Reporting Medical Device Adverse Events Uk

Report a problem with a medicine or medical device

https://www.gov.uk/report-problem-medicine-medical-device

Report a suspected problem (‘adverse incident’) with a medicine or medical device using the Yellow Card Scheme as soon as possible, for example if: a medicine causes side effects someone’s...

Medical devices: guidance for manufacturers on …

https://www.gov.uk/government/collections/medical-devices-guidance-for-manufacturers-on-vigilance

Yellow Card | Making medicines and medical devices safer

https://yellowcard.mhra.gov.uk/

Reporting as a manufacturer, marketing authorisation holder or other non-patient or health professional for a medical device adverse incident, fake or defective healthcare …

Medical device adverse incidents | Making medicines …

https://yellowcard.mhra.gov.uk/medicaldevices

Specific reporting routes for adverse medical device incidents by healthcare professionals in the UK. Adverse incidents involving medical devices in England and Wales should be …

Notify the MHRA about a clinical investigation for a …

https://www.gov.uk/guidance/notify-mhra-about-a-clinical-investigation-for-a-medical-device

The following serious adverse events involving a device under clinical investigation within Northern Ireland should be reported to the MHRA: (a) any serious …

Reporting adverse drug reactions medical device …

https://www.gmc-uk.org/ethical-guidance/ethical-guidance-for-doctors/good-practice-in-prescribing-and-managing-medicines-and-devices/reporting-adverse-drug-reactions-medical-device-incidents-and-other-patient-safety-incidents

Reporting adverse drug reactions medical device incidents and other patient safety incidents. Published 5 April 2021. Next. Content. 86. Early, routine reporting of …

Regulating medical devices in the UK - GOV.UK

https://www.gov.uk/guidance/regulating-medical-devices-in-the-uk

As noted above, to place a device on the Great Britain market (England, Wales and Scotland), manufacturers based outside the UK are required to appoint a UK …

EU Medical Device Vigilance Reporting in Europe - Emergo

https://www.emergobyul.com/services/medical-device-vigilance-and-incident-reporting-europe

The reporting timelines are as follows: Serious public health threat – immediately and not later than two days after the manufacturer becomes aware of the threat. Death or an …

Suspect an adverse reaction? Yellow Card it! - GOV.UK

https://www.gov.uk/drug-safety-update/suspect-an-adverse-reaction-yellow-card-it

You can report Yellow Cards for all medicines, medical device adverse incidents, defective medicines, counterfeit or fake medicines or medical devices, and …

Medical Device Reporting (MDR): How to Report Medical …

https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems

The Medical Device Reporting (MDR) regulation ( 21 CFR Part 803) contains mandatory requirements for manufacturers, importers, and device user facilities to report certain …