Some of the companies from the cosmetic industry that have moved to the field of medical devices and/or some other companies with a huge experience in the latter industry, have in their portfolio of medical devices the so-called “substance-based products”, i.e, medical devices in the form of cream, gel, ointment, solutions, etc. based on the formulation of one or several components.
In many cases, when we speak of substance-based medical devices, we are referring to products intended by the manufacturer to be used on intact skin, or invasive products through a body orifice (nasal, optic, vaginal products, etc.) with a limited contact time, i.e products that, according to the classification rules of Directive 93/42/EEC (MDD), the manufacturer placed them on the market as Class I medical devices.
Although Class I products must meet the same essential safety and performance requirements as those of higher risk (IIa, IIb and III) and, theoretically, must have a complete technical dossier in accordance with the requirements of the MDD, these were products that did not require the intervention of a notified body to be placed on the market, being just the manufacturer responsible for issuing a declaration of conformity, self-certifying the compliance with those requirements.
Though, a little bit more than a year for the date of the application of the new Medical Devices Regulation 2017/745 (MDR) which replaced the current Directive 93/42/CEE (MDD), this ” comfortable ” situation for the manufacturers of substance-based product will change substantially, since, among the new classification rules introduced by the new regulation, is the famous Rule 21, according to which, devices that are composed of substances or of combinations of substances that are intended to be introduced into the human body via a body orifice or applied to the skin and that are absorbed by or locally dispersed in the human body are classified class IIa f they are applied to the skin or if they are applied in the nasal or oral cavity as far as the pharynx, and achieve their intended purpose on those cavities or class IIb in all other cases.
This means that, from next May 26th, 2020, substance-based medical devices can no longer be classified as Class I. Wetting agents, nasal and throat sprays or ear drops currently on the market as devices Class I will now face a procedure for assessing the compliance and the participation of a notified body in order to audit aspects related to the product and the manufacturer’s quality management system. Even invasive devices currently classified as Class IIa will increase their class of risks and will be classified according to Class IIb (for example, vaginal gels).
Although, as above mentioned, according to the MDD, Class I products should also have a complete technical dossier and the manufacturer should comply with the guarantees of a quality system according to ISO 13485, since this documentation or quality management system was not evaluated by an independent agent such as the notified bodies, these products did not always offer adequate guarantees of safety and performance, or if they did, compliance was made according to the manufacturer’s interpretation.
Therefore, all medical devices on substances-based must meet stricter essential requirements that, in some cases, will be similar to the requirements for medicines. For example, currently under the MDD, most clinical evaluations of class I products, if any, are based on a study of the individual properties of each of the components of the formulation or in comparison with other equivalent medical devices. However, for class IIa or IIb products according to the MDR, such equivalence must be validated by a notified body and in any case, the clinical evaluation must be carried out in accordance with the MEDDEV 2.7 / 1 rev 4 guides.
Given this perspective, many manufacturers may think that, since the MDR states that products with CE marking under the MDD can still be marketed up to four years after the date of application of the MDR, that is, until 2024, they still have time to adapt their dossiers and undergo an evaluation procedure by a notified body. However, this is a misconception, since this qualification refers to products with a CE certificate by a Notified Body, while for Class I products, as of May 2020, the classification rules of MDR will be applied, becoming class IIa or IIb products. Consequently, if they remain in the market as class I, they would be in an irregular situation.
Moreover, this is not entirely true, even for those products on substances-based that, due to their characteristics (contact with damaged skin, invasive through a prolonged contact time hole, etc.) already have a CE certificate from a notified body under the MDD or who have just obtained it and believe that they are safe until 2024, since according to the transitory provisions of Article 120, paragraph 3 of the MDR “The requirements of this Regulation relating to post-market surveillance, market surveillance, vigilance, registration of economic operators and of devices shall apply in place of the corresponding requirements in those Directives“. Therefore, since May 26th 2020, all of the aforementioned needs must be met for the MDR, having a current certificate according to the MDD or not.
For manufacturers of substance-based devices, meeting these new requirements adds to the efforts needed to provide stronger clinical evidence to support the safety and performance of their devices. Keeping in mind that the clock does not stop and that the MDR application date is fast approaching, particularly for manufacturers of Class I products that cannot be marketed after May 26th 2020, it is time to make decisions and act quickly.
The requirements demanded by a notified body will always be much more demanding than those of the own manufacturer, therefore, from ZURKO Research we can help these manufacturers to keep these products in the market according to the new legislation, supporting the adaptation of the technical dossiers of the products to the requirements of the MDR, carrying out the preclinical tests and necessary clinical investigations, as well as guiding the manufacturer in the implementation of a quality management system according to ISO 13458.
Juan Ángel Gracia García
Technical Director Medical Devices Dpt. Zurko Research