ANNEX IXU.K.CRITERIA FOR THE DESIGNATION OF NOTIFIED BODIES

2.The notified body and its staff must carry out the assessment and verification operations with the highest degree of professional integrity and the requisite competence in the field of medical devices and must be free from all pressures and inducements, particularly financial, which might influence their judgment or the results of the inspection, especially from persons or groups of persons with an interest in the results of the verifications.U.K.

Should the notified body subcontract specific tasks connected with the establishment and verification of the facts, it must first ensure that the subcontractor meets the provisions of the Directive. The notified body shall keep at the disposal of the national authorities the relevant documents assessing the subcontractor's qualifications and the work carried out by the subcontractor under this Directive.