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Additional guidance released _ Vigilance

Vigilance reporting : Latest release to provide further guidance to the use of new MEDDEV forms to be used no later than Jan 01, 2020

Dear Partners and Vigilance teams members,

The EU commission recently released, early days of August 2019, Additional Guidance Regarding the Vigilance System : MEDDEV 2.12-1 rev 8 here attached.

This document provides additional guidance in relation the Vigilance System of reporting which will be compulsory used starting January 01, 2020 (even if partially usable right now for those for are already familiar with most updated topics of Vigilance issues).The guidance 2.12-1 rev.8 should complement and be used in conjunction with still current MEDDEV 2.12-1 (2013).

Amongst the changes :
- Clarification of some of the already existing définitions ;
- Introduction of this new MIR form and new templates for FSN ;
- Introduction of device-specific vigilance guidance ;
- Further detail in relation to the area of NCA’s coordination about vigilances issues ;
- Clarification of some différences existing between EU NCA reporting and IMDRF vigilance reporting

You’ll may find all the forms from this website in several articiles or directly from EU link (in our sections link).

We remain at your disposal for any other / further question you may have about these new forms, or advice about information which will have to provided to fill in Vigilance forms within sending.


Best regards,MediMark Europe Team

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