Our external engagement on the programme of regulatory changes for medical devices has re-started in earnest this week following the pre-election period and early discussions with new ministers. Bilateral meetings with Trade Associations have begun again, we are speaking at a number of conferences, and this week I am really looking forward to attending a patient engagement forum led by the Patient Safety Commissioner. This blog seems to be a useful way of reaching people, so I am pleased to be starting this up again too.
So where are we? Overall, the ‘shape’ of the roadmap we published in January 2024 remains the same, but some of the detail and timings will be slightly different. It remains the plan to bring our Medical Devices 2002 regulations up to date through a series of statutory instruments (SI), beginning with one that sets out clearer rules for Post Market Surveillance (PMS)…
