MEDDEV 2.12/1's new MIR & IMDRF terms & codes (IMDRF Annex)

Jean_B

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#1
I'm curious how fellow big and small MedTech complaints & vigilance units are (going to be) dealing with the requirement to report according to "IMDRF Medical device problem codes (Annex A)" and similar, as instructed in sections 3.2 a, 3.3 a, 4.2 e & f and 4.3.1 of the new Manufacturer Investigation Report.(DocsRoom - European Commission).

How far along is everybody with understanding and implementing the codes, and what kind of issues have you faced?

We ourselves must reconcile company/product specific failure codes (possibly for section 4.3.2) with this generic hierarchy, and are still deciding on whether to keep specific or only use the generalized ones, and how to store and link the data for trending over this break.
Besides this, there is a large amount of codes to be come acquainted with for the people dealing with them, which we envision to take some training. Is anyone aware of providers on this, or is every company expected to do the double work of creating, testing and running their own training programs on this generalized system?

Do you think you'll manage to implement by January 2020?
 
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