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Agreement On Mutual Recognition Between The European Community And Canada

Mutual recognition agreements define the conditions under which one Party (third country) accepts the results of conformity assessment (e.B.g. tests or certifications) carried out by conformity assessment bodies (CABs) designated by the other Party (EU) to demonstrate compliance with the requirements of the first Party (third country), and vice versa. The authorities responsible for designating conformity assessment bodies under this Agreement are: the Johnson Government has moved away from these approaches. In its proposal for a Comprehensive Free Trade Agreement with the EU, the UK proposes an agreement on the mutual recognition of conformity assessment, “compatible” with the provisions of the EU-Canada agreement. It also proposes a separate agreement on the certification of marine equipment, “similar” to the EU`s agreement with the US. However, recent free trade agreements indicate a change in approach and acceptance of “traditional” SARs. For example, Articles 4(6) and 7(21)(4) of the EU-Korea Free Trade Agreement provide for the negotiation of mutual recognition of conformity assessment for goods and services. In the absence of agreement within the Joint Sectoral Group on any of the above-mentioned issues, the matter shall be referred to the Joint Committee in accordance with the Framework Agreement. The Parties shall enter the operational phase, provided that the CABs of each Party are represented in Appendix II. Recommendations on the list of CABs in Appendix II to this Annex shall be addressed to the Joint Sectoral Group by the participating designating/regulatory authorities listed in Appendix I, based on the results of the confidence programme.

The conformity assessment bodies that have been accepted by the Joint Sectoral Group are listed in Annex II, referring to their specific expertise in conformity assessment and to the areas of medical device technologies for which they are recognised. The corresponding regulatory/designating authority responsible for a CAB is also listed in Annex II. Proposals to limit the recognition of CAB capabilities should be based on objective and documented knowledge. The Joint Sectoral Group may recommend that a CAB not be included in Annex II, provided that there is documented evidence of its lack of expertise. . . .

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