Are you focusing on the products to be sold in the European Market with bilateral trades or with other countries? As we look towards the global markets, there are specific customer needs and expectations and even legal regulations to a country-specific to comply with the requirements for safety and security. In similar lines, European markets need to have CE Marking Certification to get entry in the market for an efficient product but safety.
All users are interested to have the latest products in hand with no comparison with the safety. With the adoption of new updated technology all comes with inherent threats. To take care of all users the European Nations have implemented the European Directives as relevant basic requirements for all the products exported to European Union must meet all health and safety requirements.
Embellish of CE Mark
The CE Mark is the indication that your product meets the ‘Essential Requirements’ subject to a conformity assessment procedure provided in the Directives. The CE Mark has its shape and length specifications.
CE Marking Certification
A Conformité Européenne (CE) marking is a regulatory standard used for the sale and use in the European Economic Area (EEA). It works as a trade passport for the countries, in a way, to indicate that the products marketed in the market comply with the applicable European Union (EU) regulations and directives.
CE Markings are unique markings as they are not granted by a particular regulatory body (Certain critical products require conformity assessment by the Notified Body). Manufacturers are responsible for the use of CE Marking on their products.
In most cases, the CE marking will be on the product containing company name, company address, country of origin, model/serial number, and any other applicable marks. In case the products are too small the marking will impair the product, or for cables.
Key Principles for CE Marking
- The separation between EU legislation and European standardization with limited to the essential requirements
- Standards must offer a guarantee of quality
- Drawing up corresponding technical specification by standardization bodies
- Products manufactured in conformity with harmonized standards presumed to be with the conformity of the essential requirements of the EU Directives
- The essential requirements are not mandatory and remain voluntary
- Safeguard clauses require the Member States to withdraw unsafe products
CE Marking and Documentation
To affix a CE marking, companies must ensure that products are compliant with all applicable European regulations with properly followed with all the documentation. Many products require an accompanying declaration of conformity (DoC) duly signed by the manufacturer.
DoC must be backed up by a technical file
- Bill of materials (BOM), product descriptions, and/or design notes
- Type of testing Performed
- Certificates from approved test laboratories (notified bodies) (if the case may be)
CE Marking is a Must to have or not to!
Summary concerning CE Marking
- Product placing on the market needs to comply with the essential requirements of EU Directives
- The economic operator has the responsibility for the compliance of CE Marking on the product
- Filing of the Technical Documentation containing the DoC
- Start with the compliance approval before product design to increase success!
Great Britain, not an EU Nation
Great Britain has left the European Nation. As of January 1st, 2021 Great Britain has implemented the UKCA (UK Conformity Assessed) mark.
Steps for CE Marking
So, depending on the relevant EU Directives and their product safety requirements, the CE marking process may include the following steps:
- Identifying applicable EU directives as per the product
- Selecting relevant safety standards relevant to the product
- Notified body assessment conformity / Self Assessment
- External or internal lab testing of the product
- Compilation of technical documentation with all details of the product
- Creation of a Declaration of Conformity for due diligence
- Product marking and labelling the product
Need Assistance or have a query?
If you need CE marking or have any query related to CE Marking, contact Ascent ASSOCIATES for the necessary guidance and assistance. Our highly experienced team of experts will help you to solve your query and assist you in the implementation of CE Marking compliance for your product.