Published approval details

I recommend to approve Model Report application MRE-2022-0000302, I confirm: • that all relevant considerations, reasons, justifications and supporting material or inspection reports associated with the recommendation are available for the delegate to review • Model Report scope, work instructions and verification checklists have been assessed against eligibility criteria • all CI forms and supporting documentation of modified ADRs were assessed. • appropriate details about the records that must be kept have been addressed all RFIs have been resolved • all risk factors have been addressed • assessment notes have been made clearly stating the assessor is satisfied that the application and Model Report meet eligibility criteria • Policy confirmed “Standard” is the correct compliance level for “Rarity” and the non-applicability of ADRs as listed.