"CE" is an abbreviation of "Conformité Européenne" (French for "European Conformity") and it is used by manufacturers to indicate that the product complies with EU directives and the relevant European standards specified in the instructions and guidelines.
On the road to the European market, the CE mark is an important and mandatory element of your product. The free flow of goods is the basis of the European Union's internal market. The purpose of free movement of goods is to prevent new restrictions on trade and ensure mutual recognition and technical harmonization. The CE marking allows free movement of goods on the EU market and for this reason, the CE mark is also called "passport, or ticket for the European market".
The CE mark on the product is a mark of the manufacturer that the product meets all the essential safety and health requirements in relation to the EU guidelines and harmonized standards. The EU guidelines for implementation of directives based on the New Approach and the Global Approach set out only the essential product requirements, while the detailed technical requirements are set out in the technical specifications and harmonized standards. Compliance with EU standards ensures compliance with the essential requirements of the guidelines.
Depending on the requirements for safety, health, hygiene and environmental protection, the manufacturer assesses the conformity of the products with the requirements of the guidelines and standards, and engages the Notified Body (TUV NORD) to perform the EC-type examination of the product. The new approach is a modular approach and defines the following product conformity assessment modules:
- Module A: Internal production control.
- Module B: EC-type examination.
- Module C: Conformity to type.
- Module D: Production quality assurance.
- Module E: Product quality assurance.
- Module F: Product verification.
- Module G: Unit verification.
- Module H: Full quality assurance.
Guidelines define the implementation of the certification process, and the procedure can be carried out by the manufacturer or by the Notified body. When guidelines define an obligation to involve a Notified body in the certification process, the Notified body examines the development, examines the manufacturer's manufacture according to a certified production quality system and/or examines the final product in order to confirm the essential requirements. CE marking may be applied on the product only after it has been approved by the Notified body.
TÜV NORD is a Notified body and certifies products in the following areas:
- Pressure equipment and pressure vessels
- Medical products
- Explosive protection ATEX
- Security equipment
- Toy safety
- Construction products etc.
When the Notified body is the supervisor of the manufacturing process or product testing, then the CE mark is followed by the identification number of the Notified body
TÜV NORD is a Notified body with number 0045.
So far, the European Commission has issued 23 Guidelines for the New Approach, and 4 Guidelines are in process of preparation. Depending on the features, a product may belong to the area covered in one of the Guidelines.
The Guidelines feature three sets of requirements according to:
- Harmonized European standards
- European technical requirements
- National technical regulations.
As the Republic of Macedonia has the obligation to harmonize its legal and technical regulations with the EU legislation in the process of EU accession, the national technical regulations are being harmonized with the guidelines and refer to the European standards and norms.
Therefore, it is expected that the number of applications from manufacturers for CE certification of products will increase, both due to the harmonized legislation with the European legislation and due to the obligations of EU exporters to place the CE marking on their products.