CE-Marking for medical devices


When is the product a medical device?
A product is seen as a medical device when:

“Medical devices are products or agents which are used for medical purposes, with the exception of drugs for medical purposes.”

A medical device needs to have a CE-Marking. In the case of Cobeco, some of our products are seen  as “medical devices” which means they need a CE-Marking. 

The CE mark is a conformity regulation that must be applied to products that are covered by the European New Approach Directives. With this marking the manufacturer shows that the product complies with the requirements as described in the applicable Directive(s).
All products bearing the CE marking have free access to the entire market within the European Economic Area. Products that are not in compliance with the directives and do not bear the CE marking, are not permitted to be traded or put into use within the European Economic Area.

The products of Cobeco that are offered with CE marking

Class I Lubricants
Cobeco Pharma registers their lubricants as a Medical device class I. Because a condom is a medical device, the lubricant to be used with the condom can be classified as a medical device. Next to this a lubricant is also seen as a Medical device class I when the purpose of the lubricant is that the lubricant gives aid with sexual intercourse, to have less dryness.  It is possible to have a private label lubricant with your name on the label.

Class II Lubricants
At the moment, Cobeco Pharma is in the process of registration of the lubricants as Class II lubricants. We expect to be able to offer you Class II lubricants as a private label at the end of this year, 2013.

Class II Condoms
Cobeco Pharma Pharmcon classifies their condoms as a Medical device class II. Class II products have stricter rules than Class I products, therefore a more extensive procedure (the CE class II procedure) is necessary. It is possible to have your private label condoms with your name on it  as a distributor but the name of Cobeco Pharma Pharmcon always has to be on the label as manufacturer.

How does Cobeco Pharma notify the products?

Class I Lubricants
Cobeco Pharma registers the products on the portal of the Dutch Ministry of Health. To register the products a technical file is needed. This file holds all the information relating to the product. Cobeco Pharma has a complete technical file of her lubricants. After the registration is completed, you will receive a letter from the Dutch ministry of Health that your lubricant is registered as a Class I lubricant.

Class II Lubricants
Cobeco Pharma registers the products at a notified body after which you will receive a declaration of conformity regarding the lubricants.

Class II Condoms
Cobeco Pharma Pharmcon registers the condoms at a notified body after which you will receive a declaration of conformity regarding the condoms.

Who is responsible for the files?
Cobeco Pharma has the product files at the company. The procedure for CE marking files, by law, must be available at the location of the manufacturer. When authorities have questions they can contact the local ministry of Health in the Netherland’s