New MIR form* - as from January 2020
New manufacturer incident report (PDF form)
New manufacturer incident report for importing XML file* with Adobe
Professional
The published MIR form is password-protected so it may be necessary to
unlock it for specific purposes (e.g. translating the form, implementing it
into in-house IT systems).
You can request the password for specific authorised uses, which are
subject to terms and conditions.
New manufacturer incident report XSD file and XSL files (for
implementation in manufacturer’ databases)
New manufacturer incident report help text
Changelog file
Questions and answers document on the implementation of the new MIR
form
*If you're a manufacturer and have already adapted your IT system to
version 7.2, you may use this version until the end of March 2020.
Please note: Some browser plugins are not compatible with PDF forms. If
you have problems opening these forms, please save them to your
computer and open them from there.
Other forms and templates
Field safety corrective action - FSCA (1 MB)
FSCA xml files
Field safety notice template (105 kB)
FSN customer reply (108 kB)
FSN distributor/importer reply (103 kB)
FSN Q&A (152 kB)
Trend report (151 kB)
Periodic summary report (192 kB)
Ⅱ. Device specific vigilance guidance
DSVG Template
DSVG 00 Introduction to device specific vigilance guidance
DSVG 01 Cardiac ablation vigilance reporting guidance
DSVG 02 Coronary stents vigilance reporting guidance
DSVG 03 Cardiac implantable electronic devices (CIED)
DSVG 04 Breast implants
DSVG 05 Insulin Infusion Pumps and Integrated meter systems
MEDDEV 2.12/2 rev.2 (228 kB) Post market clinical follow-up studies
January 2012