for my combination product?
A7: Adhere to relevant standards and guidelines, including design and manufacturing controls, risk management, and clinical evaluation. Consider consulting regulatory experts or conducting thorough reviews of applicable regulations.
The regulatory landscape surrounding combination products is complex, but by understanding the key considerations outlined above, manufacturers can ensure compliance with MDR 2017/745 requirements.
