The Borderline Product Risk
A borderline product is a product where it is unclear which regulatory framework applies. The same substance, the same formulation can land as a medical device, a medicinal product, a cosmetic, a food supplement, or a biocidal product depending on how the classification question is answered. And the consequences are significant: each framework brings different evidence requirements, different approval pathways, different timelines, and different cost structures. A product classified as a medical device follows MDR with Notified Body conformity assessment. The same product classified as a medicinal product follows Directive 2001/83/EC with a marketing authorisation from a competent authority. Getting the classification wrong, or choosing a classification that a competent authority later disagrees with, can mean starting the regulatory process from scratch. We have dedicated teams covering pharmaceutical, device, IVD, cosmetic, and food regulation, which means we can assess the full range of classification options and recommend the pathway that best fits the product, the evidence base, and the commercial strategy.
Common Classification Boundaries
Borderline disputes are not theoretical. They arise regularly in practice, and certain product categories generate them more frequently than others. Select a boundary to see the detail.
Medical Device vs. Medicinal Product
This is the most common borderline. The central question is whether the product achieves its principal intended action by pharmacological, immunological, or metabolic means. If it does, it is a medicinal product under Directive 2001/83/EC. If its primary mechanism is physical (mechanical action, physical barrier, lubrication, heat transfer, pH modification, hydration/dehydration), it can be a medical device under MDR.
The difficulty is that many products have mixed mechanisms. A wound dressing with antimicrobial properties: is the action pharmacological (drug) or ancillary to the physical barrier (device with ancillary substance under MDR Rule 14)? A nasal spray that works partly by physical barrier and partly through a pharmacologically active ingredient: where does the primary mechanism sit? A substance-based product for vaginal health, digestive health, or skin repair: is it acting through pharmacological means, or through physical or chemical mechanisms that do not qualify as pharmacological?
MDCG 2022-5 Rev.1 (updated October 2024) provides the EU framework for resolving these questions. But the guidance is principles-based, and reasonable experts can disagree on individual products. Some products (macrogol-based laxatives are the classic example) have different classifications in different EU Member States. The Helsinki Procedure exists to harmonise these decisions, and the MDCG Manual on Borderline and Classification (version 4, September 2025) continues to add new case decisions.
Medical Device vs. Cosmetic
Products intended for cleaning, protecting, or maintaining skin, teeth, or mucous membranes can fall under the Cosmetics Regulation (EC) No 1223/2009. But if the manufacturer claims a therapeutic or medical function (wound healing, treatment of a skin condition, protection against infection), the product enters MDR territory. The distinction often comes down to the claims on the label and in promotional materials.
A product marketed as "moisturising cream" is a cosmetic. The same formulation marketed as "treatment for atopic dermatitis" is a medical device or a medicinal product depending on the mechanism.
Medicinal Product vs Food Supplement
Products containing active substances (plant extracts, vitamins, minerals) presented as supporting a physiological function may be regulated as food supplements under Regulation (EC) No 1924/2006 (health claims) or as medicinal products if the manufacturer claims a specific medical purpose/indication. Here too, the intended purpose and the claims drive the classification.
Medical Device vs. Biocidal Product
Products intended for disinfection or sterilisation sit on the boundary between MDR and the Biocidal Products Regulation (EU) No 528/2012. MDCG 2022-5 Rev.1 clarifies that products with the sole intended purpose of cleaning, disinfecting, or sterilising medical devices are medical devices. Multi-purpose disinfectants fall under biocidal product regulation.
Annex XVI : No Medical Purpose
MDR introduced a new category: products that have no medical purpose but are similar to medical devices in function and risk profile. These are listed in MDR Annex XVI and include cosmetic contact lenses, dermal fillers, liposuction equipment, cosmetic lasers and IPL devices, brain stimulation equipment, and body contouring devices.
Common Specifications (CS) were adopted in December 2022 (Regulation (EU) 2022/2346), and MDR became applicable to these products from June 2023. Manufacturers of aesthetic devices previously unregulated or regulated only under cosmetics or general product safety law now face MDR conformity assessment including, for many product types, Notified Body involvement.
Why Classification Matters Commercially
The regulatory framework determines more than the approval pathway. It shapes the evidence you need to generate, the quality system you need to maintain, the post-market obligations you carry, and the claims you can make on the market. In some cases, one classification offers a faster or more cost-effective route to market. In others, the "easier" classification limits the commercial claims you can make, which reduces the product's market value. The easiest path is not always the best one.
Reclassification risk.
Switching a product's classification after it is on the market (device to drug, drug to device) is possible but involves significant regulatory and commercial effort. If a Notified Body questions the medical device status of a legacy product during MDR transition, the manufacturer may be forced into a reclassification process that was not planned or budgeted for.
Helsinki Procedure outcomes.
National competent authorities can refer borderline cases to the MDCG Borderline and Classification Working Group. The outcome is published in the Manual on Borderline and Classification. While not legally binding, these decisions carry weight and tend to be followed across Member States.
Substance-based devices.
For devices classified under MDR Rule 21 or devices with an ancillary medicinal substance under Rule 14, the evidence requirements are substantially higher than for conventional devices. Rule 14 devices are automatically Class III. Rule 21 devices require specific assessment of the substance's safety and interaction with the body. Manufacturers entering these categories should budget for correspondingly deeper technical documentation and clinical evaluation.
Example Projects
Illustrative Example
CE-marked as Class III medical device
Substance-Based Wound Care Product: Device vs. Drug
A manufacturer developed a wound care product containing a bioactive substance with antimicrobial properties. The classification as a medical device (Rule 14) or a medicinal product depended on the principal mode of action. We conducted the mode-of-action analysis, prepared the scientific justification for device classification, compiled the technical documentation including CTD for the ancillary antimicrobial substance, and managed the Notified Body submission as well as the consultation procedure with a Competent Authority.
CE-marked as Class III medical device
Illustrative Example
Reclassified, MA application submitted
Digestive Health Product: Reclassification from Device to Drug
A legacy product classified as a medical device under MDD was challenged during MDR transition, with the Notified Body requesting evidence that the primary mechanism of action was non-pharmacological. The scientific assessment concluded the product's primary action was pharmacological, triggering reclassification. We managed the transition, including the MA application under Directive 2001/83/EC.
Reclassified, MA application submitted
Not Sure Which Regulatory Framework Applies to Your Product?
Tell us about your product, its composition, intended use, and mechanism of action. We will assess the classification options and recommend the pathway that fits.
Speak with an ExpertFrequently Asked Questions (FAQ)
How do I know if my product is a medical device or a medicinal product?
The key criterion in the EU is the product's principal intended action. If it works primarily by pharmacological, immunological, or metabolic means, it is a medicinal product. If its primary mechanism is physical (mechanical, thermal, barrier, pH modification), it can be a medical device. MDCG 2022-5 Rev.1 provides the analytical framework. For products with mixed mechanisms, a detailed scientific assessment of the mode of action is required. We conduct these assessments regularly and can prepare the justification documentation for either classification.
What happens if a competent authority disagrees with my classification?
The authority can refer the product to the MDCG Borderline and Classification Working Group under the Helsinki Procedure. The outcome is a recommendation published in the Manual on Borderline and Classification. While not legally binding, these recommendations are widely followed. If the outcome contradicts the manufacturer's classification, the product may need to be reclassified, which can mean withdrawing from the market under one framework and restarting under another. This is why getting the classification confirmed before committing to a regulatory pathway is worth the investment.
What is MDR Rule 21?
Rule 21 applies to substance-based medical devices: products composed of substances or combinations of substances intended to be introduced into or applied onto the human body. These are classified as Class III (if absorbed systemically or act locally on the body), Class IIb (if applied to the skin), or Class IIa (if applied to mucous membranes or body orifices and not absorbed). Rule 21 was introduced with MDR and brings many products that were previously unregulated or lightly regulated into the device framework.
What are Annex XVI products?
Products without an intended medical purpose that are similar to medical devices in function and risk. Six categories: cosmetic contact lenses, surgical implants for aesthetic purposes, dermal fillers, liposuction equipment, cosmetic lasers/IPL, and brain stimulation equipment. Common Specifications apply since June 2023. Manufacturers must follow MDR conformity assessment, but no clinical benefit can be claimed; clinical evaluation focuses on performance and risk management.
Can I switch my product from a device classification to a drug, or vice versa?
Yes, but it is a significant regulatory and commercial undertaking. The evidence requirements, quality systems, post-market obligations, and approval pathways are different. A switch typically means withdrawing the product under the current framework and restarting under the new one. We have managed these transitions in both directions and can assess whether a switch is warranted and what it involves.