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A new version of the Manufacturer Incident report (v7.2) was published as communicated in our newsflash dated September 30, 2019
The European Commission has posted on their website a new template for a Manufacturer Incident Report (MIR), along with a help text on how to complete the new form. The new template can be used as of January 1st 2019 for incidents under the MDD/AIMDD or IVDD, or for serious incidents under the MDR or IVDR.
The new Manufacturer Incident Report (MIR) template is significantly more elaborate. The new MIR consist of 5 sections.
Section 1
Requires the submitter to provide the relevant administrative information such as i.a. details of the national competent authority, manufacturer and authorised representative details but also information regarding the date of the incident and the manufacturer awareness date.
Section 2
Requires the submitter to provide the relevant medical device information, such as i.a. UDI, nomenclature, device catalogue number, lot number, risk class and accessories or associated devices.
Section 3
Requires the submitter to provide specific incident information such as i.a. the nature of the incident, IMDRF Medical Device problem code (Annex A) and IMDRF “Health Effect” terms and codes (Annex E and F). Note that the IMDRF terminologies for categorized Adverse Event Reporting (AER) Annex E and F are not yet published.
Section 4
Requires the submitter to provide the manufacturer’s analysis, including the cause investigation and conclusion as well as the respective IMDRF “Cause Investigation” terms and codes (Annex B, C and D) and the IMDRF Component Codes (Annex G). Note that the IMDRF AER Annex G is not yet published.
Section 5
Allows for additional comments to be provided.
Section 3
Requires the submitter to provide specific incident information such as i.a. the nature of the incident, IMDRF Medical Device problem code (Annex A) and IMDRF “Health Effect” terms and codes (Annex E and F). Note that the IMDRF terminologies for categorized Adverse Event Reporting (AER) Annex E and F are not yet published.
Section 4
Requires the submitter to provide the manufacturer’s analysis, including the cause investigation and conclusion as well as the respective IMDRF “Cause Investigation” terms and codes (Annex B, C and D) and the IMDRF Component Codes (Annex G). Note that the IMDRF AER Annex G is not yet published.
Section 5
Allows for additional comments to be provided.
At the end of the document a coded summary of the report, based on the IMDRF AER codes, is auto populated.
For each individual device suspected to be involved in an incident or serious incident a separate MIR must be completed.
The help text provides guidance on how to fill in the MIR and what type of information is to be added in each section.
The European Commission has also provided XSD formats of the various types of forms to allow users to implement the new forms into their systems.
What does this mean to you?
The new MIR form can be used as of January 1st 2019. A 12-month transition period is foreseen before the new form becomes mandatory January 1st 2020, until that day you can continue to use the current “old” MIR form. As a company it is vital that you start setting up your systems to allow completion of the elaborated form, including the introduction of the IMDRF AER codes into your systems.
Contact us if you require in-depth information, training or support.
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