Report incidents and field safety corrective actions
As a manufacturer or supplier of medical devices you have the legal obligation to report incidents to the Inspectorate which involved devices which you make or deliver. You must also inform the Inspectorate of corrective measures relating to the safety of medical devices, for example if you recall products.
If your product has been involved in an incident you must report this to the Inspectorate. For more information about reporting incidents involving medical devices, please consult section 2.12 of the European guidelines.
From January 2019 a new European Manufacturer Incident Report (MIR) form is available for manufacturers and European representatives to report incidents with medical devices and in vitro diagnostics. This new MIR-form has been developed in cooperation with European member states and manufacturers.
NOTICE: After you have filled in this MIR-form, please click on the button 'Submit XML by Email' and supplementary, add the complete MIR form as a PDF file to this email. It’s possible to add other attachments that might be relevant for the submitted report.
You can send your email to: firstname.lastname@example.org. Please add 'Your reference number: | our reference number' in the subject line of the email.
Reporting a corrective action (FSCA)
If you take action to rectify a defect or fault on one of your products, you must report this to the Inspectorate. Examples are general recalls, or changes to the design, instructions for use or packaging of the product. For more information about reporting corrective actions involving medical devices, please consult the relevant European guidelines.
You can report corrective actions using a standard form. Fill in the digital form and save it. Then add the form as an attachment to an e-mail message. You can also add other attachments which are important for the report. Send the e-mail to: email@example.com. A clarification of the form is also available on the European Commission website.
What happens with my report?
Your report will be confirmed in writing. After that an assessment will take place as to whether the incident or the corrective action constitutes a risk for patient safety. The Inspectorate assesses whether further research is required on the basis of your report.
The importance of a good report
On the basis of the information you supply, the Inspectorate will assess the risk and start an investigation as necessary. It is therefore important that you describe the incident as comprehensively as possible and in understandable language. You should also show that you have obtained information from the care provider or other parties involved. You should define the root cause and consequence of the incident. Check the root cause against the risk analysis of your product and provide arguments as to whether it falls within the applicable limiting values. Provide evidence of which preventive and/or corrective actions you are taking to prevent comparable incidents.