Regulatory Affairs - MEDKONSULT medical technology
We are a manufacturer of active devices with measuring function class IIa and we deliver our products with accessories from other manufacturers (e.g. catheters, electrodes, etc.). So far, we have no problem to provide documentation related to our own products but some competent authorities require a separate registration also for the accessories but, naturally, we do not have access to all the documents. Some suppliers are willing to provide it, others are quite reluctant as they consider some data to be confidential which is understandable, and in such cases, we try to reach a compromise.
But now, for the first time, one of our suppliers expresses their concern about selling their products through our company to the non-EU markets because they are worried especially about potential adverse events and how they would handle it, or how they would ensure the traceability of their products. Of course, we keep the track of the disposables we distribute, and the risk that an adverse event would be caused by their product is minimal, but I am not sure how to manage this situation and I kind of feel that, in fact, I don’t have very strong arguments to convince them to cooperate, apart from “but other suppliers did provide the documentation”.
Have you ever faced a similar problem? What are my options to reach an agreement with them? Are their concerns legitimate or can we somehow minimize any risk for them?
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