What is conformity assessment?
Conformity assessment is the activity of demonstrating that a product/ process / service, a person or a system conforms to or meets the related specified requirements. The methods for demonstrating conformity include testing, inspection and certification. Bodies performing e.g. testing, inspection or certification activities are referred to as Conformity Assessment Bodies.
What is CE marking?
CE marking is a part of the EU’s harmonisation legislation. By affixing the CE marking to a product, the manufacturer declares on his sole responsibility that the product conforms to all applicable requirements of the relevant EU legislation, and that the appropriate conformity assessment procedures have been successfully completed. This is irrespectively of whether a third party has been involved in the conformity assessment process or not.
The CE marking has to be affixed before the product is placed on the Union market and throughout the EEA (European Economic Area). Not all products must have CE marking. It is compulsory only for most of the products covered by the New Approach Directives. It is forbidden to affix CE marking to other products. CE marking does not:
- indicate that the product was made in the European Union or the EEA
- serve commercial purposes i.e. it is not a marketing tool
- indicate that products have been approved as safe by the EU or by another authority
What is the difference between CE marking and other markings?
Through the CE marking the manufacturer indicates that the product is in conformity with all the essential requirements of the applicable EU legislation.
Products may bear other markings which are not covered by Union legislation. They may be used to contribute to the improvement of consumer protection; therefore they have a different meaning and purpose as the CE marking.
What is an EC Declaration of Conformity?
The manufacturer (or the authorised representative established within the EU) must draw up and sign an EC declaration of conformity (DoC) as part of the conformity assessment procedure provided for in the applicable legislation. This means that the manufacturer declares that his / her products fulfil the essential requirements of the applicable legislation and the manufacturer assumes responsibility for the compliance of the product.
What are notified bodies?
Notified Bodies carry out the mandatory conformity assessment procedures according to the applicable legislation when a third party is required. These bodies are being notified by the Member States, who assess if an independent third party body is competent to carry out conformity assessment in accordance with the requirements and fulfils further specific requirements of the applicable legislation.