New MDCG 2024-11 Guide: Qualification of In Vitro Diagnostic Medical Devices (IVD)

The Medical Device Coordination Group (MDCG) has released a new guide, MDCG 2024-11, providing essential advice on the qualification of in vitro diagnostic (IVD) medical devices under the European IVDR regulation. This document is crucial for manufacturers and healthcare professionals seeking to ensure that their products meet regulatory requirements.

1. Context and Objective of the Guide

Regulations on medical devices are constantly evolving to ensure the safety and effectiveness of products in the European market. Regulation (EU) 2017/746 (IVDR) aims to enhance the transparency and quality of devices used for diagnostics. However, qualifying a product as an in vitro diagnostic medical device (IVD) or an accessory can be challenging for manufacturers. The MDCG 2024-11 guide, published on October 8, 2024, provides essential clarifications on this matter. It helps to identify which devices and accessories fall under the scope of the IVDR based on their intended use. This guide is designed to assist manufacturers, healthcare professionals, and regulatory authorities in the correct qualification of products.

2. Key Concepts for IVD Qualification

Section 1 of the MDCG 2024-11 document is titled "General Principles of Qualification" and is divided into two main subsections. This section clearly defines what an IVD is, detailing the specific criteria that determine whether a product falls under the IVDR. It also highlights the differences between medical devices used for in vivo and in vitro diagnostics while emphasizing the importance of the manufacturer’s intent in determining the correct classification of the product.

The distinction between IVDs and medical devices is essential to ensure that manufacturers follow the correct regulations based on the intended use of their products.

1.1 Definition of Medical Devices and In Vitro Diagnostic Devices (IVD)

The MDCG 2024-11 guide clarifies the differences between a medical device (MD) and an in vitro diagnostic medical device (IVD), based on the definitions in Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR).

Definition of IVDs (Article 2(2) of the IVDR): An IVD is a device designed by the manufacturer to be used outside the human body (in vitro) to analyze biological samples (blood, tissues, etc.) from the human body. Its main purpose is to provide medical information, such as:

• A physiological or pathological process (e.g., disease screening tests),
• Congenital physical or mental impairments (e.g., detection of trisomy 21),
• A predisposition to a medical condition or disease (e.g., genetic tests),
• Compatibility with potential recipients (e.g., HLA typing for transplants),
• Treatment response or potential reactions (e.g., drug reaction tests),
• The definition or monitoring of therapeutic measures (e.g., blood glucose monitoring).

Sample receptacles specifically designed to contain or preserve human specimens for in vitro analysis are also considered IVDs.

Definition of medical devices (Article 2(1) of the MDR): A medical device is any instrument, apparatus, software, or other article intended to be used in humans, alone or in combination, for medical purposes such as diagnosis, treatment, or monitoring of diseases. Unlike IVDs, these devices are often used in vivo (inside the human body) or on the human body.

1.2 Essential Characteristics of an IVD

For a product to qualify as an IVD, it must meet certain essential characteristics:

1. Type of product: An IVD can be a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, piece of equipment, software, or a complete system. It may be used alone or in combination with other devices.

2. In vitro use: The IVD is intended for use in vitro, meaning it is used outside the human body to examine samples such as blood or tissues. Once collected, these specimens are not reintroduced into the body.

3. Medical purpose: The primary function of the IVD is to provide medical information, which may be used for:

• Identifying physiological or pathological processes (e.g., disease screening tests),
• Detecting congenital impairments (e.g., newborn trisomy 21 screening),
• Diagnosing predisposition to a medical condition (e.g., genetic tests for cancer risk),
• Verifying compatibility between donors and recipients (e.g., blood testing for transplants),
• Anticipating treatment response (e.g., tests for drug reactions),
• Monitoring ongoing treatment (e.g., glucose level monitoring).

4. Multiple purposes: A product may have several intended purposes. If one of these purposes is to provide medical information (as defined in Article 2(2) of the IVDR), the product must comply with the IVDR.

5. Exclusion of non-medical products: Products whose primary purpose is not medical, such as tests for ancestry determination or those for sport or wellness purposes, are not considered IVDs.

3. Specific Topics on Qualification

The MDCG 2024-11 guide addresses several specific topics that require particular attention when determining whether a product qualifies as an in vitro diagnostic medical device (IVD) or not. These topics cover various types of devices, accessories, and situations that may need clarification regarding their status under the IVDR regulation. Here's an overview of the key topics covered:

1. Accessories

Accessories play an important role in the functionality of IVD devices. According to the IVDR, an accessory is an article that, although not an IVD itself, is intended to be used with one or more IVD devices to enable their proper functioning. A typical example would be a cleaning solution specifically designed for an automated IVD instrument. These accessories must also comply with IVDR requirements.

2. Sample Receptacles and Specimen Collection Products

Sample receptacles, such as blood collection tubes or urine containers, are qualified as IVDs if they are specifically designed for the collection, transport, or preservation of human samples for in vitro diagnostic purposes. In contrast, collection devices that come into direct contact with the human body, such as needles or scalpels, fall under the Medical Device Regulation (MDR).

3. Devices Without a Specimen

Some diagnostic devices operate without the need for a human sample. If a device does not handle human samples, it cannot be classified as an IVD. An example is a glucose measurement device that uses external sensors on the skin. These devices are classified as medical devices under the MDR.

4. General Laboratory Products

Products commonly used in laboratories, such as pipettes or centrifuges, are not automatically considered IVDs. However, if a product is specifically designed for use in in vitro diagnostics, such as an ELISA plate coated with a specific antigen, it must be qualified as an IVD and meet the corresponding requirements.

5. Research-Only Products (RUO)

Products labeled as "Research Only" (RUO) are not covered by the IVDR as long as they are not intended for medical purposes. However, if they are used in in vitro diagnostic processes to provide medical information, they must comply with the IVDR.

6. IVD Kits and Product Combinations

IVD kits, consisting of multiple components packaged together to perform a specific in vitro diagnostic test, are also governed by the IVDR. Each component of the kit may be qualified separately, but the kit as a whole must also comply with IVDR requirements. The guide distinguishes IVD kits from "procedure packs," which may contain medical devices but are not qualified as IVDs.

7. Software

Software, especially those used to interpret diagnostic results, can be qualified as IVD devices if they provide medical information based on human specimens. For further clarity, the guide also refers to specific guidelines on the qualification of software as medical devices or IVDs.

8. Other Specific Topics

The guide also covers other specific categories such as microbiological culture media, stains used for in vitro testing, tests used in industrial production, as well as those used in the context of biological or chemical warfare and forensic tests. In each case, qualification depends on the product’s specific use.

4. Key Points for Manufacturers and Industry Professionals

The MDCG 2024-11 guide offers crucial guidance for manufacturers of in vitro diagnostic medical devices (IVD), helping them better understand regulatory requirements and ensure their products comply with the European market standards. Here are the key takeaways for manufacturers and industry professionals:

1. Qualification based on intended use:

An IVD is defined by its intended medical use. Documentation (labels, instructions, etc.) must clearly state this purpose to ensure compliance with IVDR requirements.

2. Accessories and compliance:

Accessories intended for use with IVDs must also comply with the IVDR. Incorrect classification can result in costly non-compliance issues.

3. Laboratory and research products:

General laboratory products or “research-only” (RUO) items are not considered IVDs unless they are explicitly intended for medical diagnostic use.

4. Compliance of IVD kits:

IVD kits, composed of multiple components, must comply with IVDR as a whole, with each element individually assessed for compliance.

5. Software and digital devices:

Software used to interpret medical results can qualify as IVDs and must meet IVDR requirements.

6. Combined devices:

Devices combining both IVD components and medical devices (MD) must comply with both regulations (IVDR and MDR).

7. Documentation and transparency:

Clear and complete documentation is essential for ensuring compliance. It should include details on performance, risks, and the intended use of the product.

8. Post-market surveillance:

Manufacturers are required to monitor the safety and performance of their devices after they are placed on the market and take corrective actions when necessary.

5. Conclusion and Next Steps

The MDCG 2024-11 guide is a valuable resource for manufacturers of in vitro diagnostic medical devices (IVD) and industry professionals. It provides clear guidelines on how to properly qualify devices and ensure that each product complies with the requirements of Regulation (EU) 2017/746 (IVDR). With the help of this guide, companies can better navigate the complexities of the regulatory framework, understand the distinctions between different types of devices, accessories, and products used in in vitro diagnostics.

Next Steps for Manufacturers and Industry Professionals:

1. Product Assessment: Manufacturers should reassess their product portfolio in light of the clarifications provided by this guide. This includes verifying whether each product meets the definitions of IVDs and accessories, while ensuring that the intended use is well-documented.

2. Updating Compliance Procedures: Manufacturers should review their internal procedures to ensure that each stage of the product lifecycle—from design to market introduction—complies with the guide's recommendations and regulatory requirements. This includes integrating tools for post-market surveillance.

3. Reviewing Documentation: Information provided on labeling, instructions for use, and technical documentation must be reviewed and updated if necessary. Transparency and accuracy in these documents are essential for compliance with the IVDR.

4. Collaboration with Notified Bodies: For devices requiring CE marking, it is recommended to work closely with notified bodies to ensure that products meet the criteria set out in the regulation. A proactive approach can help avoid delays or non-compliance issues.

5. Continuous Training: Compliance, product development, and quality professionals should undergo ongoing training on the latest regulatory developments. A solid understanding of technical and regulatory requirements is essential for staying competitive in the European market.

Anticipating Future Developments

In conclusion, this guide is not an endpoint but an important step in understanding the regulation of IVD devices. The European regulatory framework is constantly evolving, and it is essential for companies to stay up to date with new guidelines, adjustments, and requirements. Compliance is not only a legal obligation, but also an opportunity for manufacturers to improve the safety and performance of their products, thereby strengthening their credibility in the marketplace.

By following these steps and adapting to future changes, companies in the in vitro diagnostics sector will not only meet current requirements but also position themselves as leaders in a growing market.

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