UK MHRA: Medical devices: guidance for manufacturers on vigilance
Information for manufacturers of medical devices about reporting adverse incidents and corrective actions to MHRA.
You must report adverse incidents with your medical device to the competent authority where the incident happened.
See the European Commission’s detailed guidance on what, how and when to report an adverse incident to MHRA.
You should also check our guidance below on what to report for certain types of devices.
Posted on the UK MHRA website on 26 January 2015