Dear Members and Partners,
You may find here attached several documents, amongst which the latest 2019 Revision of the MIR ( MANUFACTURER INCIDENT REPORT) following MEDDEV Guidelines.
Attached too are a "help text" provided with the MIR form by MEDDEV;and six annexes that will help understand what is expected in matter of reporting procedure, of course, but may also lead you to update your vigilance procedure.
This MIR Revision is not yet applicable and shouldn’t be withing next January 2020 (and even, not yet "fully" as most NCAs don’t/won’t have yet their own EUDAMED codes for instance).
But changes are so numerous and important that we thought the earliest you may have the information, the easiest it could be to manage when time comes to.
"Helptext" is a mere Guideline that may be helpful separating information required in the different five sections of the MIR Template (some of which you will recognize easily !)
Annexes shall be helpful using the brand new terms and definitions and moreover : the codes that will more or less replace the "text" sections we used to fill on former form(s).
Annex A is thus fully dedicated, in its three levels, to Term/Code/Definition.
Annex B is dedicated to the "Type of investigations", helping characterising them.
Annex C concerns "Investigations Findings" (what they are)
Annex D concerns "Investigations Conclusions" (why did the incident/adverse occur?)
Annexes E and F are dedicated to "Health Effects Terms and Codes".
Annex E is dedicated to "Clinical Signs, Symptoms and Conditions" with again a three-level system coding, with a structure according to Organ/Physiological system
Anned F determines a three-level system coding for "Health Impact" (e.g. death, hospitalization, unexpected medical intervention, wrong intervention due to incorrect diagnosis...)
Hoping all this will be helpful in organizing your own internal reporting and vigilance systems,
Friendly yours,
MediMark Europe Team
