All marketed products that are sold in the European countries must usually have the CE certified marking. It is considered as an essential requirement in Europe and all products must have necessary CE marking.
In most of the cases, it is a regulation that this CE marking must be present on the packaging and containers to show the various users that the concerned health product is following the essential criteria of security. Nevertheless, not every product needs to include it.
Generally, those products that are having CE marks will be regulated under the directives of European standards, so that all products/materials and instruments which are risky for the health of users can be safer.
Usually, this CV protection will commercialize only with 2 categories of products that are listed as:
- Personal Protective Equipment
They will be regulated by European Directive 89/686/CEE, which is transposed by royal decree 1407/1992. CE certified masks, gloves and protection clothes comes under this category of products.
- Medical Devices
They will be regulated by directive 93/42/CEE, which is transposed by royal decree 1591/2009. In this category too, globes are also found again and determined by disposable clothes like surgical masks and white coats.
Therefore, we can see, Gloves are appearing in both categories, and hence they are considered as dual products, that must obey both the requirements.
As per compliance proof of CE marking requirements, a declaration is needed for both directives to sign and write a declaration, Approval CE Declaration, that proves before the buyer about compliance of the products regulations.
This kind of declaration is sufficient in the European country’s documentation for commercialization in accordance with basic products, which is included in EPI’s 1st Category and PS 1st Type.
Those products that are classified in second and third types of PS and also second and third categories in EPI, like chemical/biological protection Gloves should be certificated by Notified Organization.
This certificate must always be preserved as product documentation’s important part. Also, the identification number provided by the Notified Organization must always be printed on product packaging as per the CE marking.
All products need not obey all these requirements and, few of them may often create confusion because of their apparent purpose. Usually this can be the case of majority of fabric/non- fabric/plastic disposable clothes, like coats, overalls, aprons, breeches etc.
This can also happen with few other items like cellulose products e.g. hand dryer coils and towels and re-closable bags/trays among others.
All these items will not be included in both the categories previously described and in other directives that regulate CE marking. They must not have CE marking as a result. Since they are usually health items, hence in most cases can prevent the user to get dirty.
To sum up, we can say that before purchasing or commercializing any CE marketed products, it is necessary to get information regarding their category for checking if they can be regulated by any Directives.
In case, they are possible then, we must ensure whether they will obey all established requirements and also ask the supplier to provide appropriate documentation for each case.