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2019-07-11 Updated EU Vigilance general guidelines

Additional Guidance Regarding the Vigilance System as outlined in MEDDEV 2.12-1 rev. 8

Dear Partners,

- Our previous publishing of the 2018 FSCA forms (FSN - general ; FSN forms for Distributors (as with FDA) ; FSN forms dedicated especially to End Users (wether professional or totally "Profane" users) might have already come to your attention ;

- As well as our publishing concerning the two revised forms for MIR (Manufacturer Incident Report) ;
- 1/ one kind of "hybrid" revision being aldeady current (making so the sole use of annexes A to D compulsory to fill it) -
- (now it seems EU-NCAs still accept former Meddev form (ie : totally "worded" reports).
- 2/ the other to be used no later than next January 2020 - this time totally "coded" following indications - and so "figures" to be extracted from annexes A to F references.



As a mere explanation, the attached "Additional Guidance MEDDEV 2-12-1 Final", recently published by EU COM, provides general guidelines about the forms they’ill expect us all to use.


From its table of content, you may thus read/learn more about what is expected from us ; and thus n more generally plan possible internal (re)organization that will enable us all to provide all information that will be required, furthemore in delays soon shortened by the MDR (from maximum 1 / 3 to 15 days after event occured, depending on its severity):

Table of Contents
- 1. INTRODUCTION
- 2. DEFINITIONS - page 4
- 2.1. FIELD SAFETY CORRECTIVE ACTION (FSCA) - page 4
- 2.2. FIELD SAFETY NOTICE (FSN) - page 5
- 3. DEVICE SPECIFIC VIGILANCE GUIDANCE - page 6
- 4. MANUFACTURER’S INCIDENT REPORT - page 7
- 5. FIELD SAFETY CORRECTIVE ACTION - page 8
- 6. CONTENT OF THE FIELD SAFETY NOTICE - page 9
- 7. CIRCUMSTANCES WHERE A COORDINATING NATIONAL COMPETENTAUTHORITY IS NEEDED - page 10
- 7.1 SINGLE COORDINATING NATIONAL COMPETENT AUTHORITY - page 10
- 7.2 VIGILANCE TASKFORCE - page 10
- 7.3 THE ROLE OF A VIGILANCE TASKFORCE- page 11
- 8. DISSEMINATION OF INFORMATION BETWEEN NATIONAL COMPETENTAUTHORITIES - page 12
- 8.1 The Format of the Exchange - page 13
- 9. IMDRF NCAR EXCHANGE - page 14
- 10. MEDDEV 2.12-1 rev. 8 – Forms - page 15

Reporting forms are so already available from our website (dedicated articles in "Members Area").
_

You may also refind them all from the link to EU COM you’ll find in section "link".


And we of course remain at your entire disposal for working on these requirements with your Vigilance teams !!!!!!!!!!!!!

Or any question you may have about which we’ll be happy to help the best we can !


With our Best regards,

Christine & René

EU HQ - MME Team

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