This session gives an overview of legislative requirements for GDC registrants who provide custom-made medical devices in the UK and the EU, including the Medical Devices (Post-Market Surveillance Requirements) (Amendment) Regulations 2024.

• State the roles that dental professionals can have in providing custom-made devices – Identify activities that are subject to custom-made medical device regulations – Describe why medical device regulations in Great Britain differ from those in Northern Ireland and the EU and compare the similarities and differences – Explain legislative requirements for custom-made device manufacturers.
• Explain legislative requirements for custom-made device manufacturers.