Violation of CE mark - Re-use of single-use Products

[Paul Tillkvist]

We have a competitor that offers single-use class IIB products used prior to and after an ABO-incompatible transplantation. It has been well known for the Company for years that one country, Switzerland, re-use the products. This is a violation of the CE mark. In this case, what is the responsiblity of the Company? Should they stop Selling the Products to the Swiss costumers? Can they act as they do not know what is going on with the re-use of single-use Products?

 

[Gisly]

If a national authority (regulatory body) of Switzerland has approved off-label-use (exception) then this should not a problem (?). Approval of off-label use is relatively common...

 

[J0anne]

We have a competitor that offers single-use class IIB products used prior to and after an ABO-incompatible transplantation. It has been well known for the Company for years that one country, Switzerland, re-use the products. This is a violation of the CE mark. In this case, what is the responsiblity of the Company? Should they stop Selling the Products to the Swiss costumers? Can they act as they do not know what is going on with the re-use of single-use Products?

Single use means the device has only been tested and validated for a single use by the manufacturer

If I wish to re-use a single use device, I must guarantee its safety and efficacy and I would also take on responsibility for the safety of the device