Collection

Medical devices: guidance for manufacturers on vigilance

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

Published 26 January 2015
Last updated 17 August 2016 — see all updates

• From: Medicines and Healthcare products Regulatory Agency

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

Further guidance on producing and distributing effective field notice is available:

https://embed.topra.org/sites/default/files/regrapart/1/6632/topra_regrapp_apr18_producing_and_distributing_effective_field_safety_notices.pdf

Documents

1. Reporting adverse incidents: biological and mechanical surgical heart valves

   • 1 January 2014
   • Guidance

2. Reporting adverse incidents: coronary stents

   • 4 October 2016
   • Guidance

3. Reporting adverse incidents: intraocular lenses

   • 1 June 2009
   • Guidance

4. Reporting adverse incidents: breast implants

   • 1 October 2009
   • Guidance

5. Reporting adverse incidents: inferior vena cava filter (IVC)

   • 2 January 2014
   • Guidance

6. Reporting adverse incidents: joint replacement implants

   • 1 June 2008
   • Guidance

7. Reporting adverse incidents: neurostimulators

   • 1 June 2013
   • Guidance

8. Adverse incidents: cardiac ablation catheters

   • 7 March 2016
   • Guidance

9. Adverse incidents: in vitro diagnostic (IVD) blood glucose meters

   • 26 January 2015
   • Guidance

Published 26 January 2015
Last updated 17 August 2016 + show all updates

1. 17 August 2016 Link to European Commissions detailed guidance updated
2. 26 January 2015 First published.