The CE Mark ("Conformité Européene") is a product distinctive mark providing conformance in accordance with specified requirements to European "Directives" [different to "Certification of Entity"]. Then what is a (European) directive? A series of specific standards that relate to product safety and effectiveness for manufacturers that relate to a granted "CE Mark". These Directives and granting of the CE Mark comes under a scheme set forth by the state countries within the boundaries of the European Union and others including Scandinavian region and Iceland (equally, other countries accept the Directives). 

To what products do these directives apply?

In a broad sense, apply when there could be impact to safety and the safe operation of a product (or service). Applies to a wide variety of products, it is important to indicate that CE Marking directives invokes  safety in protection of consumers, workers... safety and life:

• Maritime Equipment and Devices
• Medical Devices and equipment (MDD)
• Electrical and electronic devices and equipment
• Devices and equipment that require sustaining pressure
• Machinery whether electrical, combustion or otherwise
• Electrical and electronic equipment
• Medical devices and equipment
• Equipment for personal use relevant to safety / protection
• Operational Devices / Equipment to be used within an area or exposed to explosives

If your product falls within the grasp of the "Directives" then these are essential and you must addressed these directives from design through delivery. The "Directives" itself, once obtained will indicate the requirements on whether attestation and product certification is required by a "Notified Body". What is a Notified Body? Is a third party independent (services or otherwise) organization capable and authorized (by a government related organization / entity) to perform as the Directive requires (Notifying Body).

Can BRS help? BRS provides assessment against FDA | CFR, approved training venues, and base line (Gap) analysis as part of certification protocols to demonstrate compliance and a viable sources for official attestation. You can register your organization to meet the requirements of ISO 9001, ISO 22000 ... and through our GlobalNet partners achieve the "Directives" and attain Mark.

Equally to CE, we provide product mark through an attestation protocol as part of carrying a specific BRS Product Mark.