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Hello,
Based on MEDDEV 2.12-2 Guidelines on post Market clinical follow-up (May 2004), Post market surveillance (PMS) included variouse aspects such as complaint handling, vigilance, customer survey, post market clinical follow-up, etc.
In the recent revision (MEDDEV 2.12/2 rev2) published on January 2012, post-market clinical follow-up STUDIES have been explained, which will be used to update the clinical evaluation report periodically without any mentioning of customer feedback, etc.
1. Is there any other guideline that currently explains the PMS plan strategies/procedures?
2. Does it mean that clinical evaluaion report alone is enough to adress post market surveillance reporting, or a post market serveillance reprt is separetely needed? It seems to me that they both cover the same thing..
Based on MEDDEV 2.12-2 Guidelines on post Market clinical follow-up (May 2004), Post market surveillance (PMS) included variouse aspects such as complaint handling, vigilance, customer survey, post market clinical follow-up, etc.
In the recent revision (MEDDEV 2.12/2 rev2) published on January 2012, post-market clinical follow-up STUDIES have been explained, which will be used to update the clinical evaluation report periodically without any mentioning of customer feedback, etc.
1. Is there any other guideline that currently explains the PMS plan strategies/procedures?
2. Does it mean that clinical evaluaion report alone is enough to adress post market surveillance reporting, or a post market serveillance reprt is separetely needed? It seems to me that they both cover the same thing..