MDES Adverse Event Reporting
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The following page provides guidance on the reporting of Medical Device - Reporting adverse events, incidents, and device deficiencies and Estates Safety - Reporting Defects and Failures.
Medical Devices – Healthcare Professionals
If you are a healthcare professional working within Northern Ireland, you should consult your organisations policies and procedures on reporting to the MHRA Yellow Card scheme. Further guidance can be found in the linked document.
Medical Devices – General Public and Patients
If you are a member of the public or a patient who has experienced a problem when using a medical device or a complication/adverse event with a medical device, you should report this directly to the MHRA Yellow Card scheme by following this link.
Estates Defects and Failures
Guidance on the type of Estates and Facilities defects and failures that should be reported to the MDES can be found in the Linked document. If the defect and failure meets the required criteria it should be reported on the appropriate MDES Defect and Failure form, a copy can be found here.
Enquiries concerning the content of any of these documents should be addressed to: mailto:mdes@health-ni.gov.uk