The new article further describes the applicable regulatory considerations, paying additional attention to the key concepts used in the context of borderline products in order to ensure the relevant regulations are applied properly.
Table of content
The Medical Device Coordination Group (MDCG), an organization composed of representatives of all Member States and focused on further improvement of the existing legal framework, has published a guidance document dedicated to the borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on medical devices. The document provides an overview of the applicable regulatory requirements, as well as additional clarifications and recommendations to be taken into consideration by medical device manufacturers and other parties involved in order to ensure compliance.
At the same time, provisions of the guidance are non-binding in their legal nature, nor are they intended to introduce new rules or impose new obligations, and could also be subject to changes, should such changes be reasonably necessary to reflect corresponding regulatory developments.
Introduction
Another section of the guidance document, focusing on the criteria and definitions for medical devices under the Medical Device Regulation (MDR), provides decision-making tools to help determine if a product meets the MDR’s definition of a medical device. The main purpose is to establish a consistent approach when distinguishing medical devices from medicinal products, particularly for products that contain substances that, if used independently, might be classified as medicinal.
Determining if a Product Fulfills the Definition of a Medical Device
In particular, the guidance provides a decision tree in order to assist the parties involved in assessing whether a product aligns with the MDR definition of a medical device. This tool is designed for case-by-case evaluations, allowing stakeholders to make consistent, well-supported decisions regarding a product’s classification.
Understanding “A Substance Which, If Used Separately, Would/May/Can Be Considered a Medicinal Product”
The former Directive 93/42/EEC introduced criteria for devices incorporating substances with medicinal properties. Specifically, products integrating a substance with an ancillary action were assessed under the Directive, categorizing them as Class III, the highest-risk classification.
While the MDR retains this principle, it refines the language, removing the conditional phrase “liable to act upon the body”, which implies that ancillary action is required, not optional. In line with Article 1(8) of the MDR, products containing a substance that could independently be classified as a medicinal product and has ancillary action to the device are regulated under MDR, necessitating safety and usefulness verification based on Directive 2001/83/EC standards.
This section clarifies that the manufacturer’s intended use, the amount of the substance, and the delivery method do not alter the classification if the substance inherently meets medicinal criteria.
Concept of “Action Ancillary to that of the Device”
The MDR specifies that a device’s substance with an ancillary role must support the device’s main function, typically by interacting with human tissues or body fluids. This concept is significant in determining whether a product falls under MDR or Directive 2001/83/EC.
Moreover, under MDR’s Rule 14, products with such ancillary substances receive a higher-risk classification (Class III) and undergo additional consultations to ensure compliance with quality and safety standards. The guidance interprets “ancillary” as supporting the primary function, which must be scientifically demonstrable, independent of the manufacturer’s stated intent.
For example, substances fixed in a device that does not interact with body tissues do not qualify as having ancillary action. At the same time, substances that interact in small quantities, aiding the device’s medical purpose, are classified under MDR.
Manufacturers must provide robust scientific data demonstrating whether a substance in the device has ancillary action. Simple assertions do not suffice; manufacturers must offer documented proof if they claim a substance does not possess ancillary action.
In such cases, no benefits of the substance should be promoted on labeling or marketing materials.
Examples of Products and Classifications
In order to assist the parties involved, the guidance also provides several examples illustrating the way the regulatory approach described in the document should be applied. These examples cover different categories of healthcare products addressed in the guidance.
Medical Devices
Products primarily acting through physical mechanisms, even when containing medicinal substances for support, are generally classified as medical devices. Examples include:
- Bone cements, dental fillings, and tissue adhesives: These devices rely on physical structure, with any medicinal action being secondary.
- Wound dressings and haemostatic products: If the device’s function, such as clot formation, is a physical action, they qualify as medical devices.
Accessories to Medical Devices
Certain products specifically assist a medical device without fulfilling a therapeutic function, making them “accessories” under MDR. Examples include contact lens solutions and endoscope lubricants; such products are used in conjunction with devices but do not have independent therapeutic roles.
Medicinal Products
In contrast, some products possess pharmacological, immunological, or metabolic actions as their primary function, thereby categorizing them as medicinal products. These include spermicidal preparations, anesthetic gasses, and intravenous fluids. Their primary action is medicinal, and they interact with the body’s biochemistry rather than serving as a support to a device’s function.
Conclusion
In summary, the guidance provides a structured approach to identifying whether a product meets the criteria of a medical device or medicinal product under MDR. It clarifies that ancillary action is an objective determination based on scientific evidence, requiring manufacturers to document and justify their product’s intended actions. This ensures consistency in product classification and alignment with the EU’s regulatory framework for medical devices and medicinal products.
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