What is CE Marking?

The CE marking is a key indicator of a product's compliance with EU (European Union) legislation and enables the free movement of products within the European market. By affixing the CE marking on a product, a manufacturer is declaring, at their sole responsibility, conformity with all of the legal requirements to achieve CE marking and therefore ensuring validity for that product to be sold throughout the EEA - European Economic Area. This also applies to products made in third countries which are sold in the EEA. CE marking does not indicate that a product was made in the EEA but states only that the product has been assessed before being placed on the market and thus satisfies the legislative requirements (e.g. a harmonized level of safety) to be sold there. It means that the manufacturer has verified that the product complies with all relevant essential requirements (such as safety, health, environmental protection requirements) of the applicable directive(s) or, if stipulated in the directive(s), has had it examined by a notified conformity assessment body. However, not all products must bear the CE marking. Only those product categories subject to specific directives that provide for the CE marking are required to be CE-marked.

The role of a Notified Body in CE marking

Where a Directive or Regulation requires products or systems to be independently tested, certified or inspected you will need to use the services of a Notified Body. This is an organization that has been notified to the European Commission by a Member State.

BTH can support you to understand and meet the latest requirements of CE Marking. We can serve through our notified body channel partner for all your CE Marking needs covering a number of Directives and Regulations enabling you to achieve European market access with the CE marking.

Requirements for CE marking range from a manufacturer’s declaration, up to mandatory full Notified Body assessment of the product and manufacturing controls. We can work with you throughout this process, so when you choose us, you can be confident that you’re working with a trusted brand with a strong international reputation and world-class expertise in product certification.

CE-marking conformity assessment services:

• Standards identification
• Technical file evaluation
• Gap analysis
• Initial type testing and Type examination
• Technical audit of Product according to applicable directives & standards
• Final assessment of Technical File and issuance of certificate
• Our team of qualified and experienced experts to support you to certify your products for CE Marking under various directives.