This article further elaborates on the key matters associated with substance-based products intended to be marketed and used within the EU.
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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 to Medical Device and Medicinal Product Combinations
Some medical devices are designed for use with a medicinal product, resulting in different regulatory scenarios under the MDR. Articles 1(8) and 1(9) of the MDR define four key regulatory configurations for devices used with medicinal products, depending on whether the medicinal product is an integral or ancillary component. The definition of “integral” is particularly relevant for devices that either incorporate a medicinal substance as an essential part or are intended to administer medicinal products as a single entity.
Integral Combinations of Medical Devices and Medicinal Products
The definition of “Integral” in the MDR Context includes:
- Integral Part (Article 1(8)): A medical device that incorporates a substance (e.g., medicinal or derived from human blood/plasma) as an essential component. The product is an integral combination if the device and substance create a single entity when marketed.
- Single Integral Product (Article 1(9)): Devices intended exclusively to administer a medicinal product, forming a single-use product that cannot be separated before administration.
The document also mentions that devices co-packaged with medicinal products or referenced in related documents without physical integration are not considered “integral” combinations under MDR.
Regulatory Pathways for Integral Product Combinations
As further explained by the MDCG, the regulatory status of an integral combination product depends on the primary action of the incorporated medicinal product:
- If the medicinal product’s action is principal, the entire product is regulated as a medicinal product under Directive 2001/83/EC or Regulation (EC) No 726/2004.
- If the device provides the principal intended action, and the medicinal product’s action is only ancillary, the MDR applies, regulating it as a medical device incorporating an ancillary medicinal product.
Medical Device and Medicinal Product Combinations Regulated as Medicinal Products
This category includes devices that are inseparably combined with a medicinal product, used only as a single unit and not reusable. If the medicinal product’s primary function drives the product’s purpose, it is regulated as a medicinal product.
Safety and performance standards from the MDR still apply to ensure the device components meet relevant requirements.
Examples:
- Prefilled syringes, aerosol cans, and nebulizers with medicinal substances,
- Transdermal patches for drug delivery,
- Drug-releasing implants for localized treatment (e.g., antibiotic plastic beads for infections), and
- Iontophoresis devices designed for single-use medicinal delivery.
Devices for Administering Medicinal Products
Devices intended to deliver a separately provided medicinal product are regulated solely under the MDR. The medicinal product itself remains under Directive 2001/83/EC. These products serve as tools to facilitate drug administration without incorporating the medicinal substance directly.
Examples of such products include, inter alia, drug delivery pumps, implantable infusion pumps, nebulizers, and reusable syringes.
Medical Devices with an Ancillary Medicinal Component
According to the guidance, certain devices incorporate medicinal substances that play a secondary or ancillary role. These products are regulated as medical devices under the MDR, provided the medicinal component is not the primary action.
The MDR requires consultation with competent authorities when the ancillary medicinal component would otherwise be considered a medicinal product if used separately.
Examples:
- Catheters coated with heparin or antibiotics for infection prevention,
- Bone cements containing antibiotics for localized antimicrobial action.,
- Wound dressings with antimicrobial agents where the primary function is wound coverage, and antimicrobial action is secondary.
Herbal Substances in Medical Devices
Some devices may incorporate herbal substances that meet medicinal product criteria. These products require a Class III designation if the herbal component has an ancillary action.
Manufacturers must prove that the herbal substance’s action is indeed secondary to the device’s primary function.
Examples of Herbal Components include:
- Calendula (Marigold) for anti-inflammatory effects,
- Thyme for antiseptic properties,
- St. John’s Wort for pain relief and anti-inflammatory use.
Human Blood or Plasma Derivatives in Medical Devices
Devices containing derivatives from human blood or plasma, such as thrombin-based haemostatic agents, are also subject to Class III designation. These devices serve therapeutic purposes like bleeding control or supporting embryonic culture in IVF.
Examples of such products would be haemostatic agents with thrombin and IVF culture media containing human albumin solution.
Conclusion
In summary, the MDR provides a structured regulatory pathway for devices incorporating medicinal products, either as primary or ancillary components. Integral products whose primary action is medicinal follow medicinal product regulations, while devices with secondary medicinal actions follow MDR guidelines. Through detailed classifications and requirements, the MDR ensures appropriate safety, performance, and compliance standards for complex medical devices with medicinal components.
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