Hi All,
We are manufacturers of surgical gloves based in India. We export to big distributors in Europe, who in turn supply to the end users in hospitals.
Since we do not supply gloves directly to the end user, we have no information on the usage pattern, the usability information or direct interaction on customer complaint. We usually get a feedback form from the distributors which usually has not much information on the actual usage.
Our notified body insists that we get some more detailed information from the end user. How do we get to that? Moreover, most of the customers have an OBL agreement with us and we supply in their CE number.
Could anyone kindly suggest an explanation to this dilemma? Is there any solution for this situation in the directive?
Thank you, in advance.
jose paul meleth