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Notice to Notified Bodies (NBs) Regarding Options for Listing EU NB Scopes

PUBLIC NOTICE PRO-NT-126 Issued: 2019-8-21, Revision: 1

References PRO-FR-105-ISO/IEC 17065: Checklist for Accreditation Requirements: ISO/IEC 17065
EU Radio Equipment Directive (RED) 2014/53/EU - Annex III (Module B: EU-Type Examination) only; taking into account EA-2/17 M:2016
EU EMC Directive 2014/30/EU - Annex III - Part A (Module B: EU-Type Examination); taking into account EA-2/17 M:2016
ISO/IEC 17065:2012, Conformity assessment- Requirements for bodies certifying products, processes, and services
1.1To provide ANSI accredited NBs with flexibility when specifying their EU scopes for the Radio Equipment Directive (RED) and the Electromagnetic Compatibility Directive (EMCD).
3Effective Date
3.1August 14, 2019
4.1For EU NB scope specification purposes, ANSI has traditionally used a list of devices provided by an applicant. This approach has also been used for re-accreditation purposes as well. Recently ANSI received a request to use a more generalized description for the purpose of listing a NBs scope for the RED and for the EMCD.
4.2ANSI has researched the possibility of making this available to any NB applicant or for the re-accreditation of an existing NB. Accordingly, ANSI reviewed the process and documents that NIST uses to notify a new or existing NB to the EU. ANSI has also reviewed the normative documents published by the EU regarding the accreditation, notification, and recognition of NBs. As a result of this research and review, ANSI has determined that the EU has not established a specific format for listing a NBs scope for the RED or the EMCD. Additionally, the listing provided in the NANDO database of recognized NBs uses a generalized approach in listing the scope(s) for a NB for both the RED and EMCD.
4.3However, as noted in ISO/IEC 17065 at clause 4.4, "Non-discriminatory conditions", a CAB may not discriminate against applicants in regard to access to their certification processes. Also, in ANSI's PRO-FR-105-ISO/IEC 17065, the Assessment Checklist requires an assessor to assess whether a NB, or prospective NBs, have processes and technically competent staff in place to appropriately evaluate all devices within their scope. Therefore, a NB or new applicant must have a documented process in place to address how they will evaluate an application for any type of device within their generalized scope of accreditation. ANSI will review the documentation of these necessary elements for accreditation during a NBs assessment.
4.4Accordingly, under the conditions noted above, ANSI will accept an EU NB scope of accreditation for the RED and EMCD that is generalized in nature and does not delineate specific devices that fall within a directive. Additionally, ANSI will continue to accept a list of devices appropriate for the applicable directive.

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