Conformity Assessment Bodies Validated for the Operational Phase
The following conformity assessment bodies (CABs) have been formally accepted under operational phase of the Mutual Recognition Agreement between the United States and the European Community (U.S.-EU MRA) and serve as Notified Bodies under the EMC and R&TTE Directives.
In accordance with formal notification from the European Union, the designation of these organizations by NIST as U.S. Conformity Assessment Bodies (CABs) for the relevant annex(es) have been validated.
Role of Notified Bodies for the EMC Directive
Notified Bodies recognized under the EMC Directive have been deemed competent to review the technical documentation of the manufacturer's equipment and assess whether the technical documentation properly demonstrates that the relevant aspects of the essential requirements of the EMC Directive have been met.
Role of Notified Bodies for the R&TTE Directive
Under this directive - Notified Bodies can be approved for up to three conformity assessment tasks:
- identify the essential radio test suites (Annex III of the Directive);
- review and give opinions on technical construction files (Annex IV of the Directive)
- assess and perform periodic surveillance of manufacturers' full quality assurance systems (Annex V of the Directive).
Notified Bodies are specifically not to carry out testing or prepare test reports for the equipment for which a statement of opinion is being issued.
NIST continues to work with validated CABs throughout the operational phase. All validated CABs sign and return a CAB Declaration form, which states that each CAB is responsible for notifying NIST of any relevant changes such as accreditation status, liability insurance, and key staff involved with projects under the MRA. All CABs must fully understand the terms under which they are obligated to operate as a condition of designation as a CAB. As a designating authority, NIST is responsible for monitoring CAB performance to ensure continued competence under the terms of the MRA.