Dear Members and Partners,
You may find here attached new forms and templates from Meddev guidelines to be used in case you’d have to start and manage a FSCA in Europe.
These forms shall be used starting 2019.
We would like to draw your attention of the fact that FSN designed for Distributors are now clearly to be distinguished from FSN designed for your End Users.
This is why we hope you’ll appreciate to find here enclosed the following documents published by Meddev and rearranged by MME teams :1- 2018-November New FSN Importer & Distributor Reply2- 2018-November New FSN Template Rev 13- 2018-November New FSN User Reply4- 2019-01-24 Questions and Answers to fill in the Field Safety Notice (FSN)5- 2018-September FAQ New FSN
All these are original documents you may re-find following the link :https://ec.europa.eu/growth/sectors...Section : 2.12 Post-Market surveillance Sub-Section : Ⅰ. MEDDEV 2.12/1 rev.8 – Latest Version Forms
Active PDF formsHow to use FSCA and MIR forms (12 kB)
Other forms and templatesField Safety Notice Template (195 kB)FSN Customer reply (108 kB)FSN Distributor/Importer reply (103 kB)FSN Q&A (152 kB)
We are also attaching forms redone under word format.
OP2-P6 FSN FORM Template _ REV SEPTEMBER 2018
OP2-P6 FSN USER REPLY Template _ REV.1 JULY 2018
OP2-P6 FSN DISTRIBUTOR-IMPORTER REPLY FORM_ November 2018
(Despite these changes, you may notice MEDDEV 2.12 rev. 7 FSCA is still valid (on March 02, 2019).
Again, we would like to stress on the fact EU is really aiming to distinguish FSN to be distributed to your Distributors / Importers from FSN to be distributed to your End Users.
It could be a difference that makes a change from the FDA reporting (mostly directed to distributors).
We remain at your disposal for any question you may have, simply hoping information and documents will be of the best help to you.
With our best regards,MME teams
