CE Marking INR - 15,000.00
CE marking is a declaration by manufacturer that the product fulfills the requirements of the relevant European health, safety & environmental protection legislations, as per European Conformity Directives. It is the mandatory conformity marking for wide range of products sold, traded, imported in European Economic Zone. It is recognized worldwide even to people who are not familiar with European Economic Zone. CE mark consists of the four digit identification no. of the Concerned Body involved in the conformity assessment procedure. CE marking responsibility lies with whoever deal the product in the market of EU.
As per European Commission CE marking is the “passport” of products which allow a manufacturer to freely circulate their products in European Market. It is estimated that more than 50% product exported to Europe market. All other goods are subject to General Product Safety Directive 92/59/EC, which doesn’t require CE marking. “CE” is derived from French word “Conformite Europeene” i.e. meeting the requirement of product of Europe.
CE is the declaration made by the manufacturer to demonstrate the fulfilment of the EU requirements relating to a product and goods bearing the CE marking being manufactured and traded in European market. CE Marking on a product indicates to governmental officials that the product can be legally placed on the market in Europe, essential the requirements of the relevant European health, safety and environmental protection legislations, in other words also known as Product Directives.
CE testing ensures that products being traded in Europe (ie. EU & EFTA- European Free Trade Area countries) are complying the all the requirements and regulations relevant to the product. It ensures the product are of top quality and does not harm in terms of health, environment and safety issues. It also ensures that products follows the directive of European Commission for relevant product.
It depends on cases to case, each Medical Device manufacturer must choose its own and most suitable conformity module(s) which address(es) its product categories & business requirements.
Its important to select reliable and authentic European Authorized Representative like Tax Sigma, before you choose a Notified Body from more than 100 of them based in several countries; As your Auth Rep, Tax Sigma will particularly assist you in classifying and categorising your product before its submission to the concerned Notified Body.
Steps to obtain CE Marking for your Medical Devices
- Appoint Tax Sigma as your single European Authorized Representative within the 30 EU+EFTA countries.
- Tax Sigma will help you in identifying all EU Directives applicable to your product.
- Tax Sigma will help you in classifying your device.
- Tax Sigma will help you in selecting the most appropriate conformity assessment module.
- Tax Sigma will help you in selecting your Notified Body, if your chosen conformity module requires so, to perform the third-party conformity assessment tasks.
- Tax Sigma will help you in assessing your device according to Essential Requirements.
- Tax Sigma will help you in preparing the "Technical File".
- Tax Sigma will help you in preparing your "Declaration of Conformity".
- You affix the CE Marking on your device and start to sell
Whether you require complete assistance for the entire process or guidance for certain parts, we are always to help you:
- Achieve compliance, offering you practical and effective suggestions, as well as advice and guidance
- Determine which European Commission directives & standards would apply to your products
- Define responsibilities under EU product safety directives
- Understand the concept of diverse certification and the various steps that are required
- Identify whether a notified body (NoBo) is needed to enable you to achieve compliance
CE marking required to be passed through various stages before placing on product. Steps to be followed likewise :
Stage 1: Identify the applicable Directive(s)
Stage 2: Identify the applicable requirements of the Directive(s)
Stage 3: Identify an appropriate route to conformity
Stage 4: Assessment of the product's conformity
Stage 5: Compile the technical documentation
Stage 6: Make a declaration and affix the CE marking