RichardJ_CH
Registered
Dear MDSAP experts
Can someone please explain to me the impact of an MDSAP certificate with all countries coverage?
I can identify the following 3 scenarios under the assumption that I have a full MDSAP certificate (all countries) obtained in the EU.
1) if I want to sell my product outside of the MDSAP countries (e.g. China), I need to also satisfy the destination requirements
2) if I want to sell my product inside of the MDSAP countries (e.g. Canada), my product fits the requirements listed for the MDSAP certification, and I satisfy those having a MDSAP certificate, I can sell in any of the MDSAP countries without restrictions
3) if I want to sell my product inside of the MDSAP countries (e.g. Canada), but my product doesn't fit the requirements listed for the MDSAP certification (e.g. electronic IFU), then I can sell my product in any of the MDSAP countries without restrictions
-- as long as I meet my local EU (MDR) requirements on eIFU OR
-- if I meet the destination requirements on eIFU (in which case the idea of an MDSAP certificate covering all participating markets without restriction is lost).
Your input is highly appreciated,
Richard
Can someone please explain to me the impact of an MDSAP certificate with all countries coverage?
I can identify the following 3 scenarios under the assumption that I have a full MDSAP certificate (all countries) obtained in the EU.
1) if I want to sell my product outside of the MDSAP countries (e.g. China), I need to also satisfy the destination requirements
2) if I want to sell my product inside of the MDSAP countries (e.g. Canada), my product fits the requirements listed for the MDSAP certification, and I satisfy those having a MDSAP certificate, I can sell in any of the MDSAP countries without restrictions
3) if I want to sell my product inside of the MDSAP countries (e.g. Canada), but my product doesn't fit the requirements listed for the MDSAP certification (e.g. electronic IFU), then I can sell my product in any of the MDSAP countries without restrictions
-- as long as I meet my local EU (MDR) requirements on eIFU OR
-- if I meet the destination requirements on eIFU (in which case the idea of an MDSAP certificate covering all participating markets without restriction is lost).
Your input is highly appreciated,
Richard