- February 22, 2018
- Posted by: admin
- Category: CE Certification, CE Marking, Certification, Product Certification
How to achieve CE Certification approval, CE Mark testing and meet all CE Marking requirements for my product?
CE Marking Certification is Passport of your Products for entry in Europe. Our Equipment certifications are engaged to assist the progress of the important positioning of your Equipment’son the European Countries. EU-CERT Certification Body with it is lots of experience and the international network can help you reach your goals.
Standing for the French Conformité Européenne, the CE Marking has become the passport for Equipment groups wishing to enter the European market. There is a list of steps defined below for CE Marking Certification approval. Depending upon your Equipment and the nature of the risks it presents
Decide if any directives apply to your Equipment. If more than one applies you will have to comply with all of them.
Decide the range to which your Equipment complies with the important requirements for design and manufacturing in the suitable directives.
Choose the conformity assessment procedure from the options modules called out by the directive for your Equipment. There are various modules ready for use the Conformity Assessment Procedures as listed below:
- Module A: internal production control
- Module Aa: intervention of an NB (Notified Body)
- Module B: EC type examination
- Module C: Conformity to type
- Module D: Production quality assurance
- Module E: Equipment quality assurance
- Module F: Equipment verification
- Module G: Unit verification
- Module H: Full quality assurance
The directives commonly use a list of questions about the nature of your Equipment to categorize the level of risk and refer to a chart called Conformity Assessment Procedures. The chart covers all of the acceptable choice available to a manufacturer to confirm their Equipment and affix the CE Mark.
The choice for Equipment’s with Nominal risk includes self-certification where the manufacturer prepares a Declaration of Conformity and affixes the CE Mark to their own Equipment.
Many directives require Equipment’s/systems, products with higher risks to be individually certified this must be done by an NB (Notified Body). This is an organization that has been approved by a Member Government and has been notified by the European Commission. Notified bodies (NB) serve as separate testing laboratories and perform the steps called out by directives. They must have the mandatory qualifications to meet the testing needs set forth in the directives. Notified bodies (NB) may be a private sector organization or a government agency. Manufacturers may select an (NB) notified body in any member state of the European Union. Lists of (NB) notified bodies are published by the European Commission in the Official Journal of the European Communities.
A Notified Body is usually able to offer some of the services required:
- Product/Equipment testing
- Type examination certificate issue
- Technical File and design dossier evaluation
- Surveillance of product/Equipment and quality system
- Identification of standards
If your Equipment’s need to be certified by an NB (Notified Body), then you will need to following 2 Steps:
Select the applicable product/Equipment standards and testing methods for your Equipment and select an NB (Notified Body).
Establish an Authorized Representative in the European Union for your Equipment.
Some directives need that a manufacturer names in the European Union an authorized representative to produce Technical File in a timely fashion when called upon to do so. The CE Certification itself is not meant to give information about the Equipment to Surveillance Authorities.
Technical File: The directives require for many Equipment’s that a Technical File is prepared by the manufacturer. The Technical File holds details that verify the testing was regulated properly and that the Equipment complies with relevant standards.
Make a Declaration of Conformity.
The Declaration of Conformity must include information acceptable for tracing the product/Equipment back to the manufacturer or the authorized representative in the European Union. It may cover a list the directives and standards that your product/Equipment conforms to, Equipment identification, the manufacturer’s name, address, and signature.
Register your product/Equipment in EU
Many Equipment’s/products, for the case, Class I Medical Devices, are mandatory to be registered in the EU and, if confirmed, get a Certificate of Registration. Without this Certificate of Registration, the Equipment’s/products are NOT allowed to be affixed with the CE Mark and be established on the market.
Affix the CE Mark to your Equipment /product.
There are particular standards conform to CE Mark Certification. These standards address the size and location of the Marking, affixing the CE Mark to Equipment’s, packaging and material or documents shipped with the Equipment, and particular limitations on when and who is granted to affix the CE Mark Certificate.
As a Certification body to the European Union, EU-CERT will help your company to get compliance testing in a domain regulated by EC directives Low-voltage directive, machinery directive, toys directive, EMC directive and etc… Within the framework of the CE Mark, we are able to provide all the requisite services on a one-stop basis. The mandatory areas of the CE conformity assessment include the following
- Type approval testing
- Compatibility testing electromagnetic, biological compatibility etc.
- Safety testing in our own testing labs
- Examination of Equipment design
- Preparation of expert appraisal reports
- Certification of quality systems
We help companies as early as the development stage of new Types of equipment by answering all questions related to the application of regulations, occupational safety and health provisions connected with the safety of the product.
If you are Searching for secrets about CE certification, Check Here top 12 secrets about CE marking certification of electrical and electronic products
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