Vigilance System MEDDEV 2009 changes - MEDDEV 2.12-1 rev 6 for Vigilance System

T

Tiffany

#1
Dear Mates,

Have found the new revision of MEDDEV 2.12-1 rev 6 for Vigilance System.
Is there a major changes on this guidance? Or is there any particular section have been amended only?

Tiff...
 
Elsmar Forum Sponsor
Thread starter Similar threads Forum Replies Date
dgrainger Informational Additional Guidance Regarding the Vigilance System as outlined in MEDDEV 2.12-1 rev. 8 EU Medical Device Regulations 1
S Revised MEDDEV 2.12-1 rev 8 Vigilance System - Released EU Medical Device Regulations 3
bio_subbu EU publishes revised guidance on Medical Devices Vigilance system MEDDEV 2.12-1 Rev7 EU Medical Device Regulations 8
M Informational DSVG 04 – Breast Implants – Guidance on the vigilance system for CE-marked medical devices Medical Device and FDA Regulations and Standards News 0
M Informational EU – DSVG 03 – Cardiac Implantable Electronic Devices (CIED) – Guidance on the vigilance system for CE-marked medical devices Medical Device and FDA Regulations and Standards News 0
R Medical Device Vigilance System Requirements - CE Mark Products EU Medical Device Regulations 4
O Vigilance System - Seeking example Procedure and Implementation Advice ISO 13485:2016 - Medical Device Quality Management Systems 4
M Vigilance - incident found in an article EU Medical Device Regulations 3
R Vigilance reporting to the country of the EU authorised representative EU Medical Device Regulations 2
A Medical Device Vigilance decision tree for Japan for class 2 devices. Japan Medical Device Regulations 1
L Global distributor vigilance responsibility Medical Device and FDA Regulations and Standards News 14
M Saudi Arabia (KSA) - Medical Device Vigilance according to 93/42/CEE Other Medical Device Regulations World-Wide 0
K Vigilance process flow chart EU Medical Device Regulations 1
M Informational MHRA update – Medical devices: guidance for manufacturers on vigilance - June 2019 Medical Device and FDA Regulations and Standards News 0
W SOP for Vigilance reporting covering multiple requirements Document Control Systems, Procedures, Forms and Templates 3
F Vigilance Reporting - Requirements for manufacturer Field Corrective Actions (FCAs) Other Medical Device Regulations World-Wide 5
J Medical Device Vigilance decision tree FORM - Please share yours EU Medical Device Regulations 15
M Definition Vigilance - What is the definition of "Vigilance"? Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 5
S Understanding PMS (Post Market Surveillance) and PMCF (Vigilance and PMCF) Quality Manager and Management Related Issues 1
S Help with EU Medical Device Vigilance Reporting Requirements EU Medical Device Regulations 0
J Can I combine Recalls, Advisory notices, and Vigilance systems into one procedure? ISO 13485:2016 - Medical Device Quality Management Systems 2
A Japan Medical Devices Vigilance Regulations or Guidelines Japan Medical Device Regulations 4
D Vigilance Trend reporting requirements of Meddev 2.12/ver 7 in the EU Document Control Systems, Procedures, Forms and Templates 1
A Flowchart to explain the Medical Device Vigilance Reporting Process wanted EU Medical Device Regulations 4
T EU Medical Device Vigilance Reporting Requirements EU Medical Device Regulations 3
K Vigilance, MDR, Recall, Complaint Procedures - Can this all be one single procedure ISO 13485:2016 - Medical Device Quality Management Systems 3
P Good Vigilance Practice (GVP) - Japan - English translation and explanation of Japan Medical Device Regulations 8
I Vigilance SOP that covers Australia, Taiwan, Japan or Brazil wanted Other Medical Device Regulations World-Wide 1
P Medical Device Vigilance - MDR or MDD? EU Medical Device Regulations 9
B Medical Device Vigilance Reporting Multi Markets Other ISO and International Standards and European Regulations 2
V Evidence for Preventive Action & Early Warning Vigilance procedure Preventive Action and Continuous Improvement 4
bio_subbu MHRA - Draft guidance on specific device vigilance reporting EU Medical Device Regulations 0
D Vigilance - Public database of Vigilance reports (similar to FDA MAUDE database)? Other Medical Device and Orthopedic Related Topics 1
J Vigilance Report Required for Incidents Outside the EU? EU Medical Device Regulations 2
J EU Vigilance (updated MEDDEV rev.5) - Internal Forms EU Medical Device Regulations 13
E How to practically organize the 'Vigilance' function? ISO 13485:2016 - Medical Device Quality Management Systems 7
J Distributor Requirements - Vigilance and Traceability ISO 13485:2016 - Medical Device Quality Management Systems 7
D Official Government Regulatory Body Vigilance Contacts to use for China and for India ISO 13485:2016 - Medical Device Quality Management Systems 4
C Audit NonConformance - Evidence of Post Market Vigilance and Product Recall. ISO 13485:2016 - Medical Device Quality Management Systems 6
Z MEDDEV 2.12-1 Rev 5 Reportability Decision Tree? Vigilance Reporting Procedure EU Medical Device Regulations 18
O Medical Device (MedDev) Vigilance Guidelines for Importers into the UE EU Medical Device Regulations 5
J Medical Devices Vigilance Procedure Example needed Document Control Systems, Procedures, Forms and Templates 12
U Regulatory Contacts in every country for Medical Device Vigilance purposes ISO 13485:2016 - Medical Device Quality Management Systems 3
A Who is in charge of Vigilance reporting in your company? ISO 13485:2016 - Medical Device Quality Management Systems 1
T Device & Accessory, Components in device, or System EU Medical Device Regulations 0
M Go Live With New ERP System before Recertification Audit General Auditing Discussions 6
John C. Abnet Terms- Different Items in a system ISO 26262 - Road vehicles – Functional safety 0
T Controlling Expandable Forms in Paper-Based Document Control System Document Control Systems, Procedures, Forms and Templates 10
G Management Review (integrated system) Management Review Meetings and related Processes 17
M Unique Quality Management System for 2 sites ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5

Similar threads

Top Bottom