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U.S.-EU MRA and the U.S.–EEA EFTA States Mutual Recognition Agreements
Overview
United States-European Union Mutual Recognition Agreement (U.S.-EU MRA)
The U.S.-EU MRA was signed on December 12, 1998, and includes the United States of America and the 27 member countries of the European Union. There are six product sectors included in the Agreement:
- Telecommunications,
- Electromagnetic Compatibility (EMC),
- Electrical Safety,
- Recreational Craft,
- Medical Devices, and
- Pharmaceutical Good Manufacturing Practices.
United States-EEA EFTA States Mutual Recognition Agreement (U.S.-EEA EFTA States MRA)
U.S.-EEA EFTA STATES MRA was signed on October 17, 2005. This Agreement includes the European Economic Area (EEA) European Free Trade Association (EFTA) countries of Norway, Iceland, and Liechtenstein (known collectively as the EEA EFTA States). The MRA is composed of a framework agreement and three sectoral annexes which mirror the provisions of the 1998 U.S.-EU MRA. The EEA EFTA States are fully integrated into the European Community single market and apply the same regulations as the EU. There are three product sectors included in the Agreement:
- Telecommunications,
- EMC, and
- Recreational Craft.
Becoming a Notified Body (NB) for the EU
Prior to applying to NIST, prospective NBs are encouraged to contact NIST via mra@nist.gov to review the requirements. Communications can be directed to Ramona Saar, NIST Program Manager (Telecom MRAs). Applicants that demonstrate, through the application process, compliance with the relevant requirements, will be nominated to the EU Commission for consideration as a NB. Once notified by the EU Commission, NBs are subject to on-going monitoring by NIST to ensure continued compliance with the requirements.
EU Commission R&TTE Directive Resources U.S.NBs are strongly encouraged to join the R&TTE Compliance Association (R&TTE CA) to stay up-to-date with technical (TGNs) and administrative information. To obtain more information, go to the R&TTE CA homepage. US NB personnel must also demonstrate technical competency for the related EMC and LVD Directives.
EU Commission EMC Directive Resources EMC Guidance and ADCO Market Surveillance U.S. NBs are strongly encouraged to join the EU Association of EMC Notified Bodies (EUANB) Interest group to stay up-to-date with technical (TGNs) and administrative information. To obtain more information, go to the CIRCABC host page. US NBs personnel must also demonstrate competency in the related R&TTE and LVD Directives. + Validated U.S. Conformity Assessment Bodies for EMC and R&TTE + All Notified Bodies/CABs for EMC and R&TTE + Full text of the U.S.-EU MRA + Full text of the U.S.-EEA EFTA MRA
NIST Criteria & References for NB Qualification - R&TTE Directive
R&TTE Guidance and ADCO Market Surveillance
NIST Criteria & References for NB Qualification - EMC Directive
U.S.-EU and EFTA MRA Resources
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