MDCG 2022-5 revision 1 Guide: Clarification and Requirements for the Compliance of Medical Devices and Medicinal Products in Europe

MDCG 2022-5 Guide: Clarifying the Boundaries between Medical Devices and Medicinal Products

The MDCG 2022-5 Guide provides essential guidelines for identifying products at the intersection of medical devices and medicinal products under the European Regulation 2017/745 (MDR). This 2024 update is a key tool for manufacturers and healthcare professionals regarding product qualification and classification in the EU market.

Due to innovations in healthcare, distinguishing between medical devices and medicinal products can sometimes be complex. The Medical Device Coordination Group (MDCG), in collaboration with the European Commission and industry experts, developed this guide to clarify these criteria and ensure uniform application of regulations throughout the European Union.

Primary Objectives of the MDCG 2022-5 Guide:

• Standardize product classification to avoid regulatory ambiguities.
• Assist manufacturers in evaluating their products in line with the requirements of Regulation (EU) 2017/745.
• Prevent qualification errors that could delay market entry or lead to non-compliance issues.

Objectives and Scope of the MDCG 2022-5 Guide

The MDCG 2022-5 Guide is a reference document developed by the Medical Device Coordination Group (MDCG) in collaboration with the European Commission and national authorities. Its purpose is to clarify the regulatory boundaries between medical devices and medicinal products within the framework of European Regulation 2017/745 (MDR), a key factor in ensuring the compliance of healthcare products on the European market.

Objectives of the MDCG 2022-5 Guide:

The guide primarily aims to:

• Eliminate classification ambiguities for products on the borderline between medical devices and medicinal products, often referred to as “borderline” products.
• Provide manufacturers and industry players with clear criteria for product qualification, focusing on the main mode of action (physical or pharmacological).
• Ensure consistent application of regulations across all EU member states, thereby facilitating market access and product safety for end-users.

Scope of the MDCG 2022-5 Guide:

The MDCG 2022-5 Guide covers a variety of healthcare products, from traditional medical devices to combined products. The guide’s scope specifically includes:

• Substance-based medical devices: for example, products applied to the skin or introduced into the body, where the main action is physical.
• Products with ancillary pharmacological action: some devices may incorporate substances with a pharmacological action, though this is not the primary mode of action. The guide helps determine whether these products should be governed by Regulation (EU) 2017/745 or medicinal product standards.
• Products based on herbs and natural substances: the guide provides specific criteria to determine whether a product containing natural extracts should be classified as a medical device or a medicinal product.

Defining Key Terms: Medical Device vs. Medicinal Product According to the MDCG 2022-5 Guide

The MDCG 2022-5 Guide clarifies essential definitions to distinguish a medical device from a medicinal product, in line with Regulation (EU) 2017/745. This distinction is primarily based on the main mode of action and intended use of the product. For manufacturers and healthcare professionals, understanding these differences is crucial for ensuring the regulatory compliance of their products in the European market.

What is a Medical Device?

Any instrument, software, or other article intended for prevention, treatment, or diagnosis without relying on pharmacological, immunological, or metabolic actions (although these may be secondary). The main mode of action of a medical device is physical or mechanical, without recourse to pharmacological, immunological, or metabolic means, even if these might be secondary. This includes actions like protection, stabilization, replacement of anatomical structures, or assisting organ function.

Check also our article named What is a Medical Device.

What is a Medicinal Product?

Any substance or combination of substances intended to modify physiological functions, establish a diagnosis, or treat diseases through pharmacological, immunological, or metabolic action. If the main mode of action is pharmacological, immunological, or metabolic, the product is classified as a medicinal product. For example, products acting directly at the cellular or molecular level to influence a physiological function are medicinal products.

Medical Devices vs. Medicinal Products: Key Distinctions

The MDCG 2022-5 Guide emphasizes the product’s mode of action as the primary criterion for classification. In cases of uncertainty, the guide encourages a thorough assessment of the product based on its active components and their role:

• If the product acts through a physical or mechanical means, it is more likely to be classified as a medical device.
• If the product acts through pharmacological or immunological interaction with the human body, it will be classified as a medicinal product.

These definitions are central to the classification process and aim to reduce ambiguity for “borderline” products—those that share characteristics with both categories.

2024 Update to the MDCG 2022-5 Guide: Key Changes and Enhancements

The 2024 update to the MDCG 2022-5 Guide introduces significant changes to further clarify the distinction between medical devices and medicinal products. Published by the Medical Device Coordination Group (MDCG), this revised guide is designed to meet the needs of manufacturers and industry stakeholders, taking into account evolving European regulations and the unique challenges posed by borderline products.

What’s New in the 2024 Version of the MDCG 2022-5 Guide

Changes introduced by the update include:

• Precise New Definitions: Key terms such as pharmacological, immunological, and metabolic have been redefined to better guide manufacturers in the qualification of their products. This facilitates a clearer understanding of the classification of medical devices and medicinal products.
• Improved Practical Examples: The 2024 version includes additional examples to illustrate common and specific cases of borderline products. These examples help manufacturers understand how combined devices and substance-based products should be classified.
• Updated Classification Criteria: Specific criteria have been added for medical devices incorporating active substances. The guide clarifies how these substances should be evaluated and whether their action is considered primary or secondary.

Changes in Product Qualification Criteria

The 2024 update to the MDCG 2022-5 Guide also clarifies qualification criteria for certain types of products:

• Combined Medical Devices: For devices combining an apparatus with a medicinal substance, the guide clarifies that classification depends on the primary mode of action of the active substance. If this action is secondary, the product may be qualified as a medical device.
• Products Based on Natural Substances: Devices containing plant extracts or natural substances may be classified as medical devices provided their main action is not pharmacological.
• New Documentation Requirements: Manufacturers are now required to include scientific justifications based on the latest data to demonstrate that their product meets regulatory requirements.

How to Determine the Status of a Product: Criteria of the MDCG 2022-5 Guide

The MDCG 2022-5 Guide provides clear criteria to help manufacturers determine whether a product is a medical device or a medicinal product under European regulations. This section focuses on the decision-making process highlighted by the guide and the steps to ensure compliant regulatory classification.

1. Evaluate the Product’s Primary Mode of Action

The primary mode of action is the decisive criterion for determining whether a product is a medical device or a medicinal product. The MDCG 2022-5 Guide clarifies:

• Medical Device: If the product exerts its effect through physical means (e.g., mechanical, physical barrier, lubrication), it is considered a medical device.
• Medicinal Product: If the product acts via pharmacological, immunological, or metabolic action, it falls under the category of medicinal products.

2. Identify Active Substances and Their Role

Products incorporating active substances must be evaluated based on the action of these substances:

• If the active substance has a pharmacological action but is secondary to the primary mode of action (e.g., an antibacterial coating on a device), the product may be classified as a medical device.
• However, if the active substance plays a primary role in the product’s action, it will be classified as a medicinal product.

3. Consider the Indication and Claimed Use

Indications and claimed uses also play a role in classification:

• If the product is explicitly intended for diagnostic, therapeutic, or physical treatment purposes (e.g., mechanical support, anatomical function compensation), it is generally considered a medical device.
• In cases of ambiguity, the guide recommends a detailed analysis of the product documentation and indications, along with a scientific justification for the chosen classification.

4. Application of the MDCG 2022-5 Qualification Process

The MDCG 2022-5 Guide proposes a decision-making process to help manufacturers qualify their products correctly:

• Step 1: Determine the product’s intended use (diagnosis, treatment, monitoring).
• Step 2: Identify the primary mode of action (physical or pharmacological).
• Step 3: Evaluate active substances and their role in the product.
• Step 4: Confirm the chosen classification with scientific evidence and document it in the technical file.

Practical Examples: Borderline Products between Medical Devices and Medicinal Products

The MDCG 2022-5 Guide includes concrete examples to illustrate the classification of borderline products—those at the intersection of medical devices and medicinal products. These examples are essential for manufacturers as they demonstrate how to apply qualification criteria to ensure regulatory compliance.

1. Medical Devices with Physical Action: Practical Examples

Certain products are classified as medical devices due to their physical or mechanical mode of action:

• Hemostatic Dressings: These devices, made from materials such as calcium alginate or oxidized cellulose, stop bleeding through physical action, without pharmacological intervention.
• Mechanical Irrigation Solutions: Used in ophthalmology or urology, these solutions work by physically rinsing the application area, without medicinal action.

These examples show that, even if substances are present in the product, they only play an ancillary role, which allows them to be classified as medical devices.

2. Medicinal Products with Pharmacological Action: Typical Examples

For other products, classification as a medicinal product is required due to the pharmacological action of their active substances:

• Anesthetic Gases: Although their application may involve a device, these gases produce a pharmacological effect on the patient and are therefore classified as medicinal products.
• Diagnostic Imaging Agents: For example, contrast agents for medical imaging are used to enhance internal visualization by acting pharmacologically, which classifies them as medicinal products.

These examples show how the main pharmacological or metabolic action of a product determines its classification as a medicinal product.

3. Combined Devices: Practical Cases of Products Incorporating Medicinal Substances

The MDCG 2022-5 Guide provides specific examples for devices that incorporate medicinal substances, where the substance plays an ancillary role:

• Bone Cement Containing Antibiotics: Although the antibiotic is included to prevent infections, the main action remains physical, as the cement mechanically supports the bones. This type of product is therefore classified as a medical device.
• Catheters Coated with Antimicrobial Agents: Here, the antimicrobial coating is present to reduce the risk of infection, but the catheter primarily serves a physical function of fluid transport.

These examples of medical devices with integrated medicinal substances show that if the pharmacological action is secondary, the product can be classified as a medical device.

4. Natural Substance-Based Products: Classification Examples According to the MDCG Guide

Devices containing natural substances, such as plant extracts, can also be classified based on their mode of action:

• Moisturizing Eye Gels: When they only provide a moisturizing effect without direct pharmacological impact, these gels can be classified as medical devices.
• Oral Cough Treatments: If a cough treatment works solely by physical effect (such as coating the throat), it can be classified as a medical device. Conversely, if the action is pharmacological, the product will be classified as a medicinal product.

These examples demonstrate how the guide addresses natural products and their effects for proper classification.

Medical Devices Incorporating Medicinal Products: Rules and Requirements of the MDCG 2022-5 Guide

The MDCG 2022-5 Guide specifically addresses medical devices incorporating medicinally active substances, also called combined devices. These products often lie on the borderline between medical devices and medicinal products, and their classification requires a deep understanding of European regulatory rules. In this section, we explore the rules and compliance requirements for medical devices incorporating active substances, as outlined in the guide.

1. Definition of Medical Devices Incorporating Medicinal Substances

Medical devices incorporating medicinal substances are devices that, although their primary mode of action is physical or mechanical, contain a substance with an ancillary pharmacological, immunological, or metabolic effect. This substance may be incorporated for safety reasons or to enhance the device’s performance, without being the primary mode of action.

Examples of common combined devices:

• Catheters coated with antibiotics to prevent infections
• Bone implants containing growth substances to promote healing
• Bone cements with antibacterial agents to reduce the risk of post-operative infection

2. Classification Criteria for Combined Devices according to the MDCG 2022-5 Guide

The MDCG 2022-5 Guide clarifies the criteria for determining whether a combined device should be classified as a medical device or a medicinal product. Key points include:

• Primary Mode of Action: If the primary action of the device is physical (e.g., mechanical support or physical barrier), the product is classified as a medical device.
• Ancillary Action of the Substance: If the active substance has an ancillary, rather than primary, action, the product remains classified as a medical device. For instance, an antimicrobial coating on an implant does not affect the implant’s primary support function.

However, if the active substance exerts a primary pharmacological action (e.g., continuous drug release), the product could be classified as a medicinal product. The guide provides examples to help manufacturers apply these criteria appropriately.

3. Compliance Requirements for Medical Devices with Medicinal Substances

Devices with integrated medicinal substances must meet specific requirements for both safety and performance. According to the MDCG 2022-5 Guide:

• Scientific Justification and Documentation: Manufacturers must demonstrate, with scientific data, that the substance only affects the primary mode of action secondarily. This justification should be included in the product’s technical file.
• Risk Assessment: The guide recommends a thorough risk assessment related to the integration of active substances, taking into account their interaction with the device and any potential effects on the patient.
• Consultation with Competent Authorities: In certain cases, the manufacturer may be required to consult competent health authorities, such as the European Medicines Agency (EMA), for an additional evaluation of the compliance of the active substance.

4. Specific Classification Rules and Annex Rules

The MDCG 2022-5 Guide proposes specific classification rules for combined devices:

• Class III: Any device incorporating a substance that, if used alone, would be considered a medicinal product is generally classified as Class III, the highest risk category. This ensures a more rigorous conformity assessment for devices with significant health impacts.
• Additional Requirements for Systemically Absorbed Substances: If the integrated substance is absorbed systemically by the human body, specific consultation and evaluation requirements apply to ensure patient safety.

Importance of the MDCG 2022-5 Guide Requirements for Combined Medical Devices

By following the rules and requirements of the MDCG 2022-5 Guide, manufacturers of combined medical devices can ensure that their products meet European compliance standards while maximizing their safety and effectiveness for end users. These rules are crucial for quality managers and R&D teams, providing a solid framework for managing high-risk devices.

Importance of the MDCG 2022-5 Guide for Manufacturers of Medical Devices and Medicinal Products

The MDCG 2022-5 Guide has become an essential document for manufacturers of medical devices and medicinal products in Europe. By clarifying product qualification criteria and providing concrete examples, it helps companies ensure their products comply with European regulations. In a context where classification errors can significantly impact market access and patient safety, this guide is a strategic resource.

1. Why the MDCG 2022-5 Guide is Essential for Manufacturers

The guide helps manufacturers better understand medical device regulations and ensure that their products meet the requirements of Regulation (EU) 2017/745. Key benefits for companies include:

• Reduced Non-Compliance Risks: Misclassification can lead to recalls, fines, and even sales bans. By following the guide, manufacturers limit these risks by adhering to clear criteria.
• Faster Access to the European Market: By classifying products correctly from the outset, companies can avoid delays due to additional evaluations or reclassification, allowing for faster market access.
• Improved Product Safety: The guide provides precise safety criteria for combined devices and borderline products, contributing to end-user protection.

2. Benefits of the MDCG 2022-5 Guide for Quality and Regulatory Managers

For quality and regulatory compliance managers, the MDCG 2022-5 Guide is a practical tool that facilitates the interpretation of European Union requirements for each product category. The guide allows them to:

• Structure the Technical File: By providing recommendations on scientific documentation and classification justifications, the guide helps build a compliant and complete technical file, essential for audits and certification.
• Better Manage Combined Devices: Products that combine medical devices and medicinal substances are complex to manage from a regulatory perspective. The guide provides clear guidelines for evaluating these products, reducing ambiguities, and ensuring all safety requirements are met.
• Anticipate Consultation Needs with Authorities: For certain devices incorporating active substances, the guide recommends consultations with authorities such as the EMA, which helps managers anticipate compliance needs.

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Since the introduction of Regulation 2017/745, new requirements are expected and are part of the documentation presented to the notified body (for instance, in-depth clinical evaluation reviews, PMS procedures, CQ results from product validation, evidence of staff competencies, etc.).

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