This article applies to conformity assessment bodies established in countries outside the European Union.
Third-country conformity assessment bodies may be authorized to perform notified body activities if they meet EU requirements or an equivalent level of protection.
Conformity assessment bodies established under the law of a third country with which the Union has concluded an agreement may be authorised to carry out the activities of notified bodies under this Regulation, provided that they meet the requirements laid down in Article 31 or they ensure an equivalent level of compliance.