Dear Colleagues,
My Company, a manufacturer of medical devices in cardiac surgery field, is considering to adopt website based electronic IFU, removing physical IFU (paper or CD) form product packaging.
A survey conducted among Distributors resulted in controversial feedbacks in Russia, Belarus, Kazakhstan and Ukraine; despite the absence of specific regulations, paper IFU/CD accompanying the product seem to be requested as a matter of fact to meet customer/commercial needs.
I would like a confirmation about the absence of regulatory constraints in the above countries for the removal of physical IFU, as well as information about any constraint of different nature (commercial, tenders, customs requirements, customer satisfaction...) which could hurdle the removal of physical IFU.
Thanks a lot and best regards,
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Giuliana Bernacca RAC
RA Compliance Manager
Sorin Group Italia S.r.l.
Saluggia
Italy
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