The Secretary may seek information or documents relating to:
• the application of conformity assessment procedures or requirements comparable to those procedures;
• compliance with the essential principles;
• compliance with other requirements;
• distribution of, and other matters relating to, medical devices covered by exemptions under Part 4 - 6A or Part 4 - 7.
Note: There are additional obligations relating to notifying defects in medical devices: see sections 41MP, 41MPA, 41MQ and 41MR.