Chapter - Medical Device Compliance - Post Market Requirements Flashcards
What is MEDDEV 2.12/1 Rev 8?
Guidelines on medical device vigilance system
What is MEDDEV 2.12/2 Rev 2?
Guidelines on PMCF, 2012
EUDAMED is
European ______ on ____ ____
2 standards which address postmarket surveillance
EN ISO 13485 and 14971
Two main feedback mechanism for medical devices
post market surveillance and FSCA ( Field Safety Corrective Action)
Definition of incident/ recall
See page 94
Criteria and procedures used by manufacturers, Competent Authorities and all other interested parties to notify and handle incidents and FSCAs or recalls are collectively known as
Medical Device Vigilance System
This directive is intended to ensure high consumer product safety, it competes, complements and reinforces the medical device vigilance provisions found in AIMDD, MDD and IVDD
2001/95/EC - General Product Safety Directive (- GPSD)
Post market surveillance procedures
page 95
Sources of information for PMS
page 95
What are the three critical concepts in all phases of the medical device’s life cycle
Risk assessment, analysis and management
_______ is a living document
Risk Management File is a living document
Residual risks of a device should be investigated and assessed in the postmarket phase through systematic ______ studies and it is part of the device’s PMS plan
PMCF
Examples of PMCF studies
page 96
PMCF is mandatory when CE marking is solely based on ___
clinical data from equivalent devices
