Cosmetic or Medical Device for Compromised Skin? Why an Early Clinico-Regulatory Strategic Analysis Makes the Difference

By Sandra Dejean, PharmD – Founder of One Health Compliance
Article based on a presentation delivered at the 29th European Dermocosmetology Days (February 2019)

Introduction

In February 2019, I spoke at the European Dermocosmetology Days to address a question that is structurally important for the sector: should a product intended for compromised skin be developed as a cosmetic or as a medical device? [1]

This subject, raised seven years ago, remains fully relevant today. It arises particularly in the context of R&D, but also in light of field feedback: a product initially developed as a cosmetic may reveal new properties, or demonstrate a capacity to treat or prevent a skin condition. These discoveries — often emerging from clinical experience or user feedback — open repositioning questions that deserve to be explored with method.

This article builds on the analysis presented at that event, enriched by experience gained since in supporting companies facing this question, either ahead of development or when evolving their product range.

Regulatory status: a decision that shapes everything

Choosing a product’s regulatory status is a strategic decision that determines product design, permitted claims, the data to be generated, the regulatory dossier to be built and ultimately, the product’s place in therapeutic and commercial strategy.

In practice, this question is sometimes underexplored: some teams perceive medical device status as complex or unfamiliar, while others start from an initial marketing positioning that does not naturally open onto other regulatory options. Yet exploring these options early — before formulation, design or communication choices are finalised — is a genuine source of value: it makes it possible to confirm or refine strategy on solid grounds, and to identify possibilities that had not previously been considered.

Cosmetic vs medical device: two approaches, two claim spaces

A cosmetic product can claim actions such as cleansing, perfuming, changing appearance, correcting body odours or maintaining them in good condition [2]. It can be recommended by healthcare professionals, particularly in the context of dermocosmetology, and its place in care protocols is recognised.

A medical device can go further in its claims: acting on a physiological or pathological process, treating a wound or a dermatological condition, contributing to the prevention or investigation of a condition [3]. This is not to say that a medical device is “more” than a cosmetic. It is that it serves different objectives, with medical claims that a cosmetic cannot make.

This is where the opportunity lies: for a product whose action is part of managing a skin condition — atopic skin, irradiated skin, wound healing, chronic wounds — the medical device status can open clinical claims that strengthen the product’s credibility with prescribers and patients, and position it differently in the therapeutic landscape.

Medical device: a different approach, specific requirements

Opting for medical device status means committing to a process of demonstrating clinical benefit which represents a strong competitive positioning in a context where healthcare professionals’ expectations (and patients’!) regarding evidence are growing.

This process implies a different approach from that of a cosmetic: a regulatory strategy defined upstream, product design aligned with safety and performance requirements, and a regulatory technical documentation integrating preclinical and clinical data. It may require a longer time to market but this time is in service of a more robust positioning and more differentiating claims.

It is important to note that medical device status is not systematically the best option. Everything depends on the state of the art in the relevant condition, unmet needs, products already available on the market, and the company’s strategic objectives. In some contexts, cosmetic positioning remains the most appropriate and this is this analysis that makes it possible to confirm or challenge.

Addressing these questions early is a way of investing intelligently: it enables resources to be prioritised, certainty about development choices to be strengthened, and a base of future possibilities to be built rather than discovering constraints mid-development that could have been integrated from the outset.

The mechanism of action question: at the heart of strategic thinking

The boundary between cosmetic and medical device rests on one key concept: the primary mechanism of action. A product whose primary action is mechanical or physical may potentially qualify as a medical device. For skin care products, this boundary is often complex to establish: an active ingredient that interacts with the skin barrier, creates a protective film or modifies a physiological process may fall under one status or another — or a third, such as a medicinal product or biocide.

This is a consideration that affects all aspects of regulatory framework. It touches on the clinical, scientific and technical positioning of the product: which condition is being targeted? What are the unmet needs? What proof of efficacy do healthcare professionals expect? What is the product’s place in the existing therapeutic landscape?

Conducting a technico-regulatory brainstorming session, or even an initial strategic clinico-regulatory analysis upstream, makes it possible to invest in a targeted way: strengthening certainty about positioning, building a base of scenarios and future possibilities, and prioritising resources in line with strategic objectives and market realities.

What an initial analysis makes possible

Investing in an upfront strategic analysis means answering several fundamental questions before committing resources:

• What is your product’s mechanism of action and what status does this imply?
• What claims do you want to make, and which are accessible under each status and given the state of the art?
• What are the implications for your design and the data to be generated?
• What initial clinical investigation scenarios are feasible to confirm positioning and open future possibilities?
• What is the impact on your timeline and resources under each option?
• What role do you want your product to play in patient management given unmet needs and products already available on the market?

These questions are as much strategic as regulatory. They determine the relevance and sustainability of a positioning.

Conclusion

The question “cosmetic or medical device?” has no universal answer. It depends on the product, its mechanism of action, the intended claims, the state of the art in the relevant condition, unmet needs and the company’s strategy. What is certain, however, is that this question benefits from being asked early and in a structured way, before development choices close certain doors.

A One Health Compliance Technical Day is designed to address this question in one day, with your team: identifying the most appropriate positioning given your product and target market, analysing regulatory, clinical and technical implications, mapping possible initial investigation scenarios, and providing decision elements to move forward with clarity.

→ Are you developing a product for compromised skin or considering evolving your range? Let’s talk for 15 minutes.

References

[1] Dejean S. Medical device instead of cosmetic product for compromised skin? Design approach and impact on the regulatory file. 29th European Dermocosmetology Days, Lyon, February 2019. Available at: https://www.cosmetinlyon.com/actualite/31-janvier-1er-fevrier-2019-xxixemes-journees-europeennes-de-dermocosmetologie/

[2] Regulation (EC) No 1223/2009 on cosmetic products. Available at: http://data.europa.eu/eli/reg/2009/1223/oj

[3] Regulation (EU) 2017/745 on medical devices (MDR). Available at: http://data.europa.eu/eli/reg/2017/745/oj.

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