When an FSCA is required
The criteria that require a manufacturer to initiate a Field Safety Corrective Action (FSCA) under the UK MDR 2002 — what constitutes an FSCA, how to decide if action is needed, and the relationship between FSCAs and vigilance reporting.
Field Safety Notices (FSNs)
What a Field Safety Notice must contain, how it should be distributed, MHRA review of FSN content, and the mandatory elements under the UK MDR 2002 and MHRA guidance.
Recalls — process & MHRA coordination
How a medical device recall is conducted in the UK — the types of recall action, working with MHRA, recall classifications, logistics, completion evidence, and post-recall follow-up.
MHRA-initiated safety actions
The powers MHRA can exercise to initiate safety actions independently of manufacturers — including suspension and prohibition notices, recall orders, public warnings, and enforcement under the UK MDR 2002.