Marcação CE (Conformité Européene)

The CE marking is an innovative instrument developed in the EU to remove barriers to the free movement of goods and to protect the public interest. The common framework for marketing products is regulated by Decision 768/2008/EC of the European Parliament and of the Council, dated 9 July 2008.

Decision 768/2008/EC defines CE marking as “the marking by which the manufacturer demonstrates that the product complies with all applicable requirements for its placing on the market, as set out in the EU harmonization legislation that provides for its affixing.” Legislative harmonization among EU member states is the basis for standardizing CE marking formalities, ensuring compliance in several areas (absence of health-hazardous materials, usage limitations, expiry dates, accident prevention, among others), which are essential for trade within the EU. Thus, CE marking is the evidence provided by the manufacturer that its industrial products comply with the requirements established in the EU “New Approach” directives.

Each country is responsible for ensuring compliance with the requirements and for repealing any legislation contrary to its application within its territory. CE marking is affixed by the manufacturer on their products and results from a successful conformity assessment process, as stipulated in the applicable EU legislation for the product in question. By doing so, the manufacturer assumes full responsibility for the product’s compliance with the current European legal directives.

The process to obtain CE marking involves the following steps:

1. Identify the directive(s) and harmonized standards applicable to the product
    
2. Verify that the product meets the specific requirements
    
3. Determine whether an independent conformity assessment by a Notified Body is required
    
4. Test the product and verify its compliance
    
5. Prepare and keep the mandatory technical documentation available
    
6. Affix the CE marking and issue the “CE Declaration of Conformity”
    

In conclusion, regardless of the involvement of a Notified Body, the manufacturer is responsible for affixing the CE marking, issuing the “CE Declaration of Conformity,” and ensuring the conformity assessment of the product. Notification to the European Commission and maintenance of the updated NANDO database at the national level is the responsibility of the Portuguese Institute for Quality (IPQ, 2015).

Regarding ITV (Inspections and Technical Verification), CE marking is mandatory for certain products (Decision 768/2008/EC of the European Parliament and of the Council, 2008), such as Personal Protective Equipment (PPE).