[ARTICLE] Incident reporting until release of the EUDAMED Vigilance module
The EUDAMED Vigilance module will serve notably for the reporting of serious incidents involving medical devices. Until the EUDAMED Vigilance module is operational, manufacturers shall continue to report incidents directly to the relevant National Competent Authority(ies).
In December 2018, the European Commission published the new Manufacturer Incident Report (MIR) form for manufacturers to use in this process. The form introduced novel information requirements under the MDR 2017/745/EU / IVDR 2017/746/EU such as trending data based on relevant similar incidents, and also integrates the use of harmonized adverse event terminology and codes recommended by the International Medical Device Regulators Forum (IMDRF).
The information requirements for Incident reporting using the new MIR form are announced to be highly similar to those for the upcoming EUDAMED Vigilance module, and the latter will also integrate the use of IMDRF terminology to describe adverse events, their causes, and their consequences on users/patients.
The new MIR form has since been updated twice. The latest version, MIR version 7.2.1, became applicable from January 1st, 2020, for the reporting of Incidents under both the EU Directives and the Regulations for both medical devices and IVDs. These comprise incidents reportable under the AIMDD 90/385/EEC / MDD 93/42/EEC / IVDD 98/79/EC as defined in MEDDEV 2.12/1 Guidelines on a medical device vigilance system, and Serious Incidents under the MDR / IVDR. Accordingly, wherever the form refers to “incidents”, one should read “serious incident”, in other words reportable event, when the form is used to report under the MDR/IVDR.
A clarification has to be made regarding the difference between an Incident under the AIMDD/MDD/IVDD and a Serious Incident under the MDR/IVDR. These two terms mean the same thing, there is just a slight modification of the wording for the definition of Serious Incident as per the MDR/IVDR:
“Serious incident means any incident that directly or indirectly led, might have led or might lead to any of the following: the death of a patient, user or other person; the temporary or permanent serious deterioration of a patient’s, user’s or other person’s state of health; a serious public health threat”.
Hence, events that were reported as Incidents under the AIMDD/MDD/IVDD, are now considered as Serious Incidents under the MDR/IVDR. It shall be noted that the MDR/IVDR also define Incidents. However, under the Regulations, Incidents refers to degradation of the characteristics and performance of the device, including use error to ergonomic features as well as any inadequacy in the information supplied by the manufacturer and any undesirable side-effect, which only require to be reported if they also qualify a Serious Incidents.
It shall be emphasized that completing the different fields of the new MIR form is a complex and time-consuming task, particularly in comparison with what was previously required for incident reporting under the AIMDD/MDD/IVDD
The use of the new MIR form to report Incidents is mandatory since January 2020. It shall be emphasized that completing the different fields of the new MIR form is a complex and time-consuming task, particularly in comparison with what was previously required for incident reporting under the AIMDD/MDD/IVDD. Indeed, the main purpose of this new form is to have more complete information of the incidents and to be able to collect the data in a harmonized way.
The IMDRF terms and codes to be employed for filling in the MIR form can be found in the IMDRF Adverse Event Terminology web browser. The main tool provided by the EC to support manufacturers in the implementation of the MIR form is the New manufacturer incident report help text.
This living document clarifies which fields are mandatory or voluntary to complete in function of the different types of reports (initial, update, final, etc.) pertaining to the main Incident reporting stages, and moreover provides practical guidance on how to fill certain fields of the MIR form. It shall furthermore be noted that new MIR XSD and XSL files are available for implementation in manufacturers’ databases.
Medidee can offer support to manufacturers in completing and submitting the new MIR form, and, for manufacturers wishing to implement the MIR XSD and XSL files within their own databases, support in validation of the solution.
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This article was written by Dr Jérôme Randall.