Dr. Manuela Reinhold

Distributor requirements (that also affect the manufacturers)

The medical device regulations have significantly increased the requirements for distributors. You need to understand these requirements to avoid multi-year custodial sentences threatened in the event of infringement. This article also considers extensive guidance issued by the Irish regulator. 1. What a “distributor” is (and what it isn’t) a) Definition The Medical Device Regulation (MDR) has many…

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