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CE Marking helps you be in conformity with health, safety and environmental protection regulations.

  • 2021-07-06

CE Marking helps you be in conformity with health, safety and environmental protection regulations.

CE marking is the conformity marking consisting of the letters CE. CE is an abbreviation for Conformity Europeenne, French for European Conformity. By affixing the CE marking to the product, a manufacturer indicates that he or she has assessed its conformity with EU health, safety and environmental protection legislation and confirms the product’s compliance with the relevant requirements. It is the manufacturer’s responsibility to verify that the products comply before placing them in the market. In some cases it is required to have the product examined by a designated third party conformity assessment body. The CE marking legislation has harmonized the product requirements throughout Europe and this means that once the manufacturer obtained the right to affix the CE marking his products can access all the countries of the European Union and circulate free between these countries without additional requirements or certification. 
Placing of the medical devices on the European market became a challenge. The medical device regulation DMD artistically raised the bar for manufacturers, for importers and for distributors. CE marking helps you to identify the regulatory requirements and this in turn helps you to find the missing parts right away to avoid unnecessary burg and to market your product faster and with less hassles. 
There are certain things to keep in mind regarding CE marking:
It is not the quality marking.
The CE requirements refer to safety rather than to the quality of the product. 
Obtaining a quality marking for the product is voluntary whereas the CE marking is mandatory for those products that it applies to. 
The CE marking is not an indication of origin and it does not mean that the product is produced in Europe. 
A product with CE marking may have been produced anywhere in the world. 
Another incorrect perception is that CE marked products have been tested and approved by an authority. The CE marking is always affixed under the sole responsibility of the manufacturer. In some cases it is required to involve a designated third party in the conformity assessment but even then the manufacturer remains responsible and liable. 
Which products require CE marking?
Not all products sold in the European Union need CE marking in order to get access to the EU market. Only products which are within the field of application of one or more selected groups of European Union technical regulations must be CE marked. Products that are not covered by CE legislation are not allowed to bear the CE marking. Some examples of products that require CE marking:
*Electrical and electronic equipment
*Medical devices
*Personal Protective Equipment
Samarth Consultants support medical device manufacturers in establishing quality management systems and compiling technical files. We plan and perform usability tests both in terms of on and off site training. With our help all our customers pass the audits and approval processes successfully with no exception. For medical devices, the manufacturers themselves should declare the conformity of their products by following a medical conformity procedure. Independent of the medical class of the medical device this procedure should be conducted by a notified regulatory body. Technical documents are compiled in accordance with the annexure.