Defining joint replacement medical devices and ancillary medical devices

This is guidance for manufacturers and sponsors on regulatory amendments defining shoulder, hip and knee joint replacement medical devices and ancillary medical devices.

These amendments came into effect on 20 April 2015, to clarify the appropriate classification for various medical devices supplied and used in shoulder, hip and knee joint replacements.

This guidance is provided in three sections:

• Definitions
  Outlines the meaning and provides links to the full text of the definitions
• Examples of applying the definitions
  Includes examples of how the definition applies to particular devices to illustrate the operation of these definitions
• Further reading
  Provides background on the reclassification of joint replacements and how the need for these definitions arose