You say the new EU MIR form. The latest version I can find is 7.2.1.
The information must come from the manufacturer. There is no external database.
The expectation is that the manufacturer has all the records. When completing section 4.3.3 the manufacturer needs to count all the similar incident reports filed around the world. This is the numerator. Most companies use "Model" as the basis for similarity. The numerator is the number of incidents per model in the time period.
For the denominator most companies use "Units distributed within each time period". This is the number of shipments by model. Since the UDI-DI encodes the model, be sure you are consistent in the analysis. You will also need to identify the country to which you shipped the model. Also identify whether the country is EEA, CH, or TR.
When you get to 4.3.3.c you will have the required data.
For my clients, I recommend keeping the information in an Excel workbook. Use various Excel functions to count the entries. Keep one workbook for each year and update it once a month.
It is a lot of work to start, since if were to file an MIR this year, you would need to build workbooks for 2023, 2022, 2021, and 2020. Once you have them, keeping them current is a simple maintenance task.
As an aside, the regulators will use the information in this section to calculate rates, numerator/denominator. If the rates exceed some threshold determined by the Competent Authority, that could trigger market surveillance.
You should also be calculating the rates with each monthly update. If you are not seeing a downward trend, this is a signal that you may need to review the effectiveness of your complaint system and your post-market surveillance system.
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Dan O'Leary CQA, CQE
Swanzey NH
United States
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Original Message:
Sent: 27-Aug-2023 01:06
From: Benjamin Kitchens
Subject: EU MIR Form 4.3.3