The European Community and Canada agree that, for medical devices covered by this Annex, each Party will recognise the conclusions of the conformity assessment carried out by the other Party and the certificate of compliance granted by the conformity assessment body of the other Party, without further reassessment.
Evropska skupnost in Kanada se sporazumeta, da bo pri medicinskih pripomočkih, ki jih zajema ta priloga, vsaka pogodbenica priznavala ugotovitve ugotavljanja skladnosti, ki jo je opravila druga pogodbenica, in certifikate skladnosti, ki jih je izdal organ za ugotavljanje skladnosti druge pogodbenice, brez ponovnega ugotavljanja.