In the competitive race for innovation and marketing, a manufacturer may develop new technological products with the objective of using them for aesthetic applications. These may be cosmetics, or in some situations the product’s claims and other characteristics may be better suited under a medical device regulatory framework. For example, injectable dermal fillers with a medical claim may be regulated as medical devices whilst similar products making a cosmetic claim may not. In many cases, product claims can sometimes border between medical and cosmetic purposes, which represent a regulatory challenge to identify the distinction to prevent misleading claims and ensure risk-proportionate consumer safety.
Products positioned as a cosmetic when medical device positioning is more appropriate, may lead to inadequate regulatory compliance, such as lack of clinical evaluation by the manufacturer. In contrast, a product positioned as a medical device may be better suited as a cosmetic, which would avoid unnecessary or inappropriate requirements being placed on manufacturers. Medical devices are used for therapeutic purposes, while cosmetic products should only focus on appearance enhancing (see Table 1 for definitions of a medical device and a cosmetic product in EU and US).
Regulations are in place to ensure relevant safety and effectiveness requirements are tailored to the qualification of the product and maintain consumer safety. For example, in the EU a medical device needs certification for a quality management system whilst a cosmetic product needs to follow compliance with good manufacturing practice. Other positive benefits of determining qualification early on in the development allows manufacturers to:
- invest only on those activities that are appropriate for product development;
- de-risk qualification challenges from certification bodies;
- engage and build trust with regulators; and of course,
- maintain good reputation in front of consumers.
In this two-part article, we explore how EU and US regulatory approaches address this gray area of cosmetic/medical device borderline product claims and guide manufacturers on compliance with the appropriate regulatory framework.
Definitions of a medical device and a cosmetic product in the EU and US Regulations
EU |
|
Medical device |
Cosmetic product |
Medical Devices Regulation (MDR) EU 2017/745 – Article 2Any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes: •diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease, •diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability, •investigation, replacement or modification of the anatomy or of a physiological or pathological process or state, •providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations, and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means. The following products shall also be deemed to be medical devices : •devices for the control or support of conception. •products specifically intended for the cleaning, disinfection or sterilisation of devices as referred to in Article 1(4) and of those referred to in the first paragraph of this point. |
REGULATION (EC) No 1223/2009 on cosmetic products – Article 2(a) ‘cosmetic product’ means any substance or mixture intended to be placed in contact with the external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours; |
US |
|
Medical device |
Cosmetic product |
FD&C Act (21 USC 321(h))An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is (A) recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them, (B) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or (C) intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes. |
FD&C Act (21 USC 321(i))The term «cosmetic» means (1) articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and (2) articles intended for use as a component of any such articles; except that such term shall not include soap. |
Table 1 Definitions of a medical device and a cosmetic product in EU and US
EU and US Regulations for medical devices and cosmetic products
In the EU, regulations of medical devices and cosmetic products fall under the Medical Devices Regulation 2017/745 (MDR) and the Cosmetic Products Regulation No 1223/2009 (CPR), respectively. These are mutually exclusive regulations and Article 1 of the EU MDR specifically states that this Regulation does not apply to cosmetic products covered by CPR No 1223/2009. In the US, medical devices and cosmetics are regulated under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The Food and Drug Administration (FDA) is the regulatory authority responsible for the implementing the regulation for these both type of products. The key features of the frameworks applying to medical devices and cosmetic products and in the EU and in the US are described in Table 2.
Medical devices vs. Cosmetics Products |
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EU |
US |
|
| Regulators | EU Commission, Competent Authorities implementing the individual regulations (medical devices and cosmetic products), but also involvement of third-party certification Notified Bodies* for medical devices. | Food & Drug Administration (FDA) is the authority in charge of both medical devices and cosmetic products. Product expertise is split in different review centers (Center for Devices and Radiological Health (CDRH) for medical devices; and Center for Food Safety and Applied Nutrition (CFSAN) Office of Cosmetics and Colors for cosmetic products). |
| Main Regulations | Dedicated Regulations for each type of product: MDR 2017/745 (medical devices); CPR No 1223/2009 (cosmetic products) | Both covered by the same key Act: Food, Drug, and Cosmetic Act (FD&C Act). (Cosmetic products are also regulated under the Fair Packaging and Labelling Act FPLA but this is outside of blogpost scope). |
| Classification | Yes, for medical devices and based on risk (which guides regulatory requirements). | |
| Pre-market notification | Certification system for medical devices (with Notified Body involvement based on risk classification) and cosmetic products only need notification to competent authority. | FDA notified for clearance/approval (subject to class) for medical devices, but not for cosmetic products. |
| Evidence of safety | Yes, for both, but medical devices also need a clinical evaluation (since they are used for therapeutic purposes). | Yes, for both and high-risk medical devices also need clinical data (since they are used for therapeutic purposes). |
| Post-market activities | Medical devices need to be monitored and reported to competent authorities by manufacturers for adverse events. It is mandatory for manufacturers to report serious undesirable effects to the competent authority.
Both medical devices and cosmetic products may come under action taken by respective competent authorities if needed. |
Medical device manufacturers must report reportable adverse events to the FDA. But it is not mandatory for manufacturers of cosmetic products to report problems to the FDA.
The FDA also monitors and may issue warnings or take other actions for both medical devices and cosmetic products. |
| Registration | European Database on Medical Devices (EUDAMED) includes restricted and public access features (Medical Devices – EUDAMED (europa.eu)).
For cosmetic products, European Commission needs to be notified prior to placing on the market (Cosmetic product notification portal (europa.eu)). * (see blog post: Selection of a Notified Body for Medical Device Development) |
Mandatory with FDA for medical devices (How to Register and List | FDA).
Previously, the FDA encouraged their Voluntary Cosmetic Registration Program (VCRP) for cosmetic products, but this is now ceased and plans are underway for a new system. |
Table 2 Key features for medical device and cosmetic product regulations in the EU and US
Medical device manufacturers need to note that in the EU, certification is carried out by an organization independent to the regulator, whilst in the US, all of the regulatory activities are conducted within the same the organization i.e. the FDA. Therefore, manufacturers seeking engagement or contractual agreement need to ensure they contact the relevant stakeholders and consider timelines for specific activities along the product development plan to avoid wasting time and resources.
They should also note that at first glance, the definition of cosmetic products appears similar between EU and US, but the US allows cosmetics to be introduced into the human body (cosmetics are externally applied in EU) whilst specifying it does not affect body structure or functions. Details which seem little may have a big impact on manufacturer’s regulatory strategy, if not followed to the rule. The differences in qualification or geographical jurisdiction dictate which stakeholder to contact for specific activities, add clinical elements in the pre-market stage or set up a vigilance system, amongst several other key considerations. It is important to know your product to identify the most suitable regulatory framework and to establish a sound development and market strategy.
Great Britain regulatory framework
Since the exit of the UK from the EU (1 January 2021), new legislative requirements have been placed in the UK separate to the EU regulatory requirements applicable to the other EU Member States. Specifically, Great Britain (GB – England, Scotland and Wales) currently allows the marketing of medical devices in the GB (different rules apply in Northern Ireland) if they comply with the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002) or the EU Regulation. These provisions will be gradually transitioned out once the UK Government drafts and publishes its future medical device regulations for the UK market.
In relation to cosmetic products, for the moment GB still operates under Regulation (EC) No 1223/2009 on Cosmetic Products, as amended by the Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019. The Regulation sets out requirements that must be met before cosmetics products can be placed on the GB market.
However, the scope of this blogpost focuses on EU and US and a comparison between the GB and other geographical legislations would require a separate analysis of its own. But manufacturers should keep in mind the same requirements may not apply anymore for GB and EU when planning their regulatory strategy for the two markets.
In this part 1 of blog post, we visit the scope of products of the different regulatory areas for the two geographical jurisdictions and how they are regulated in each case. In the upcoming part 2, we will explore the extent of the ‘claims’ that can be made on aesthetic products whether they are developed as cosmetic or medical device. We will illustrate these nuances through a dedicated case study.
References:
- REGULATION (EU) 2017/ 745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL – of 5 April 2017 – on medical devices, amending Directive 2001/ 83/ EC, Regulation (EC) No 178/ 2002 and Regulation (EC) No 1223/ 2009 and repealing Council Directives 90/ 385/ EEC and 93/ 42/ EEC (europa.eu)
- FOOD AND DRUGS (house.gov)
- Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (europa.eu)
- FDA Authority Over Cosmetics: How Cosmetics Are Not FDA-Approved, but Are FDA-Regulated | FDA
- How to Register and List | FDA
- Cosmetic product notification portal (europa.eu)
- Mandatory Reporting Requirements: Manufacturers, Importers and Device User Facilities | FDA
Published on: September 6, 2023
