This page contains information about the requirements applicable to importers and distributors of medical devices.
To learn which requirements apply to you, it is important to determine your role under the Regulation. Please note that one operator can have only one role per a certain device under the Regulation. For example, a manufacturer can distribute a device, but that operator does not meet the definition of both a manufacturer and a distributor/importer.
NOTE! Due to the different dates of application of the new EU Regulations, the regulation of medical devices and that of IVDs differ somewhat during the transitional period.