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: [email protected] (MRA Team) [email protected] (direct) The NIST TEL MRA Report Continues with Part II By Nathalie Rioux
