Notified Bodies

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Accreditation Body

When selecting an Accreditation Body it is important to understand their scope and extent of services they provide. If you do not it may be necessary to change your accreditation body as each EU Product Directive under the New Approach format specifies Bodies able to certify your Quality System and carry out a product assessment if required. Careful selection is therefore vital.

Notified Bodies are responsible for examining technical files and design dossiers, verifying that products have been made to the technical files and that both files and products meet the requirements of the relevant European Directives and Standards. They will also carry out any assessment of the Quality Management System and the follow up surveillance required. For each product type the notified body has specified responsibilities for ensuring products have been properly tested and examined. The notified body must be based in the EU or be part of a mutual recognition agreement and approved by the European Union.

You must select a Notified Body specific to the Directive.

Competent bodies must be based in the European Union and listed by the relevant agency. (In the UK this means approval by UKAS - United Kingdom Accreditation Service or equal). Their primary function is to examine and test products to EU standards and review technical documentation to verify that products meet the CE requirements.

Competent Authority is the regulatory body responsible for the implementation of the applicable EU Directive and for the approval of Notified Bodies for Medical Devices. Additionally, when a company chooses NOT to introduce a quality system to their primary function is to examine and test products to EU standards and review technical documentation to verify that products meet the CE requirements and to monitor product reports and customer feedback. For the Medical Devices the Vigilance System is mandatory. In the UK this is the responsibility of the MHRA.