U.S.-EU MRA and the U.S.–EEA EFTA States Mutual Recognition Agreements

Overview

Becoming a Notified Body (NB) for the European Union EMC and Radio Equipment Directives

Under the US-EU/EFTA Telecom Agreements:

-  Qualified US Conformity Assessment Body (CABs) may apply to the European Commission (EC) through NIST's Telecom MRA Program Office to become a Notified Body under specific EU Directives.

-  Qualified EU CABs may apply to the FCC through their Notifying Authority and the EC to become (1) an FCC recognized testing laboratory and/or (2) a Telecommunications Certification Body. [Please refer to FCC KDB 974614 and FCC KDB 641163 for further details on the FCC requirements.]

The information provided on this page is for US CABs seeking to become a Notified Body.

Prior to applying to NIST, prospective NBs are encouraged to contact NIST via mra [at] nist.gov (mra[at]nist[dot]gov) to review the requirements. 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.

Requirements and Application Information for Prospective NBs

1. NB Qualification for EMC Directive (2014/30/EU)

This Directive became effective on April 20, 2016.
 

NOTICE: Since November 30, 2015 - the NIST Telecom MRA Program Office has been accepting applications from U.S. CABs seeking NB Status for the EMC Directive (2014/30/EC). Please submit the completed application (Annex I) and supporting documents to mra [at] nist.gov (mra[at]nist[dot]gov).

Requirements and application information:

a.  NIST Requirements & Application (Version 4.0)
b.  NIST EMCD Assessment Checklist (Version 1.0)
c.  NB Reporting/Information Obligations (Version 3.0)

2. NB Qualification for Radio Equipment Directive (2014/53/EU)

This Directive became effective on June 13, 2016.

NOTICE:  Since November 30, 2015, the NIST Telecom MRA Program Office has been accepting applications from U.S. CABs seeking NB Status for the Radio Equipment Directive (RED). Please submit the completed application (Annex I) and supporting documents to mra [at] nist.gov (mra[at]nist[dot]gov).

Requirements and application information:

a. NIST Requirements & Application (Version 7.0) 
b.  RED NB Checklist Guide (Version 1.0)
c.  NIST RED NB Assessment Checklist - Main (Version 1.0)
d. NIST RED NB Assessment Checklist – Article 3.3g (mobile phones/Galileo) (Version 1.0)
e. NIST RED NB Assessment Checklist – Article 3.4 (common charger)  (Version 2.0, September 26, 2024)
f. NIST RED NB Assessment Checklist – Articles 3.3 d, e, f (cybersecurity) (Version 1.0, September 25, 2024)
g. NB Reporting/Information Obligations (Version 3.0)
h. NIST EU & UK Schemes – Scopes of Accreditation – Mandatory and Optional Content (Version 2.0, September 25, 2024)

3. NB Qualification: EMC Directive (2004/108/EC)

This version of the EMC Directive expired on April 20, 2016.

All Notified Bodies validated under this version of the EMC Directive expired on April 20, 2016.
 

4. NB Qualification: R&TTE Directive (1999/5/EC) 

This Directive expired on June 13, 2017. 

NIST Listed U.S. Accreditation Bodies (ABs) for NB Activities:

The following two ABs offer Notified Body accreditation programs that are acceptable for use by CABs seeking ISO/IEC 17065 accreditation for EU Notified Body activities under the EMC and RED Directives.

American Association for Laboratory Accreditation (A2LA) 
ANSI National Accreditation Board (ANAB) 

These ABs have successfully demonstrated compliance with the Accreditation Body qualifications included in Section 10 of the NIST Requirements & Application for U.S. Conformity Assessment Bodies Seeking Electromagnetic Compatibility (EMC) Directive 2014/30/EU Notified Body Status and the NIST Requirements & Application for U.S. Conformity Assessment Bodies Seeking EU Radio Equipment Directive (RED) 2014/53/EU Notified Body Status.

About the US-EU/EFTA Telecom Agreements:

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. Of the six product sectors included in the Agreement, NIST supports and serves as the Notifying Authority for the following two product sectors:

1. Telecommunications,
2. Electromagnetic Compatibility (EMC),

[The other product sectors of the Agreement included 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. Of the three product sectors included in the Agreement, NIST serves as the Notifying Authority for the following two product sectors: 

1. Telecommunications,
2. EMC, and

[The agreement also covered recreational craft.]

U.S.-EU and EFTA MRA Resources 

U.S. CABs Approved as Notified Bodies
All Notified Bodies/CABs for EMC and RED
Full text of the U.S.-EU MRA
Full text of the U.S.-EEA EFTA MRA
Blue Guide