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 and also read the additional guidance 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.
New regulations
Be aware that two new EU Regulations entered into force on 25 May 2017, namely:
- Regulation 2017/745 on medical devices (EU MDR)
- Regulation 2017/746 on in vitro diagnostic medical devices (EU IVDR)
The EU MDR and EU IVDR will fully apply in EU Member States from 26 May 2021 and 2022 respectively, but devices can already be placed on the market under these new regulations (if they fully comply with the new regulations).
The new regulations strengthen the vigilance and post-market surveillance requirements for manufacturers.
Changes affecting what needs to be reported to MHRA and when to do it include tighter timescales for manufacturers to report adverse events, the introduction of periodic summary update reports (PSUR) and widening the definition of a medical device to bring more products under scrutiny.
There is guidance on the MDR and IVDR for manufacturers of medical devices and IVDs online.
Both the FSN and MIR forms have been updated and are applicable under the current directives and the forthcoming MDR/IVDR regulations.
Documents
- Reporting adverse incidents: cardiac implantable electronic devices (CIEDs)
- Effective field safety notices (FSNs): guidance for manufacturers of medical devices
- Reporting adverse incidents: biological and mechanical surgical heart valves
- Reporting adverse incidents: coronary stents
- Reporting adverse incidents: intraocular lenses
- Reporting adverse incidents: breast implants
- Reporting adverse incidents: inferior vena cava filter (IVC)
- Reporting adverse incidents: joint replacement implants
- Reporting adverse incidents: neurostimulators
- Adverse incidents: cardiac ablation catheters
- Adverse incidents: in vitro diagnostic (IVD) blood glucose meters
Last updated 6 August 2020 + show all updates
-
New document for European Commission's guidance on reporting incidents with cardiac implantable electronic devices
-
Added a new document - Effective field safety notices (FSNs): guidance for manufacturers of medical devices
-
New information about upcoming MDR and IVDR regulations added to the page.
-
Added a link to new guidance on medical devices regulation in a no deal scenario.
-
Further guidance on producing and distributing effective field safety notices has been added.
-
Link to European Commissions detailed guidance updated
-
First published.