EC 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 EC marking of medical devices for their marketing. This EC 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 disease,
- diagnosis, prevention, monitoring, treatment or alleviation of or compensation for an injury or handicap
- investigation, replacement or modification of the anatomy or 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."
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 :
- the duration of use
- whether or not the device is invasive and the type of invasivity
- whether or not the device may be reused
- the therapeutic or diagnostic aim
- whether of not the device is active (dependent on a source of energy)
- the part of the body in contact with the medical device.
One can consider that the level of the classes is principally based on the risk which the medical device presents for the user. Thus a class III medical device will have to conform to more rules to prove its effectiveness and harmlessness than a IIb device, which will follow even more rules than a class IIa medical device, etc.
If several rules of classification can apply to a medical device, it will then be classified in the highest class.
Classification of medical devices according to the directive 93/42/CEE
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 DIPHOTERINE®, HEXAFLUORINE® and AFTERWASHII® 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 AFTERWASHII® 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’s 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 AFTERWASHII® 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.
Table 1 : classification criteria of Prevor washing solutions according to the European directive 93/42/CEE..
|Rules of classification||Historically||Today|
|What is the duration of use?||the duration of use is temporary because DIPHOTERINE®, >HEXAFLUORINE® and AFTERWASHII® solutions are intended for continuous use for less than 60 minutes.|
|Is this an active medical device?||no, because the DIPHOTERINE®, HEXAFLUORINE® and AFTERWASHII® solutions do not depend on a source of energy.|
|Is the solution a surgically invasive device?||no, because Prevor’s solutions are not intended in whole or in part to penetrate inside the body.||yes, because DIPHOTERINE®, HEXAFLUORINE® and AFTERWASHII® solutions can penetrate inside the human body by another way than an existing opening of the body, in the case of an application on injured eyes or skin.|
Conclusion : The utility of the classification
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’s 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.