Under the old medical device directives (MDD 93/42/EEC), the requirement for a distributor is not mentioned, while the word importer appears three times.
With multiple importers this can bring challenges as well as increase compliance risks as multiple economic operators are involved. If there are 2 distributors in a market and one distributor wants to be the importer and the other doesn’t, it means the label of the willing distributor will be added and shipped to all end-users. This could potentially create channel conflicts in the market.
As explained above, the idea behind the MDR importer regulations is to build in more safety protocols and would recommend designating separate entities within the Economic Operator supply chain to control and keep visibility on the traceability of goods. More-over it would facilitate additional compliance verifications and increased quality standards.
