Obtaining CE Mark for Medical Devices

QuailCRO offers a full range of consulting and contract services for the registration of medical devices Class I, II and III >

All submissions are according to Council Directives 90/385/EEC, 93/42/EEC and subsequent communications

Summary of medical devices classification guidance for initial identification of probable device class:

Non invasive devices - Rules 1, 2, 3 and 4
Invasive devices - Rules 5, 6, 7 and 8
Active devices - Rules 9, 10, 11 and 12
Special rules - Rules 13, 14, 15, 16, 17 and 18

Member States shall take all necessary steps to ensure that devices may be placed on market and put into service only if they do not compromise the safety and health of patients.