Regulation 59 Interpretation of Part VII

In this Part F1...—

• F2“registrable device” means a device in respect of which, in accordance with the Medical Devices Directives, registration is required with the competent authorities of a Member State or (where appropriate) a State which is a Party to an Association Agreement;

• “relevant device” means a device that is a “relevant device” for the purposes of Part II, III or IV F3....