- marking

The medical device directive requires that all dental biomaterials must bear the CE marking of conformity when they are placed on the Nordic and European marked. The CE marking is based on an evaluation either of the product or of the production of the product. The directive does not require that the products shall comply with requirements in product standards. The quality criteria for the evaluation are set by the manufacturer, and the certification of the product is thus only a confirmation that the quality criteria of the manufacturer are met.

It seems that the majority of the manufacturers are choosing to certify their products on the basis of the production quality. The CE-marking of a product is thus no criteria for quality. It is up to you as a dentist, or dental health care authority, to make sure that the product has sufficient quality and clinical performance. This can be done by requesting additional information from the manufacturer regarding laboratory and clinical testing before you purchase a product.

The evaluation for the CE marking is done by the manufacturer himself (low risk products) or by a Notified Body (for all other products). NIOM undertakes testing for Nordic Dental Certification (NDC, formerly NIOM CERTIFICATION), a well recognised Notified Body for medical devices used in dentistry.