Guidance on clinical evidence requirements for medical devices: Amending licence applications

Date published: November 15, 2022

When the subject device is modified from a previously licensed device, manufacturers should clearly indicate how the subject device has been modified since the original evaluation of the device's clinical data. Manufacturers should also clearly outline whether the changes have introduced any new or modified safety and/or effectiveness risks. If warranted, additional literature reports and/or device-specific investigations should be provided.

To help determine if it's necessary to generate additional clinical data, manufacturers may perform a gap analysis on the existing clinical evidence. Give special attention to the following items:

• new design features, including new materials
• new software or software revisions
• new inputs
• new intended purposes, including new medical indications, new target populations (for example, age, sex, gender)
• different types of users (home use versus in hospital)
• different user profiles (for example, sex, race and ethnicity, gender or different age groups)
• new hazards or changes to the probability of occurrence of hazardous situations
• patient contact
• increasing duration of use or numbers of re-applications
• any other aspect where the pre-clinical testing data may not be sufficient to draw a conclusion on safety or effectiveness

For information on what changes to a licensed Class III or IV medical device are considered significant, please refer to the Guidance for the interpretation of significant change of a medical device.

Device comparison methods provided instead of device-specific clinical data may be sufficient if comparative non-clinical testing can address the safety and effectiveness of the subject device. Comparative non-clinical testing includes directly comparative bench tests and/or pre-clinical studies.