Is mandatory CE marking required for Oral Dental Brush Series and Polishing Brushes to enter the EU?

Currently, there are eight modes of using the CE marking recognized by the EU as follows:

(a) Factory self-control and certification.

Module A (internal production control):

1. Used for simple, high-volume, non-hazardous products, only applicable to the application of European standards for the production of manufacturers.

2. Self-conformity assessment and self-declaration by the factory.

3. The technical documentation is submitted to the national organization for ten years, on the basis of which the product can be evaluated and inspected to determine whether it complies with the directive, and the producer even has to provide the product's design, production and assembly process for inspection.

4. It is not necessary to declare that the production process always guarantees the conformity of the product.

Module Ab:

1. The manufacturer does not produce according to European standards.

2. Random testing of specific parts of the product by testing organizations.

(ii) Evaluation by a testing organization.

Module B (EC Type Approval):

The factory sends samples and technical documents to the testing organization of its choice for evaluation, and the testing organization issues a certificate.

Note: B alone is not sufficient for CE use.

Module C (Consistency with Type [Sample]) + B:

The factory makes a Declaration of Conformity (with the certified type), which is kept for ten years.

Module D (Quality Control of the Production Process) + B:

This model focuses on the production process and final product control, whereby the factory produces according to the methods approved by the testing organization (Quality System, EN29003), on the basis of which it declares that its product is consistent with the certified type (Declaration of Conformity).

Module E (Product Quality Control) + B:

This module focuses only on end-product control (EN29003), the rest is the same as Module D.

Module F (Product Testing) + B:

The factory ensures that its production process ensures that the product meets the requirements and then makes a declaration of conformity. An accredited testing organization verifies the conformance of its products through full inspection or sampling. The testing organization issues a certificate.

Module G (test-by-test):

The factory declares that it complies with the requirements of the Directive and submits the technical parameters of the product to the testing organization, which issues a certificate after checking the product one by one.

Module H (Integrated Quality Control):

This module focuses on the design, production process and final product control (EN29001). The rest is the same as Module D + Module E. Of these, Module F + B, and Module G are for products with particularly high risk.