Distributors Responsibilities - Medical Device Recalls

JoCam

Trusted Information Resource
#1
Hi All,

I'm looking for clarification of the definition for Field Safety Notice in MEDDEV 2.12-1, which is written as 'A communication to customers and/or USERs sent out by a MANUFACTURER or its representative in relation to a Field Safety Corrective Action'.

Does this mean that a manufacturer that utilises distributors to sell, service and maintain their products in European countries must send out the FSN directly to the distributors customers, or should this task be performed by the distributor?

Your assistance will be very much appreciated as numerous searches have failed to offer up any suggestions and the MHRA are neither answering their phone nor responding to emails.

Jo
 
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shimonv

Trusted Information Resource
#2
Hello Jo,
MEDDEV 2 12-1 rev. 8 says:
"4.7 FIELD SAFETY NOTICE (FSN)
A communication to customers and/or USERs sent out by a MANUFACTURER or its representative in relation to a Field Safety Corrective Action."

I believe the regulator only cares that the FSN will go out. By whom is determined in the quality agreement between the manufacturer and it's distributors.

Shimon
 
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