The Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR) provide comprehensive and detailed definitions that clearly outline what qualifies as a Medical Device and an In Vitro Diagnostic Medical Device. These definitions are essential, as they serve as the foundation for determining the regulatory pathway for products within the European Union.
The definitions within the MDR and IVDR help manufacturers, regulators, and stakeholders identify which products fall under these regulatory frameworks. For instance, a Medical Device under the MDR is defined as any instrument, apparatus, appliance, software, implant, or similar product that is intended by the manufacturer for use in humans for specific medical purposes. These include diagnosing, preventing, monitoring, treating, or alleviating disease, as well as compensating for an injury or disability.
Similarly, under the IVDR, an In Vitro Diagnostic Medical Device is defined as any medical device that is intended for the in vitro examination of specimens derived from the human body. These devices are used to provide information about a person’s physiological or pathological state, congenital conditions, predispositions to a medical condition, or to monitor therapeutic measures. The IVDR covers a wide range of diagnostic tools, from simple blood glucose tests to complex laboratory diagnostic tests.
The importance of these definitions goes beyond a simple description. They provide manufacturers with a clear framework for determining whether their product is governed by the MDR or the IVDR. A key benefit is that these definitions offer a systematic approach to qualifying products, ensuring that devices that have a medical purpose and those that are used for diagnostic purposes are correctly identified and regulated.
Let’s consider the example of a wheelchair. There is no debate about whether this device qualifies as a medical device, as it clearly meets the definition. A wheelchair compensates for a physical impairment or disability, assisting individuals with mobility issues. The device serves an obvious medical purpose, making its classification under the Medical Device Regulation (MDR) straightforward.
Similarly, take the case of a COVID-19 rapid test. There is no question that this product falls under the scope of the In Vitro Diagnostic Regulation (IVDR), as it provides essential information about a physiological or pathological condition—in this case, the presence of the SARS-CoV-2 virus. The intended use of the test, which directly involves detecting a medical condition, leaves little room for doubt about its classification.
However, not all devices are as easy to classify. Some products can fit within the scope of multiple regulations, making it more difficult for manufacturers to determine which legislation applies. For instance, let’s look at a pre-filled syringe containing a medicinal substance. Here, the situation becomes more complex. Is the product regulated as a medical device, since it involves the physical delivery of the medication? Or is it classified as a medicinal product due to the pharmacological action of the drug it contains? This overlap makes it challenging for manufacturers to determine the primary legislation under which the product should be governed.
These types of products are referred to as borderline products in the field of medical devices. They often present significant classification challenges due to their dual nature or overlapping characteristics. Borderline products have a long history of causing regulatory confusion, and misclassification can lead to serious consequences, such as delayed market entry, increased costs, or even product recalls. Getting the classification wrong can also lead to further regulatory scrutiny, and in some cases, legal penalties for non-compliance.
To help navigate the complex classification of borderline products, manufacturers can turn to guidance documents published by working groups within the EU. These documents provide critical insights and clarifications on how to assess products that sit at the intersection of multiple regulatory frameworks. In recent years, the publication of these guidance documents has become an invaluable tool for companies struggling to classify their products accurately. As of the time of writing, there are five key guidance documents specifically aimed at helping manufacturers determine the correct qualification for their borderline products. These resources play an important role in supporting compliance and ensuring a smoother path to market.
By consulting these guidance documents, manufacturers can better understand the nuances of borderline classifications and avoid regulatory pitfalls, allowing for more efficient product development and faster market access.
Guidance 1: MANUAL ON BORDERLINE AND CLASSIFICATION IN THE COMMUNITY REGULATORY FRAMEWORK FOR MEDICAL DEVICES
The first guidance document was released in 2019, and although it references earlier regulations such as the Medical Device Directive (MDD), In Vitro Diagnostic Directive (IVDD), and Active Implantable Medical Devices Directive (AIMDD), it remains a valuable resource today. To use it effectively under the current regulatory framework, manufacturers need to apply its principles in line with the updated Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).
The reason this document continues to be relevant is that it provides numerous practical examples of devices that fall under various regulatory frameworks, particularly borderline products—devices that could be subject to multiple types of legislation. These examples help clarify the classification challenges faced by manufacturers and regulators alike.
The document covers a wide range of borderline device categories, including:
- Borderline Medical Devices vs. Medicinal Products
- Borderline Medical Devices vs. Biocides
- Borderline Medical Devices vs. Cosmetic Products
Consider an example from the guidance document: a plaster containing capsaicin. At first glance, one might classify this as a medical device, assuming its primary function is simply to cover a wound.
That being said, we need to look further into this, especially the substance being used. Capsaicin is derived from chili peppers and can provide pain relief when applied topically to muscles and joints. The European Scientific Cooperation on Phytotherapy (ESCOP) has recognized “Capsici fructus” (the chili pepper fruit) as an herbal medicinal product, which supports classifying capsaicin as a medicinal substance. As such, the presence of capsaicin might lead one to classify the device as a medicinal product.
In such cases, qualification depends on intended use. If the plaster is primarily intended to function as a wound cover, it would be regulated as a medical device. Due to the capsaicin content, it would likely be classified as a Class III device under Rule 14 of the MDR, which applies when a device contains a medicinal substance with an ancillary effect.
Conversely, if the plaster’s main purpose is to deliver capsaicin for pain relief, it would be classified under the Medicinal Product Directive, with the plaster acting only as a carrier for the medicinal substance.
Guidance 2: Manual on borderline and classification for medical devices under Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices
The second guidance document is the MDR and IVDR equivalent of the previously discussed document. It provides different examples highlighting the following borderline products:
- Borderline Medical Devices vs. Medicinal Products
- Borderline Medical Devices vs. Biocides
- Borderline Medical Devices vs. Personal Protective Equipment
Importance of Intended Use
This guidance document highlights the importance of the intended use statement when it comes to borderline Medical Device – Personal Protective Equipment products.
One of the examples that are given in this document is Plexiglas box for caregiver protection. The product is a safety box intended to prevent caregivers from being exposed to infection (i.e.
COVID-19) by containing droplets expelled by the patient during endotracheal intubation,
tracheotomy or any airway related procedure. The document states that a medical device has the aim to provide protection of health and safety of the patient. A product solely intended to protect a caregiver or health care professional by preventing exposure during a medical or surgical procedure, should not be qualified as a medical device, putting this device in the PPE category.
If we apply this line of thought to Medical Masks, we can see how the intended use plays a major role in determining which legislation the device would fall under. Based on the intended use, the device can fall into the following three categories:
Medical Device (MDR) (EU) 2017/745)
- Intended Use: Medical masks classified under the MDR are primarily intended to protect patients or third parties from the risk of infection, especially in surgical or clinical environments. Their primary function is to act as a barrier that prevents the transmission of infectious agents from the wearer to the patient, or from the environment to the wearer, particularly during surgical procedures.
- Example: Surgical masks or masks worn by healthcare professionals during operations. These masks are designed to prevent the spread of bacteria or viruses from the wearer’s mouth and nose to the surrounding environment or the patient.
Personal Protective Equipment (PPE) (EU) 2016/425)
- Intended Use: Masks classified under the PPE Regulation are primarily designed to protect the wearer from external risks such as dust, hazardous particles, or biological agents. These masks are often used in industrial settings or environments where the wearer is at risk of inhaling harmful airborne particles or infectious agents.
- Example: FFP2 or FFP3 respirator masks, which are designed to filter airborne particles and protect the wearer from inhaling harmful substances such as dust, chemicals, or infectious agents (e.g., in environments with exposure to COVID-19 or other pathogens).
Dual-Use Masks (PPE and MDR)
- Some masks may fall under both regulations if they are intended to protect both the patient and the wearer. For example, in healthcare settings during a pandemic, a mask may serve the dual function of protecting both the patient from infection and the healthcare worker from airborne particles. In such cases, the product must comply with the requirements of both the MDR and PPE regulations, and both CE markings may be required.
Guidance 3: MDCG 2022 – 5 rev1 Guidance on borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on medical devices
This guidance document was originally released in 2022 and provides valuable guidance on the distinction between Regulation (EU) 2017/745 on medical devices (MDR) and Directive 2001/83/EC on the Community code for medicinal products for human use (MPD) is essential for the effective implementation, interpretation, and enforcement of these legal frameworks.
Both the MDR and MPD include provisions to define this boundary. This document offers additional explanations and examples to clarify these provisions, aiming to promote the consistent application of the MDR throughout the EU.
The document begins with a general overview of the borderline between medical devices and medicinal products, including relevant definitions and practical examples. Specific chapters address herbal products, substance-based devices, and combinations of medical devices and medicinal products.
Guidance 4: MDCG 2019-11 Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR
This guidance document was released in 2019 and primarily targets medical software manufacturers. The guidance helps define the criteria for the qualification of software falling within the scope of the MDR and IVDR and provides guidance on the application of classification criteria for software under Regulation (EU) 2017/745 MDR and Regulation (EU) 2017/746 – IVDR. In addition, the guidance also provides information related to placing on the market.
Guidance 5: MDCG 2024-11 Guidance on qualification of in vitro diagnostic medical devices
The MDCG has recently published a guidance concerning the qualification of in vitro diagnostic medical devices. The purpose of this guidance document is to clarify what products fall in scope of Regulation 2017/746 on in vitro diagnostic medical devices (IVDR) or an accessory to an IVD. This guidance document includes non-exhaustive lists of examples of IVDs and accessories to IVDs.
Classification of Device
Once you have determined that your product qualifies as either a Medical Device under the Medical Device Regulation (MDR) or an In-Vitro Diagnostic Medical Device (IVD) under the In Vitro Diagnostic Regulation (IVDR), the next critical step is to properly classify it in accordance with the respective legislation. Proper classification is essential, as it determines the regulatory pathway, the level of scrutiny, and the specific requirements your device must meet before it can be placed on the market.
To assist manufacturers with this process, two key guidance documents released by the Medical Device Coordination Group (MDCG) are invaluable tools:
- MDCG 2021-24: Guidance on Classification of Medical Devices: This document provides detailed guidance on how to apply the classification rules outlined in the MDR. It breaks down each rule in the regulation, explaining how devices are categorized based on their intended use, duration of contact with the body, and level of risk. It also includes specific examples for various device types, making it easier for manufacturers to understand how the rules apply to their products.
- MDCG 2020-16 rev.3: Guidance on Classification Rules for In Vitro Diagnostic Medical Devices under Regulation (EU) 2017/746: For manufacturers of IVDs, this document is crucial. It outlines the classification rules under the IVDR, which categorizes devices into four classes (A, B, C, and D) based on the potential risk they pose to public health and patient safety. The guidance explains the classification process step by step and provides real-world examples to clarify the classification of complex diagnostic tools.
Both of these guidance documents are indispensable for understanding the specific classification rules that apply to medical devices and in vitro diagnostics. They not only explain the technicalities of the classification process but also provide practical examples to help manufacturers interpret and implement the rules correctly.
Concluding thoughts
As a manufacturer, understanding the specific legislation that governs your device is crucial for ensuring compliance and successful market entry. With the rapid pace of medical technology advancements, an increasing number of products are finding themselves in the borderline category, where classification becomes less straightforward. In this evolving landscape, guidance documents have become indispensable resources for both manufacturers and regulators, aiding in the qualification and classification of these complex products.
Here are several important factors to consider when determining the appropriate legislation for your device:
- Intended Use of the Device: Clearly defining the intended purpose of your device is fundamental. This includes understanding the medical conditions it addresses and how it will be used by healthcare professionals or patients. The intended use directly influences classification and regulatory requirements.
- Primary Mode of Action: Assessing the primary mode of action is essential in determining whether a product is classified as a medical device or a medicinal product. Understanding how the device interacts with the body and its primary therapeutic effect can clarify its regulatory pathway.
- Use of Guidance Documents: Leverage the available guidance documents issued by regulatory authorities. These documents provide insights into regulatory expectations and can help clarify the classification process, especially for borderline products. They serve as a valuable reference for manufacturers seeking to navigate complex regulatory environments.
- Knowledge of the Substances Used in the Device: Understanding the materials and substances incorporated into your device is critical. This includes being aware of any regulatory implications associated with specific substances, particularly if they have pharmacological effects or pose safety concerns.
At Advena, we have a dedicated team of experts with extensive experience in classifying medical devices. If you ever find yourself uncertain about which legislation or classification applies to your device, please feel free to reach out to us. Our team is here to provide guidance and support throughout the classification process.
We also encourage manufacturers to engage with us early in the product development lifecycle. By consulting with our experts from the outset, you can ensure a smoother process, effectively mitigating potential roadblocks and enhancing the likelihood of a successful regulatory outcome.
References
Reference documents from this article
| Document Name | Reference |
| MANUAL ON BORDERLINE AND CLASSIFICATION IN THE COMMUNITY REGULATORY FRAMEWORK FOR MEDICAL DEVICES | https://health.ec.europa.eu/system/files/2020-08/md_borderline_manual_05_2019_en_0.pdf |
| Manual on borderline and classification for medical devices under Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices | https://health.ec.europa.eu/system/files/2023-09/md_borderline_manual_en.pdf |
| MDCG 2022 – 5 rev1: Guidance on borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on medical devices | https://health.ec.europa.eu/document/download/b5a27717-229f-4d7a-97b1-e1c7d819e579_en?filename=mdcg_2022-5_en.pdf |
| MDCG 2019-11: Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR | https://health.ec.europa.eu/system/files/2020-09/md_mdcg_2019_11_guidance_qualification_classification_software_en_0.pdf |
| MDCG 2024-11 Guidance on qualification of in vitro diagnostic medical devices | https://health.ec.europa.eu/document/download/12b92152-371f-404d-a865-93800cd5cdca_en?filename=mdcg_2024-11_en.pdf |
| MDCG 2021-24: Guidance on classification of medical device | https://health.ec.europa.eu/system/files/2021-10/mdcg_2021-24_en_0.pdf |
| MDCG 2020-16 rev.3: Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746 | https://health.ec.europa.eu/system/files/2023-02/md_mdcg_2020_guidance_classification_ivd-md_en.pdf |
