Yellow Card: Report a problem with a medicine or medical device
MHRA maintains Yellow Card reporting system for adverse events related to medical devices. This is part of the regulatory framework for post-market safety surveillance of medical devices in the UK.
Manufacturers and sponsors placing medical devices on the the UK market should review their current compliance documentation against this change. Assess whether your device class, labelling, registration status, or technical documentation is affected. Where gaps are identified, update your files and notify your local representative or importer. Refer to the official source below for the full regulatory text and any transitional arrangements.
View official source ↗