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2016-10-11-01 NIST- TEL MRA Part I SAAR October 2016 Final

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TEL MRA Report - Part I
NIST – DEPT. OF COMMERCE
OCTOBER 11, 2016
RAMONA SAAR
Topics
• Introduction
• Mutual Recognition Agreements/Arrangements
• About NIST
• NIST TEL MRA Program Office
• Key Support Activities
•US-EU MRA
About Mutual Recognition Arrangements/Agreements
• Conformity assessment of telecom equipment subject to regulatory
requirements
•Government to government agreements
• Each economy maintains its technical requirements, regulations and
conformity assessment scheme/rules
•Recognition
• Formal recognition of conformity assessment bodies (CABs)
•Acceptance
• Acceptance of the conformity assessment results by the partner
economy in accordance with their requirements/regulations/rule
NIST
National Institute of Standards and Technology (NIST)
MEASURE. INNOVATE. LEAD.
Working with industry and science to advance innovation
and
improve quality of life.
NIST TEL MRA Program Office
• U.S. CAB Designation Program
• Designate U.S. CABS to MRA partners
• Designate U.S. TCBs to the FCC
• CB Accreditation Body Recognition Program – NVCASE
• Evaluate and formally recognize U.S. CB accreditation bodies
•Lab and NB Accreditation Body Listing Programs
• Evaluate and List US testing lab accreditation bodies used for MRAs
• Evaluate and List US NB accreditation bodies for EU MRA
Key Support Activities
• Serve on the U.S. government delegation for Telecom MRA negotiations with
MRA Partners
• USTR (lead agency)
• FCC
• NIST
• Stakeholders (ABs, CABs, other interested parties)
•Process designation requests for U.S. CABs to MRA Partners
•Serve as a liaison between the CABs and MRA partner regulatory agencies
• Attend relevant MRA Partner and industry meetings
• Disseminate information/reports to stakeholders
US-EU MRA
EMC DIRECTIVE (EMCD)
RADIO EQUIPMENT DIRECTIVE (RED)
RADIO & TELEPHONE TERMINAL EQUIPMENT DIRECTIVE (R&TTED)
US-EU MRA – Scope
U.S. (NIST)
Designates/Notifies
NBs to the EU
EU Designates testing
labs and TCBs to the U.S.
(FCC)
STATUS OF THE DIRECTIVES
EMC Directive 2014/30/EU
•Text of the EMC Directive
•Effective as of April 20, 2016
• Awaiting publication of the EC’s Guide for the EMC Directive 2014/30/EU
• May 4, 2016 version (Final Draft) was circulated
•NANDO List of Notified Bodies approved under the new EMC Directive
• 6 U.S. NBs have completed the process to date
Radio Equipment Directive 2014/53/EC
•Text of the RED
•Effective as of June 13, 2016
• EC’s Guide to the RE Directive 2014/53/EU under Development
• RED Guide Working Group met September 20-21, 2016
• September 22, 2016 version is being circulated
•NANDO List of Notified Bodies approved under the new RED
• 6 U.S. NBs have completed the process to date
R&TTE Directive 1999/5/EC
• Expiration of all NBs for the R&TTE Directive as of June 13, 2017
• May continue to be applied to products within the scope of the R&TTE
Directive that remain in the scope of the RED (2014/53/EC) that are placed on
the market until June 13, 2017
• Use must be discontinued for products within the scope of the R&TTE Directive
that are outside the scope of the RED – effective as of June 13, 2016
• Terminal Equipment, for example
OBTAINING NOTIFIED BODY STATUS
Obtaining NB Status
Obtain Accreditation for NB activities – NIST Listed ABs
Apply to NIST; provide supporting documents
NIST evaluation of application materials
NIST notification to the EC via NANDO; 60 Day Review
Name on NANDO Notified Bodies List = NB Status achieved
Acceptable NB Accreditation Bodies (ABs)
• ABs that have applied and been found acceptable for use by CABs
seeking accreditation for Notified Body activities under the new EMCD
and RED
•NIST-Listed ABs for NBs:
◦ A2LA: NB accreditation under ISO/IEC 17065, ISO/IEC 17020, ISO/IEC
17025
◦ ANAB: NB accreditation under ISO/IEC 17020
◦ ANSI: NB accreditation under ISO/IEC 17065
Documents Published By NIST
• Dated November 15, 2015; Circulated November 23, 2015
• Requirements & Application for U.S. Conformity Assessment Bodies
Seeking Electromagnetic Compatibility (EMC) Directive 2014/30/EU
Notified Body Status
• Requirements & Application for U.S. Conformity Assessment Bodies
Seeking Radio Equipment Directive (RED) 2014/53/EU Notified Body
Status
Revisions needed to both documents.
Status of US NB Applications
WHEN MUST AN NB BE USED?
Cases for Mandatory Use of NB
RED Only
•When a manufacturer assesses compliance of radio equipment under the essential
requirements of RED Articles 3.2 (and 3.3), and the harmonized standards are
◦(a) applied only in part
◦(b) available but not applied; or
◦(c) are not available
•Notified Body involvement is mandatory (per RED Article 17.4).
• NB Reporting Obligation Applies: NB must inform Member States of EU-type
examination certificates issued where harmonized standards were available but not
used in full or not applied at all. [Cases (a) and (b) above].
◦Mechanism for this notification needs to be developed.
STATUS OF HARMONIZED STANDARDS
Status of Harmonized Standards
•EMCD List of Harmonized Standards
•LVD List of Harmonized Standards
•RED List of Harmonized Standards
• ETSI ONLINE Work Program
• Extensive work program
• Some HS will not be finished by June 13, 2017
MORE REQUIREMENTS TO COME
Delegated and Implementing Acts
RED Article 10.10
•The Commission is working on an implementing act specifying how information on (1)
restrictions on putting into service or (2) requirements for authorization of use needs to be
presented.
• Draft already circulated
RED Article 3
•The Commission may adopt delegated acts specifying which categories or classes of radio
equipment are concerned by each of the essential requirements in RED Article 3.3
RED Article 5
• The Commission may adopt delegated acts specifying which categories of equipment will need
to be registered (as of June 12, 2018) in a central system prior to placement on the market, and
adopt implementing acts specifying the operational rules for registration and affixing of a
registration number.
NB REPORTING OBLIGATIONS:
NB CERTIFICATE DATABASE
NB Certificate Database
• NBs must share certain information with other NBs
• refused, withdrawn, restricted or suspended categories of EU
Type-examination Certificates
•The EUANB and REDCA have worked with the EC to develop an
NB Certificate Database that will be for NB use only
• The EUANB has issued a procedure providing definitions and
examples for the categories and guidance on data entry
Data to be Uploaded to Database
NB name:
NB number:
NB Contact person:
NB Contact email address:
Product category:
Manufacturer name:
Registered Trade name or Mark:
Additional product indications (type or model number):
Status of Certificate (withdrawn, refused, suspended, restricted)
Product Restrictions (if appropriate)
How will the NB Use the Database?
•Manufacturer/NB Client:
• Lodge an application with a single notified body and include a written
declaration that the same application has not been lodged with any other
notified body
•NB
• Disclose to Manufacturer/Client all reporting obligations (via contract)
• Check NB Certificate Database for any entries that may be related to the
projects being requested
ON-GOING RESPONSIBILITIES OF
THE NB
AND
THE CLIENT/MANUFACTURER
Product Modifications
• Manufacture/NB Client:
◦Inform the NB of modifications that may affect the conformity of the radio
equipment with the essential requirements or the conditions for validity of
the EU Type Examination Procedure
•NB:
◦Such modifications require additional approval in the form of an addition to
the original EU-type examination certificate
Changes to Requirements
• NB:
• Stay up to date with the generally acknowledged state of the art which indicate that
products related to the EU Type Examination Certificates issued by the NB may no
longer comply
• Determine whether changes require further investigation
• Inform the manufacturer accordingly
• Require the manufacturer to take appropriate corrective measures (and suspend or
withdraw the EU-type examination certificate if necessary)
• Where corrective measures are not taken or do not have the required effect, restrict,
suspend or withdraw the EU-type examination certificate as appropriate
•Manufacturer/Client
• Manufacturers who have reason to believe that radio equipment they placed on the
market is no longer in conformity must immediately take the corrective measures to
bring the radio equipment into conformity, or to withdraw or recall it, if appropriate.
STAYING UP TO DATE WITH THE
GENERALLY ACKNOWLEDGED STATE OF THE ART….
WHAT DOES THIS MEAN?
Staying Informed
• NBs must participating in or staying informed about
◦- relevant standardization activities (CEN, CENELEC, ETSI….)
◦- the activities of the notified body coordination groups (EUANB/REDCA)
◦- the regulatory activities in the area of radio equipment and frequency
planning (for RED - EFIS)
• NBs must
◦Apply as general guidance the administrative decisions and documents
produced as a result of the work of the notified body coordination groups
Next Meeting of the Notified Body Groups
• Radio Equipment Directive Compliance Association (REDCA)
◦Radio Equipment Directive
◦November 16, 2016
• European Union Association of Notified Bodies (EUANB)
◦EMC Directive
◦November 17, 2016
Zagreb, Croatia
•
NIST will attend these meetings.
Summary
Coming soon….
◦New harmonized standards
◦European Commission RED and EMCD Guides
◦Interpretations by the EUANB and REDCA
◦NB Database
◦Delegated and implementing acts
Thank you for your attention.
Contact: mra@nist.gov (MRA Team)
ramona.saar@nist.gov (direct)
The NIST TEL MRA Report Continues with Part II
By Nathalie Rioux
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