The European Conformity Marking (CE) is the procedure by which a manufacturer (or importer) reports that the product to be marketed in the European Union meets the essential health and safety requirements defined in the mandatory legislation.

It is one of the basic pillars of the European Union for the free movement of goods, which helps to create an Internal Market favorable to development and wealth creation.

Consequences of this requirement:

The CE Marking represents an opportunity for companies, which can access all the markets of the European Union complying with the same rules that are required of them to sell in their place of origin.

CE Marking for Medical Devices:

Meaning of CE Marking

The Medical Device CE Marking located on a product, symbolizes and supposes a declaration that it complies with the Essential Requirements of the Directives that apply to it, and has followed the conformity assessment process required by them.

The manufacturer is responsible for carrying out the compliance process, sometimes a legal representative is appointed if the manufacturer is not in the EU.

It is recommended to start knowing the Medical Device CE Marking requirements that are established in the specific Directives for each product in the design, before starting to manufacture it.

In this way, the necessary requirements to comply with the applicable regulations can be included in the product design procedure, which will help reduce costs and time in obtaining a compliant product.

Documentation associated with CE Marking

The Medical Device Technical File as documentation to be prepared in each case will be defined in the application directive / s.

The Technical File, if applicable, constitutes an essential element for the conformity assessment procedures of a product, especially when an assessment procedure is applied in which a Notified Body does not intervene.

The declaration of conformity is a written document by means of which the manufacturer or his representative established in the European Union declares that the marketed product meets all the essential requirements of the different Application Directives.

Evaluation of the conformity of a product:

Once CE marking consultants has been verified that the product is affected by one or more Directives, the manufacturer must follow the procedure established in them to carry out product certification.

The objective of CE Certification Consultants for conformity assessment is to verify that the product complies with the Essential Requirements that affect it, record it documentary, and guarantee that this compliance will be maintained for all the same copies manufactured.

Two phases are always established for conformity assessment:

Design evaluation through the corresponding trials and studies.

Production evaluation through a certain production quality control, preferably based on ISO 9001 standards

In addition, each phase is divided into related modules, which are:

The Directives of application to each product are those that determine the types of modules that the manufacturer must follow to carry out the conformity assessment, some will modify these modules according to the product.

If you need help to know which directive applies to you or if you have an obligation to have the CE marking on your products, do not hesitate to contact CE Certification Consultants.