an independent third party organization appointed by a Member State to assess conformity of the design or the quality assurance system in accordance with the requirements laid down in the Directive
a testing agency authorized by the EU to verify compliance with (a) specific Directive(s)
A body (usually a company) approved by the competent authority to assess manufacturers' compliance with the MDD in accordance with its provisions. Such bodies are 'notified' to the European Commission and as such may operate anywhere within the EU.
Usually a government agency in a member state of the European Union that carries out conformity assessment procedures for some classes of medical devices, telecommunications terminal equipment, and radio systems. Only an NB may issue a European Community Type Examination Certificate, which confirms that a product has been evaluated against the applicable standards and that the manufacturer's quality system has been audited. In some cases the NB may require a Competent Body to do testing.
Monitors that we satisfy quality systems and MDD, the EU directive.
A Notified Body is an organization, appointed by the EU member's National Authority (a.k.a. Competent Authority), which has the technical competence to evaluate compliance to a directive. They do not necessarily have test capabilities.