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Version of MEDDEV Manufacturer's Incident Report Form for Argus 8.1.2 and Argus 8.2 (Doc ID 2523137.1)

Last updated on AUGUST 15, 2019

Applies to:

Oracle Argus Safety - Version 8.1.2 and later
Information in this document applies to any platform.

Goal

1. According to the European Commission (EC), there is a new MEDDEV Manufacturer's Incident Report (MIR) form (version 7) from January 2019. 

https://ec.europa.eu/growth/sectors/medical-devices/current-directives/guidance_en

Expand Guidance MEDDEVs
scroll down to section '2.12 Post-Market surveillance'
click on 'New Manufacturer Incident Report (from 1 January 2019)'
the downloaded form, mir_form_v7.1.pdf, contains 'Reporting Template Version 7.1'

However, the MIR report provided in Argus 8.1.2 and Argus 8.2 is version MEDDEV 2.12/1 rev 8.  Why is this?

 

2. The EC indicates the guidance for MEDDEV beginning with the new form in January 2019 and the obligation to have it in place by 2020.  When will this be implemented in Argus Safety?

https://ec.europa.eu/growth/sectors/medical-devices/current-directives/guidance_en

Expand Guidance MEDDEVs
scroll down to section '2.12 Post-Market surveillance'
which contains 'New Manufacturer Incident Report (for implementation in manufacturers databases before January 2020)'
 

Solution

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In this Document
Goal
Solution


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