CE Marking and classification of medical devices

In 1985, the member States of the European Economic Community established an area without internal frontiers in which free movement of goods, persons, services and capital were ensured. That implied the harmonisation of the regulations in force for each field. Thus, the directive 93/42/CEE relating to medical devices was adopted in 1993. It guarantees that medical devices should provide patients as well as users “a high level of protection and attain the performance levels attributed to them by the manufacturer.”

This directive imposes CE marking of medical devices for their marketing. This CE marking means that the medical device is in conformity with the “Essential Requirements” defined by the directive, and which are in fact the technical conditions which the medical devices must satisfy in order to be placed on the market. Their respect ensures both quality and reproducible safety for the user.

The directive 93/42/CEE defines as medical devices: “any instrument, apparatus, appliance, material or other article whether used alone or in combination, including the software necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:

• diagnosis, prevention, monitoring, treatment or alleviation of a disease,
• diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
• investigation, replacement or modification of the anatomy or of a physiological process,
• control of conception, and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means.” whether the device depends on a source of energy, mais dont la fonction peut être assistée par de tels moyens. »

The medical devices thus defined are divided into four classes : I, IIa, IIb and III. The rules of classification defined by the European directive are based on:

• duration of use
• whether the device is invasive or non-invasive, and the type of invasiveness
• whether the device is intended for single use or reusable
• whether the intended purpose is therapeutic or diagnostic
• whether the device depends on a source of energy
• the part of the body that comes into contact with the medical device

In a simplified and somewhat reductive way, the classification level can be considered to be essentially based on the risk the medical device may pose to the user. Accordingly, a Class III medical device must comply with more stringent requirements to demonstrate its safety and performance than a Class IIb device, which in turn must meet more requirements than a Class IIa device, and so on.

If several rules of classification can apply to a medical device, it will then be classified in the highest class.

To be able to define the class of our washing solutions, certain questions, presented in table 1, had to be answered for each one of our washing solutions.
The answers initially led us to classify our solutions in class I, sterile ; then following the interest and the increasing use of the DIPHOTÉRINE®, HEXAFLUORINE® solution and AFTERWASH II® en Europe, nous avons été amené, à la demande de la Communauté européenne, à classer nos produits dans la classe supérieure : IIa., stérile.

The answers initially led us to classify our solutions in class I, sterile ; then following the interest and the increasing use of the DIPHOTERINE®, HEXAFLUORINE® and AFTERWASH II® solutions in Europe, we were led at the request of the European Community to classify our products in the higher class: IIa, sterile.

This change of classification had neither an impact on the manufacture of, nor on the formula of the DIPHOTERINE®, HEXAFLUORINE® and AFTERWASH II® solutions. The difference in classification resides, in the case of our solutions, in our claims for the medical device: Prevor solutions can be applied even to injured surfaces (skin or eye), contrary to class I solutions which can only be applied to healthy surfaces.

Indeed, Prevor solutions are intended to be used in emergency situations following chemical splashes and their application protocol, which defines a duration and the quantity of washing solution, makes it possible to avoid the appearance of burns thanks to their physicochemical properties. In an emergency situation where fear and pain are involved, the user is not necessarily able to consider whether the skin or eye is healthy or not. Tests carried out on the DIPHOTERINE®, HEXAFLUORINE® and AFTERWASH II® solutions have proved their harmlessness when applied to both healthy and injured surfaces. Thus, in the event of a chemical splash, the user will be able to apply a PREVOR solution without having to wonder whether the concerned surface area is healthy or injured, thus avoiding a waste of time in the handling and treatment of the splash.

According to the class of the medical device, the evaluation of conformity to the requirements of the directive 93/42/EE will be carried out according to different procedures. It should be noted that in the case of a medical device placed on the market in a sterile condition, as is the case with Prevor solutions, the manufacturer’s quality system must imperatively be audited by a notified body and more specifically on those aspects of the manufacturing process designed to secure and maintain sterility.

The manufacturer may then affix the CE marking on these medical devices, and the user is then ensured to have at his or her disposal medical devices which are in conformity with the requirements of the directive 93/42/CEE.