The concept of borderline products has become central to regulatory affairs in pharmaceuticals, medical devices, and related industries. These products do not fit neatly into a single regulatory category. Their characteristics overlap across medicines, medical devices, cosmetics, or dietary supplements. Regulatory classification determines the applicable rules, approval pathways, post-market obligations, and safety surveillance requirements. Misclassification can create compliance risks, increase costs, and delay market entry.
What are Borderline Products?
Borderline products are items for which regulatory authorities cannot immediately assign a single product category. The classification depends on multiple factors, including the intended use, mode of action, product claims, and scientific evidence supporting the mechanism of effect. For example, a topical formulation may combine cosmetic benefits with pharmacological activity. Similarly, a medical device may contain a biologically active coating, challenging clear assignment. Regulatory guidance emphasizes classification based on scientific justification rather than marketing convenience.
The European Union provides explicit guidance through the Medical Device Coordination Group (MDCG) document 2022-5 Rev.1. This document outlines how regulators determine whether a product qualifies as a medical device or a medicinal product under EU law. Authorities in other regions, including the UK, Canada, and the United States, apply similar principles while considering local legal frameworks.
Key Criteria for Classification of Borderline Products
Regulators focus on several elements when evaluating borderline products:
- Intended Purpose: The primary objective of the product in diagnosis, prevention, treatment, or aesthetic improvement.
- Mode of Action: Whether the product acts pharmacologically, immunologically, metabolically, or mechanically.
- Product Claims: Statements on labelling, packaging, and marketing materials.
- Scientific Evidence: Experimental or clinical data demonstrating how the product achieves its intended purpose.
- Presentation: Formulation, concentration, and design features consistent with the intended category.
If a product exhibits overlapping characteristics, regulators may classify it as borderline. This classification requires detailed scientific justification to determine the regulatory pathway and compliance obligations.
Regulatory Implications
The classification decision dictates regulatory obligations. A product classified as a medicinal product must comply with clinical trial requirements, Good Manufacturing Practices (GMP), pharmacovigilance obligations, and post-marketing surveillance. A medical device classification requires conformity assessments, technical documentation, and device-specific safety evaluations. Cosmetics and supplements have distinct labelling, manufacturing, and safety standards. Misclassification exposes companies to regulatory action, product recalls, or market access delays.
Regulators also differ in their interpretation of borderline products across jurisdictions. A product considered a device in one country may be regulated as a medicinal product in another. Companies must align development and submission strategies with each regulatory authority to ensure compliance.
Strategic Considerations for Manufacturers
Companies developing borderline products must adopt a proactive approach. Key strategies include:
- Early Regulatory Consultation: Engage with authorities to confirm classification before initiating development or submissions.
- Scientific Justification: Prepare comprehensive evidence demonstrating why a product belongs to a specific regulatory category.
- Adaptive Dossier Design: Develop submission materials that can accommodate classification variations across jurisdictions.
- Compliance Planning: Implement quality, safety, and post-market surveillance programs appropriate to the assigned regulatory category.
- Labeling and Claims Alignment: Ensure promotional materials reflect the regulatory classification and comply with legal requirements.
Effective planning reduces regulatory risk, accelerates market entry, and ensures sustainable compliance across multiple markets.
The Role of Regulatory Services Firms
Firms like DDReg provide expertise in managing borderline products. Services include:
- Regulatory pathway advisory and classification assessment.
- Preparation of scientific justification reports and dossier design.
- Alignment of global submissions with regional regulatory requirements.
- Post-market compliance and pharmacovigilance planning.
- Strategic guidance for product lifecycle management in complex regulatory environments.
By addressing classification challenges early, companies mitigate risk, optimize regulatory interactions, and reduce development timelines.
Conclusion
Borderline products represent a critical challenge in regulatory affairs. Their classification impacts submission strategy, manufacturing, post-market surveillance, and overall compliance. Companies must adopt structured, evidence-based approaches to navigate this complexity. Expertise in regulatory science, combined with strategic planning, ensures that borderline products meet global requirements efficiently. For sponsors and manufacturers, early engagement with regulatory authorities and rigorous scientific justification are essential to achieve compliance and market success.