Official Communication on document “certificate of Compliance”

Following the several reports of improper and fraudulent use of our documentation and our Notified Body number 1282 and aware that the current emergency situation may generate confusion and concerns, we would like to provide some clarifications.

With reference to personal protective equipment, we would like to clarify that we are NOT a Notified Body for PPE at this moment and therefore we cannot and do not issue any CE certification for this directive. The documents in circulation “Certificate of Compliance” are NOT CE certificates, as clearly indicated in the contents of the document, which must be read carefully and completely, in order to avoid misinterpretation or improper use.
The conditions for the issue of the document specify that the manufacturer is responsible for the CE certification of the product and is required to carry out all necessary conformity activities before placing the product on the market, as also stated in the “Remark” paragraph of the document.
Any activity performed in relation to the PPE Directive is a voluntary review of the technical documentation and can in no way replace the CE certification. This voluntary certificate is the first step of the manufacturer towards conformity and serves as a guideline for manufacturers who want a first opinion on the documentation they produce.
We would like to underline that manufacturers and their consultants who have requested this service are aware of the voluntary nature of this type of verification, as they have signed the terms and conditions of the service, according to our Voluntary Mark Regulation, published on our website and available for free consultation at https://www.entecerma.it/en/customer-area/official-documents/.

Unfortunately, taking advantage of the emergency situation, many manufacturers make a deliberate improper and fraudulent use of these documents, trying to pass them off as CE certificates. Therefore, we are implementing an information campaign to intercept and stop this kind of activity, trying to do our best to make sure that only real certificates are circulating and that the products are not put on the market without the appropriate certifications.

We encourage anyone who knows about fake certificates or misuse of our notification number to notify us at info@entecerma.it | info@ecmmedicaldevices.com, so that we can immediately inform the competent authorities.