What is CE Certification?
CE marking indicates that a product has been assessed by the manufacturer and deemed to meet EU safety, health and environmental protection requirements. It is required for products manufactured anywhere in the world that are then marketed in the EU.
GET CERTIFIED IN 5 STEPS
TRAINING AND DOCUMENTATION. Once you have agreed to our quotation, Our team will provide the required trainings to you and will complete the documentation work required for CE MARK certification.
IMPLEMENTATION AND REVIEW.
FINAL AUDIT BY CERTIFICATION BODY.
RECEIVE CERTIFICATE.
How do I get CE certification?
How to obtain CE marking?
Identify the EU requirements for your product.
Check whether your product meets the specific requirements.
Check whether your product must be tested by a Notified Body.
Test your product.
Compile the technical dossier.
Affix the CE marking and draft a declaration of conformity.
How much does it cost to make a CE?
You don’t buy CE marking by the pound. The price of CE certification can differ greatly from one product to another. I have seen prices range from $ 64 to $ 64,000.
What are the documents required for CE marking?
Documents Required for CE Certification
Product Details/description.
Product test Report.
Manufacturer Declaration.
Proof of product conformity.
Copy of Risk Assessment.
How long does it take to get a CE mark?
On average, the CE marking process takes four to six weeks. It can also take longer or shorter depending on test results, whether the product still needs to be modified, and how quickly the technical documentation can be supplied.
How do I CE mark a medical device?
In order to obtain a CE mark, manufacturers of medical devices will need to:
classify their device and select the appropriate Conformity Assessment Route;
prepare a technical file;
undertake a Conformity Assessment procedure;
obtain a certificate of conformity from the Notified Body .