Description: Further to the MHRA consultation on the future regulation of medical devices and in-vitro diagnostic devices in the UK, the World Trade Organization (WTO) published, in July 2023, notification of the draft Post-Market Surveillance Requirements Statutory Instrument (PMS SI), providing interested stakeholders with early notice of the intended legislative changes related to Post-Market Surveillance (PMS) for medical devices in Great Britain. The objective of the new legislation is to introduce clearer PMS requirements that are risk proportionate, with improved regulatory oversight. It is expected to apply from June 2024.
If at first glance there appears to be close similarity between the UK and EU regulations, subtle different specific UK requirements mean that manufacturers will need to review and amend their PMS procedures already developed to handle the EU IVDR.
This session will go over the proposed legislative changes and outline the similarities and differences between IVDR and UK MDR from the post-market surveillance and vigilance aspects. It will also illustrate the implications for manufacturers selling products under IVDR and UK markets.
Learning Objectives:
Understand the new PMS requirements under the UK MDR 2002.
Identify similarities/differences between the new UK regulations and the IVDR to enable better monitoring
