Canadian Conformity Assessment Body—Requirements to become a Designated Body (DB) for the European Union

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1. Introduction

The Canada-European Union (EU) Comprehensive Economic and Trade Agreement (CETA) was signed on October 30, 2016, and entered into provisional application on September 21, 2017. The protocol on Conformity Assessment (hereafter CA-Protocol) in the CETA establishes the procedures for mutual recognition of European and Canadian accreditation bodies and conformity assessment bodies (CABs) for the purpose of accepting test reports and product certification issued by recognized CABs.  

2. Notifying authority

Each Member-State has designated a notifying authority responsible for the assessment, notification and monitoring of conformity assessment bodies. The designation requests of a Canadian CAB is, however, sent to the European Commission (EC) via the New Approach Notified and Designated Organisations (NANDO).

2.1 European directives available to Canadian CABs for the Designated Body status

3. General requirements for Canadian CABs

4. Application requirements and processes for Canadian CABs

Online designation application forms as well as lists of required documentation can be found for:

1. Canadian Testing Laboratories (TL): in section 7 of DES-LAB, Procedure for Designation and Recognition of Canadian Testing Laboratories

As per the Blue Guide on the implementation of EU products rules 2016, accreditation to ISO/IEC 17025 is not considered sufficient on its own for module B. Thus, Canadian testing laboratories applying for Designated Body status (equivalent to Notified Body’s status, which is reserved for EU bodies) must submit the following documents:

  • The Radio Equipment Directive (RED)
    • a description of the conformity assessment activities;
    • conformity assessment module(s) requested;
    • the list of radio equipment for which the body is competent;
    • the certificate and scope of accreditation to ISO/IEC 17025; and
    • all the documentary evidence necessary for the verification, recognition and regular monitoring of its compliance with the requirements listed in Article 26.
  • The Electromagnetic Compatibility Directive (EMCD)
    • a description of the conformity assessment activities;
    • conformity assessment module(s) requested;
    • the list of apparatus for which the body is competent;
    • the certificate and scope of accreditation to ISO/IEC 17025; and
    • all the documentary evidence necessary for the verification, recognition and regular monitoring of its compliance with the requirements listed in Article 24.

2. Certification Bodies (CB): in section 5 of DES-CB, Procedure for the Designation of Canadian Certification Bodies (CB)

CABs accredited to ISO/IEC 17065 must submit the following documents, for:

  • The Radio Equipment Directive (RED)
    • a description of the conformity assessment activities;
    • conformity assessment module or modules;
    • their certificate and scope of accreditation; and
    • radio equipment for which the body claims to be competent.
  • Electromagnetic compatibility directive (EMCD)
    • a description of the conformity assessment activities;
    • conformity assessment module or modules;
    • their certificate and scope of accreditation; and
    • apparatus for which the body claims to be competent.

Once Innovation, Science and Economic Development Canada (ISED) receives an application and confirms its completeness, ISED will forward a designation request to the EC, who, under the terms of the CA-Protocol, has up to 60 days to respond.

Upon recognition by the European Commission, ISED will assign a unique CAB ID and issue a recognition letter to the CAB. The recognition letter will state the directive for which recognition has been granted, and the recognized CAB will be added to ISED’s list of Conformity Assessment Bodies

For renewals, recognized CABs shall update their recognition expiration date by submitting their renewed or extended ISO/IEC 17025 or ISO/IEC 17065 Scope(s) of Accreditation and Accreditation Certificate(s) through DES-LAB Application for Designation or Recognition of a Canadian Testing Laboratory or DES-CB Application for Designation of a Canadian Certification Body.

5. About the CETA Protocol on mutual acceptance of the results of conformity assessment

Of the 11 categories of goods listed in Annex 1 of the CA-Protocol, ISED supports and serves as the designating authority for the following two (2) categories:

  • radio and telecommunication terminal equipment
  • electromagnetic compatibility (EMC)

6. For more information

For more information about the Canada-European Union CETA CA-Protocol, please contact MRA Admin.