The article outlines the key points related to the regulatory framework for borderline products.
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
The “Guidance on Borderline between Medical Devices and Medicinal Products under Regulation (EU) 2017/745” (MDCG 2022 – 5 Rev. 1) was published by the MDCG in October 2024. This document, though endorsed by the MDCG, does not reflect the official stance of the European Commission and does not carry legally binding authority.
Only the Court of Justice of the European Union holds the power to interpret Union law conclusively.
Understanding Borderline Products
According to the guidance, borderline products fall within the ambiguous space between being classified as medical devices or medicinal products, complicating the implementation and enforcement of Regulation (EU) 2017/745 (MDR) and Directive 2001/83/EC (MPD) for medicinal products. To clarify this distinction, the document addresses definitions, principles, and case examples, providing uniform application guidance for the MDR across the EU.
Definitions of Medical Devices and Medicinal Products
A clear demarcation between medical devices and medicinal products is established primarily through their definitions:
- Medical Device (Article 2(1), MDR): Defined as any tool, apparatus, appliance, software, or material designed by the manufacturer for diagnosing, preventing, monitoring, or treating diseases or disabilities. These devices achieve their primary action through physical means rather than pharmacological, immunological, or metabolic interactions.
- Medicinal Product (Article 1(2), MPD): This is defined as any substance intended to treat or prevent disease or administered to alter physiological functions through pharmacological, immunological, or metabolic actions.
The guidance emphasizes that a product is typically governed by either MDR or MPD, not both, although certain hybrid products may integrate aspects of both regulations.
Key Principles for Determination
Principal Mode of Action and Intended Use:
The principal mode of action is crucial in determining whether a product is classified as a medical device or a medicinal product. Medical devices generally act through physical means, whereas medicinal products function through pharmacological, immunological, or metabolic mechanisms. This distinction applies even if a medical device incorporates substances with ancillary medicinal effects.
Importantly, manufacturers must justify and document the scientific rationale behind their classification decisions, ensuring the product’s intended action aligns with the claimed regulatory category.
Pharmacological, Immunological, and Metabolic Means:
The document clarifies terms used to define medicinal products:
- Pharmacological Action: Refers to a substance’s interaction with body constituents, such as cells, to modulate physiological functions.
- Immunological Action: Involves effects exerted by immune system components, such as cells or molecules, and can include immunomodulation or immune response targeting.
- Metabolic Action: Concerns alterations in biochemical processes that affect physiological or pathological functions.
These definitions assist in categorizing products based on their primary action method, ensuring consistent regulatory classification.
Case-by-Case Assessment for Product Classification
The MDCG guidelines underscore that classification often requires a case-by-case assessment, particularly for products with overlapping characteristics. A product’s intended use and method of achieving its effect play essential roles in determining its classification.
When ambiguity exists, Article 2(2) of the MPD provides a tie-breaker rule, indicating that if a product could reasonably fit under both MDR and MPD definitions, MPD regulations apply exclusively.
Special Considerations
For products used in diagnosis, the MDCG delineates between medical devices and medicinal products. Diagnostic procedures, defined as investigating and interpreting physiological or pathological conditions, qualify products as medicinal if they involve pharmacological, immunological, or metabolic action. In contrast, devices that only assist in procedures without diagnostic intentions may fall under MDR.
Examples include dyes for tissue visualization during surgery without diagnostic intent, marking substances for surgical accuracy, and dental impression materials, each classified as medical devices rather than medicinal products.
Conclusion
In summary, the present guidance serves as a vital reference for regulatory bodies and manufacturers within the EU, ensuring clarity in the borderline area between medical devices and medicinal products. The structured definitions, principles, and detailed classification criteria are intended to foster uniformity across Member States, assisting stakeholders in navigating complex regulatory requirements. Although this document is non-binding in its legal nature, it still plays a vitally important role in the consistent application of MDR across the EU, reinforcing the distinct roles of medical devices and medicinal products in the healthcare sector.
How Can RegDesk Help?
RegDesk is an AI-powered Regulatory Information Management System that provides medical device companies with regulatory intelligence for over 120 markets worldwide. It can help you prepare and publish global applications, manage standards, run change assessments, and obtain real-time alerts on regulatory changes through a centralized platform. Global expansion has never been this simple.
