Medical Devices? Classification of Cosmetic and Aesthetic Products
At the time of writing this column, Fashion Week had just concluded in New York City. Without waxing philosophical about what constitutes style or beauty, as the author professes to possess neither, and claims no French heritage, it did make one ponder about a growing array of aesthetic products on the market today. For example:
• Is a product that is a machine used for aesthetic purposes a medical device? This aesthetic medical product does pose risk to the recipient - and potentially the user. Furthermore, the product contacts the human body and is invasive. However, it only purports aesthetic benefits.
• By the same token, what about a cosmetic product that is implanted into one's lip to increase the tissue mass of the lips to make the lips appear fuller?
Despite the fact that the acknowledged level of risk of using these products is similar to that for medical devices, the first product generally is not considered a medical device because an aesthetic purpose typically is not interpreted as medical. This machine, at best, is subject to the Electromagnetic Compatibility Directive EMC (and Low Voltage Directive, or LVD) in Europe. The second product is not regulated as a cosmetic product in Europe because it is implanted into the recipient, but once again, it also doesn't qualify as a medical device, either.
Quasi Medical Devices
The European Commission and member states generally are in agreement that medical devices must serve a specific medical purpose. And, not withstanding the definition of a medical device, the term "medical" can be variously interpreted. In the United States, for example, some of the aforementioned aesthetic products are regulated as medical devices. In Europe, however, different regulations may apply.
Medical devices are intended by the manufacturer "specifically for diagnostic and therapeutic purposes" (clarification per Directive 2007/47/EC) to do at least one of the following:
• Diagnose, prevent, monitor, treat or alleviate disease
• All of the above verbs, minus "prevent" but plus "compensate" an injury of handicap
• Investigate, replace or modify anatomy or physiological process
• Control conception
The European Commission recently questioned how certain products used for aesthetic purposes, given the moniker quasi medical devices, should be regulated when it posed its public questionnaire pertaining to the recast of the medical devices directives (for more information, see "Euro News" from the July/August issue of Medical Product Outsourcing, available at www.mpo-mag.com). Examples of this category of products, as cited by the Commission, include cosmetic lip implants, cosmetic wrinkle fillers, tattoo needles and equipment, implanted identification chips, contact lenses for cosmetic purposes and machines for aesthetic purposes. The Commission is only beginning to explore the regulatory possibilities for these products, and based on historical precedence, it is expected that this will require some time to decide the optimal regulatory classification. Note, the public will have an opportunity to provide opinions and contribute to the possible regulatory paths.
A History of Opinions
As might be expected, the European Union historically has garnered varying opinions about these borderline products. Tooth whitening products, for example, have been the subject of numerous discussions since the late 1990s as different member states debate whether these products are medical devices or cosmetic products. In fact, court cases related to tooth whitening products have been heard in several member states - such as the United Kingdom, Sweden and Germany - with mixed judicial decisions. For example, in the United Kingdom, the House of Lords ruled the products were cosmetics in a case pertaining to tooth whiteners, as the court concluded that these types of products did not possess a specific medical purpose. In addition, the Commission reminded member states in 2004 that tooth whitening products were to be classified as cosmetic products.
However, a feud still exists about how best to manage these products. There have been some attempts to classify tooth whitening products by stratification of product lines according to the concentration of hydrogen peroxide contained within the product - ie, less than 0.1%, 0.1%-6% and greater than 6%. Most of the member state Competent Authorities consider these products with less than 6% hydrogen peroxide as cosmetic products. As recently as this past June, Germany expressed a desire to classify tooth whitening products with greater than 6% hydrogen peroxide as medical devices.
Breast pumps are another example that falls into the classification conundrum. Manufacturers appear to classify breast pumps in various ways, either as medical devices or according to the EMC and LVD directives. As it turns out, the United Kingdom Competent Authority, Medicines and Healthcare products Regulatory Agency and the France Competent Authority, Afssaps, view breast pumps that are solely intended to collect milk from the mother for feeding to the baby as a general-purpose consumer good - and, thus, not with the purview of the medical devices directive. The caveat is that these products can be assigned a medical purpose if the product is used for a medical condition, such as to relieve the fullness of the mammary glands or to assist with mammary gland dysfunction.
With all the various opinions on this topic, the question facing European regulators is, how does the European Union reconcile the differences among the 27 member states, the three European Economic Area members (Norway, Iceland and Lichtenstein), as well as Switzerland?
Classification
Previous columns have alluded that classifying products as medical devices can be an exercise in dispute resolution. When one considers the various directives (and regulations) - along with the medicinal product, in-vitro diagnostic device, biocidal and/or cosmetic product - the combinations are endless.
The European Commission's Working Group on Borderline and Classification, composed of representatives of all member states, European Free Trade Association and other stakeholders, finally has published some of its consensus statements within a manual. This document, titled Manual on Borderline and Classification, was published as Version 1.0 and 1.1, and captures the consensus interpretation of certain borderline products. While the document is not legally binding, and a member state still has the prerogative to review products on a case-by-case basis, it does document the European view. The only legally binding views/decisions are those of the European Court of Justice, which is the only body that is an authority of community law.
Classification, New Procedures
The classifications of borderline products also will be relevant with regard to some upcoming regulatory actions. The modifications to the Medical Devices Directive MDD 93/42/EEC (Directive 2007/47/EC) will impact Article 13, the decision with regard to classification and derogation clause, as well as Article 7. When Directive 2007/47/EC is transposed into member state law/regulation and implemented (March 21, 2010), it will implement new member state conciliation procedures to assist with classifying these borderline products. The new procedure will permit member states to submit a duly substantiated request to the Commission if it is necessary to modify the application of the Annex IX, Classification Criteria rules with respect to the classification of a given device or if a category of devices or a given family of devices should be classified in another class (Article 13, MDD 93/42/EEC). And, Article 7 will ensure that these decisions are made by committee (European Commission and member states) and that the outcomes of the committee will be published by the Commission and legally binding - without the need to transpose a directive and without the guidance status.
A manufacturer must first decide the intended use of the product to ensure that it is a medical device. Some products will be borderline or quasi medical devices. The European Union has improved the mechanisms for publishing its consensus interpretations (as a manual) and also for resolving disputes through a committee whose results will be legally binding.
October 2008
