Starting January 01, 2020, the management of vigilance event made the use of a new form compulsory, which is so far MIR rev. 7.2.
And to use it, publishing was made too of an updated "Help Text" (list of Annexes A to F codes)
Starting January 01, 2020, the management of vigilance event made the use of a new form compulsory, which is so far MIR rev. 7.2.
As EUDAMED has been delayed, some sections are not yet available and are either prefilled (with "unknown") or left blank (filling is not mandatary). It is for instance the case of section / Annex G, but also of the EUDAMED and other UDI information.
Now, if these fields are not to worry us at the time being, what was quite new with this MIR form is the compulsory use of codes where we used wording.
An "HELP TEXT" has so been released too early January 2020 that contains them all, from Annex A to Annex F.
Here below are the links where you will find them on the web :
MIR rev 7.2 can be uploaded from https://ec.europa.eu/docsroom/docum...
If you read then a message like
_ “Please wait...
If this message is not eventually replaced by the proper contents of the document, your PDF viewer may not be able to display this type of document.
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Please then just try to register it under your desk and re-open it (save under... open under... ) : it should work that simply ! :)
Annexes or "HelpText" are available from https://ec.europa.eu/docsroom/docum...
It is an excel format document, that we are not able to publish here but shall be glad to send you upon simple request if you had any trouble uploading the file from this link.
So far, (May 2020), no changes are forecast for RECALL managements that you have not heard from since last year already.
But please be quite sure we will be here to help and shall be glad to, whatever questions you may have on these Vigilance topics.
Amitiés,
MME Team Members