This lecture provides an overview of United Kingdom and European Union legislation for custom-made medical devices and examines new requirements that are expected to be introduced following the Government response to the consultation on the future regulation of medical devices in the United Kingdom.

• Describe the roles that GDC registrants can have in providing custom-made devices
• Explain which of these roles are subject to medical device legislation
• Compare the custom-made device regulations for Great Britain with those for Northern Ireland and the EU
• Identify the new requirements for custom-made devices that the UK Government plans to introduce, following their response to a consultation