CERTIFICATES ISSUED BY CELAB
In order to support the importers of protective masks, we have written this generic guide about the different types of masks currently available.
We are going to use a non-technical terminology on purpose, in order to make everything clear to non-technician users.
There are 2 types of protective mask:
- Masks meant to protect ourself,
Called DPI (Individual Protection Devices). They are ruled by the European Regulation about personal security devices. This regulation REQUIRES the sign of a notified body, specifically authorized for this purpose. CELAB is NOT A NOTIFIED BODY for Individual Protection Devices. Without the approval of a notified body, the device CANNOT ENTER THE MARKET IN EUROPE, nor in Italy of course. Before importing, the provider must ensure that the product has been approved by a notified body and that the technical documentation is properly filled.
- Masks meant to protect others.
This type of mask (the surgeon type, for example) is meant to support other’s safety, therefore it is included in the medical device regulation. This type of device (Class I) does not require the sign of a notified body (CELAB IS NOT A NOTIFIED BODY FOR MEDICAL DEVICES). In order to import these masks, though, they still must have a CE marking.
For both types, the producer must comply to the appropriate regulation, using a notified body if necessary (NOT CELAB, we DO NOT provide this type of authorization), and sing the compliancy agreement.
Who is the manufacturer?
Warning: the manufacturer is NOT the company who make the product. The manufacturer is the company who puts its name on the product. So, if you are importing a product, and you are going to put your company name on it, your company is considered to be the manufacturer according to the regulation.
The certifications issued by CELAB for these types of products CANNOT BE USED TO IMPORT THE PRODUCTS, AS CELAB IS NOT A NOTIFIED BODY IN THIS FIELD.
As stated on our certificates, BEFORE USING THE CERTIFICATION it is compulsory to read and accept the regulation that comes with it, in order to understand the proper and allowed usage of it.
Therefore, on the second page of the certificate itself you will find a detailed description of its purposes. If the certificate does not have a page 2, then it should be considered FALSE.
Once again, we underline that YOU CANNOT USE these certification as a proof of a CE marking. Also these certifications CANNOT be shown to the custom borders as a proof of certification.
The aim of these certificates is to clarify, in a contractual phase with the provider, that some of the steps needed to obtain the CE marking have already been completed and that they have been successfully checked by CELAB. Those steps are detailed on the certificate.
WARNING: this check has NO LEGAL VALUE but just a commercial importance and by NO MEANS it implies that CELAB takes any responsibility on the product. This check means that Celab reviewed some technical documentation and found them correct and complete ACCORDING TO CELAB JUDGJMENT.
It is the importer responsibility to verify that all the actions on the product required by the regulation have been properly taken.
CELAB services in this field
In case your company does not have internal knowledge to do this, CELAB is at your service to check the documentation, verifying if the technical documentation is complete, if all the actions required by the regulation have been taken and so forth…
This service includes any other request about how to behave (what is stated by the regulation, the rules to be indicated on the product, or any other technical interpretation).
- DOES NOT include activities run by a notified body
- IT IS NOT REQUIRED BY LAW
- IT IS NOT a certification service for products
It is indeed very useful if you do not have any internal knowledge of the subject and you want to know the actual situation with your producer.
CELAB services are meant for companies exclusively