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

Documents

  1. Directives bulletin 3: European vigilance system in the UK

    • Guidance

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

    • Guidance

  3. Reporting adverse incidents: coronary stents

    • Guidance

  4. Reporting adverse incidents: intraocular lenses

    • Guidance

  5. Reporting adverse incidents: breast implants

    • Guidance

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

    • Guidance

  7. Reporting adverse incidents: joint replacement implants

    • Guidance

  8. Reporting adverse incidents: neurostimulators

    • Guidance

  9. Adverse incidents: cardiac ablation catheters

    • Guidance

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

    • Guidance
Published:
Updated:

+ full page history

Link to European Commissions detailed guidance updated
First published.
From:
Medicines and Healthcare products Regulatory Agency