Definitions of Importer and Distributor of Medical Devices
An importer is any individual or legal entity established within the European Union that brings a device from a third country onto the EU market for the first time.
A distributor is any individual or legal entity involved in the business of supplying devices on the EU market, whether for a fee or free of charge, until the devices are made available to end users.
Requirements Before Making a Medical Device Available on the Market
According to the MDR and IVDR regulations, importers and distributors of medical devices must provide data in the electronic system for traceability within the supply chain. This involves obtaining a unique single registration number (SRN), which importers request from the President of the Office, or access data to the system, which distributors request from the President of the Office.
Registration of Importers of Medical Devices
Before making a medical device, system, or procedure pack available for the first time on the EU market, importers must apply to the President of the Office for a single registration number (SRN). This application should include their identification details (in accordance with the National Court Register or Central Registration and Information on Business), including their Tax Identification Number (NIP). After verification in the relevant registers, the President of the Office will issue a unique SRN to the importer, which will be required when providing information about marketed products in the EUDAMED electronic system.
Detailed procedures for assigning the SRN are outlined in Article 19 of the Polish Medical Devices Act of April 7, 2022.
Starting from July 1, 2023, importers of custom-made devices will also be subject to this obligation.
List of Medical Device Distributors
The President of the Office will maintain a list of distributors with registered offices in the territory of the Republic of Poland. Starting from July 1, 2023, distributors can submit applications for an access code and password to be included in this list. The application should include their identification details, Tax Identification Number (NIP), phone number, email address, and website address (if applicable).
Once granted access to the system, distributors can enter their own data. Furthermore, they will be responsible for entering information about the imported products into the list.
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