EU Manufacturing Incident Report (MIR) version 7.3

#1
I have a few questions regarding the EU MIR version 7.3.
  • Does anyone know when it will be released?
  • Is there a 6-month implementation timeline?
  • Is there XSD information available on the changes?
 
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debbie gallagher

Starting to get Involved
#5
As far as I am aware it is due to be released sometime later in 2022 (bit vague I know), the European Commission had initially said a 6 month implementation period, but MedTech Europe had requested that be changed to 12 months.

MedTech Europe deems the 6-month implementation timeline as insufficient as our members will not be able to adapt their software systems and processes in such a short period of time. Competent Authorities may face the same challenges with their national databases. Therefore, we recommend a 12-month implementation period as was the case for previous version of the MIR form.
 

debbie gallagher

Starting to get Involved
#9
Latest update from MedTech Europe:
Is it anticipated that MIR Form 7.3 will change prior its mandatory use (Q2, 2023 – when EUDAMED Vigilance module is operational)
No publication date yet. No feedback on the transition timeline yet.
 
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