Wholesale distributor

Under the FDA establishment registration rules, wholesale distributors are generally exempt from registering. The EU uses a broader distributor concept with its own obligations under MDR Article 14.

Wholesale distributor means any person (other than the manufacturer or the initial importer) who distributes a device from the original place of manufacture to the person who makes the final delivery or sale of the device to the ultimate consumer or user.

21 CFR, 807.3