CE mark is a kind of compliance mark for placing your product in EU market. It opens the doors for all the 28 major countries of EU for the device and also symbolizes the highest level of product quality. One question that frequently confuses people is that: ‘Is it an EC Certification or a CE Certification? The answer to this is that there is no difference between the two. The correct name for the certificate is ‘EC Certificate’. They are commonly referred to as ‘CE Certificates’ because of the symbol that is used on the products.
There are many steps involved in obtaining the CE mark. The first step is the defining the intended use of the device according to which is classification of the device is done as per the Annex IX of the medical device (MDD 93/42/EEC).The classification is often done based on the risk a medical device imposes. The lower risk device is class 1 and higher risk is class II and highest risk device is class III device.
If a product falls is Class I then the product can be self certified without the involvement of a notified body when as the class II and class III device require Notified body. for both self certification case and other certification a technical dossier is prepared for the product. This technical dossier contains all the information about the product from the raw material to test performed on the product , risk analysis , ESR, declaration of conformity, Manufacturing process description etc.
Once this file is approved by the NB then the onsite audit of the organization is done to ensure the things are actually at place as described in the technical dossier. The organization may or may not receive non conformity (NCs) during the audits. The major NC’s needs to be resolved within one month where as the minor can be resolved in 2-3 months. Once all NC’s are cleared the organization is finally issued the CE certification having a validity of 5 years subjected to surveillance every year.
While the process of CE is not very easy but the proper consultancy and guidance can help an organization to obtain CE smoothly. Med devices Life science Pvt. Ltd. provides consultancy for CE marking. We are in this field from the last 25 years and our organization is one stop solution for all the process & procedures related to the CE certification .We have our association with the Notified bodies in Europe and highly qualified approved auditor having the in depth knowledge of CE mark. Right from the product classification to preparation of technical dossier, conducting audit for compliance and providing the certificate we have gain our expertise in all the fields.