Medicines, medical devices and blood regulation and safety – collection

Medical devices: guidance for manufacturers on vigilance

Information for manufacturers of medical devices about reporting adverse incidents and corrective actions to MHRA.

Contents

  1. Documents

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.

Report adverse incidents via MORE or with the active PDF forms listed in section 2.12 market surveillance under Guidance MEDDEVs.

See the field safety notice (FSN) flyer to send alongside your FSN explaining what they are and why they are important to act on.

To get better response rates to your FSNs use the Medical Devices Safety Officer (MDSO) network. You can access this if you sign up to Manufacturers’ Online Reporting Environment