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VIGILANCE forms and annexes - May 2020 releases

May 01, 2020 - Changes in Manufacturer Incident Reporting

MIR rev. 7.2.1 release.

January 2020 "Help Text" (list of Annexes A to F codes) is still applicable,

but Annex G (components) has also been released from IMDRF website last May.

Starting January 01, 2020, the management of vigilance event made the use of a new form compulsory, which was so far MIR rev. 7.2.

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First revision of this form was released last May 2020 under the name of MIR 7.2.1..

The current version of the new MIR Form (version 7.2.1) and the associated helptext and XSD files can be found on the European Commission website at:https://ec.europa.eu/growth/sectors... (under MEDDEV guidance).

This revised MIR 7.2.1 form is available from DOCSROOM at https://ec.europa.eu/docsroom/docum...
But you will also find it here attached under PDF format.

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As EUDAMED has been delayed, some sections are still not yet available and either prefilled (with "unknown") or left blank (which means their filling is not mandatary).
It used to be the case for instance the case of section / Annex G,

but since last May, is now mainly solely the case of EUDAMED and other UDI information.

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January 2020 "HELP TEXT" has not yet been updated and its contents are still IDMRF codes regarding Annexes A to F.

Annexes or "HelpText" are available from https://ec.europa.eu/docsroom/docum...

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Finally, May news also concerns the release of contents of all annexes IMDRF codes, including this time ANNEX G - COMPONENTS.You will it and find them all again from IMDRF website published such as follows :Annex A: Medical Device Problem

Annex B: Cause Investigation - Type of Investigation

Annex C: Cause Investigation - Investigation Findings

Annex D: Cause Investigation – Investigation Conclusion

Annex E: Health Effects - Clinical Signs and Symptoms or Conditions

Annex F: Health Effects - Health Impact

Annex G: Medical Device Component

at http://www.imdrf.org/workitems/wi-a...

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So far, no changes for RECALL managements since last January,
with a new requirement made by French NCA, ANSM and specific to it,
- which is the sending of the FSN under two formats :
- one, in word format, not signed (to protect signatures as personal data when published on ANSM’s website) ;
- the second FSN, signed, for ANSM’s files.

Now, please be quite sure we will be here to help and shall be glad to !

Whatever questions you may have on these Vigilance topics.

Best regards,MME Team Members

  • MIR rev. 7.2.1 (PDF – 188.1 kb)

    Manufacturer Incident Report (MIR) forSerious Incidents (MDR/IVDR)and Incidents (AIMDD/MDD/IVDD)Reporting Template Version 7.2.1European Union Medical Devices Vigilance System

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