For manufacturers reporting adverse incidents with cardiac ablation catheters under the European vigilance system.
MHRA’s guidance on when to report adverse incidents with cardiac ablation catheters was superseded by the European Commission’s guidance in November 2014.
You need to read this alongside the European Commission’s guidelines on the vigilance system for medical devices.
Don’t include personal or financial information like your National Insurance number or credit card details.
To help us improve GOV.UK, we’d like to know more about your visit today. We’ll send you a link to a feedback form. It will take only 2 minutes to fill in. Don’t worry we won’t send you spam or share your email address with anyone.