As promised by the MHRA, the Post Market Survailence Statutory Instrument 2024 No. 1368 modifying the UK MDR 2002 (as amended), has been published 16th December 2024, and there for applies for all IVD’s placed on the GB market from 16th June 2025.
If you’ve not already started preparing your Quality Management systems for the update, now the time to start, as the June deadline will roll round very quickly.
As previously discussed at the UKCA Sub Group and Regulatory Working Parties there are a number of key differences from the EU PMS requirements. Including different definitions, prescribed timelines and prescribed content compared with the EU requirements. This means that compliance with UK requirements is not a simple cut and paste of your EU PMS plans and reports.
