Medical textiles in no man's land
Two years ago, the original Directive Medical Devices (93/42) has been revised. The earlier interpretation of this Directive (before the revision) was based on the principle of “primary intended use”. This means that in the event of a product having two functions, e.a. optical sun glasses, priority is given to one of both functions. The glasses from the example protect against sunrays (and is therefore a protection equipment) at the same time correcting the vision of the wearer (and is therefore also a medical device).
Other examples include surgeons’ jackets, medical masks, and gloves for medical applications. In these instances with double use, priority is generally given to the medical application, and therefore the product has only to comply with the requirements of the medical directive.
However, this is no longer so since the revision of the Medical Directive (new reference 2007/47). A product intended for double use, i.e. that is both a protection equipment and a medical device , has to comply with the requirements of both directives. From now on, a garment, protecting the surgeon against the patient’s germs and protecting the patient against the doctor’s bacteria, has to comply with the requirements of both the PPE and the Medical Device Directives.
Although the principle has been defined for two years, until now it was not clear how such products had to be certified. In a first interpretation of the European Commission, priority was given to the medical directive. If the product was in harmony with the medical directive, the producer only had to declare that it also complied with the PPE directive. This resulted into some unexpected and illogical situations, though!
Gloves, masks and surgeons’ garments are included in the medical directive where they come under the lowest category. This applies to non-sterile and non-implantable equipment that require no control by a notified body. In this way, a producer is able to market his products without having to submit it to a lot of control.
Totally different rules apply in the PPE directive. The products mentioned above come to categories in which a type control and in some cases even a yearly control are mandatory.
The difference between both directives allowed producers to by-pass the spirit of the law and to market protective equipment without any intervention by a notified body, simply by calling them ‘medical devices’.
An interpretative document recently issued by the European Commission rectifies this situation and obliges producers to follow the applicable certification procedures of both directives. Masks, gloves and medical clothing have to be submitted to a type control and, if applicable, an annual control.
Thanks to its engagement and experience in both fields, Centexbel is able to advise and assist you in introducing these products into the market.